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Johnson & Johnson logo
Johnson & JohnsonIrvine, CA

$129,000 - $174,000 / year

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function: Medical Affairs Group Job Sub Function: Medical Writing Job Category: Professional All Job Posting Locations: Irvine, California, United States of America, Irving, Texas, United States of America Job Description: Job Description About MedTech Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/ . Remote work options may be considered on a case-by-case basis and if approved by the Company. An internal pre-identified candidate for consideration has been identified. However, all applications will be considered. We are searching for the best talent for Sr. Writer, Scientific Operations Technical & Medical Writing. The Scientific Operations (SciOps) Sr. Writer will provide input and support to related functions ensuring the delivery of key regulatory and medical documents. Specifically, the Sr. Writer will lead the review of Clinical Evaluations (CERs), State of the Art Assessments (SOA), Literature Reviews, Summaries of Safety and Clinical Performance (SSCP), and Periodic Safety Updates (PSUR) for the MedTech Neurovascular business unit. Furthermore, the Sr. Writer will support interactions with the Notified Body and applicable Health Authorities and the drafting and alignment on response strategy and execution. You will provide leadership and maintain relationships through extensive partnering, benchmarking, and forming strategic alliances with cross functional business partners to drive key business goals and objectives. Additionally, you will lead SciOps activities/projects, including those supporting the Eudamed Readiness strategies for SSCP and PSURs in support of the EU MDR. Responsibilities: Support a team of managers and medical writers to strategize, synthesize and analyze product related safety and performance data, draft reports, coordinate approvals, and when applicable manage submissions to the Notified Body. Perform technical reviews ensuring the accuracy and compliance of Scientific Operations deliverables including Clinical Evaluation Plan (CEP), Clinical Evaluation Report (CER), Literature Review Protocol (LRP), Literature Review Report (LRR), Summary of Safety and Clinical Performance (SSCP), and Periodic Safety Updates Report (PSUR) documents. Track and trend Notified Body inquiries within business unit to identify trends, improve processes, and increase speed to market. Translate insights into viable processes and solutions that create value. Ensure the Scientific Operations deliverables are linked to appropriate Quality Systems and Regulatory documents (e.g. Risk Management, PMS, etc.) to make certain information is consistent and accessible where needed. S/He will develop, implement and manage an effective communication model for Scientific Operations deliverables with cross functional business partners. Assist in the development of schedules to ensure operating company deliverable timelines are met. Participate in workshops and lead projects/ initiatives to help define processes globally and keep abreast of MDR regulatory requirements and industry trends/practices, ensuring that a proactive ongoing review of processes and procedures is in place to maintain a strong regulatory profile while continually improving process efficiencies. Support audits and inspections pertaining to Scientific Operations processes and reports. Partner with cross-functional business partners such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs relating to the Scientific Operations deliverables Qualifications: Required Minimum of a Bachelor's degree (University Degree), in Life Sciences, Engineering or related subject area. Minimum of 5 years of experience in a regulated environment including 3 years of direct experience with medical devices in the fields of technical or medical writing, post market surveillance, clinical research, or product risk management. Preferred: Knowledge on physiology and common outcomes of neurovascular devices Experience within the medical device industry and knowledge of clinical evaluation report regulatory requirements, evidence generation, and CER document creation An advanced degree, MS, PhD, RN, or MBA. Demonstrated knowledge and experience in quality regulatory compliance, complaint handling, adverse event reporting, medical device risk management processes, and experience with common bio statistical methods Process Excellence / Six Sigma training or certifications. This position can be located remotely or in any one of our MedTech facilities with preferred locations in Irvine, CA. Additional Information: The anticipated base pay range for this position is $129,000 to $174,000. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Employees are eligible for the following time off benefits: Vacation- 120 hours per calendar year Sick time- 40 hours per calendar year; for employees who reside in the State of Washington- 56 hours per calendar year Holiday pay, including Floating Holidays- 13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave- 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave- 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave- 10 days Volunteer Leave- 4 days Military Spouse Time-Off- 80 hours Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits This job posting is anticipated to close on November 28, 2025. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource #LI-Remote Required Skills: Medical Writing, Post Marketing Surveillance, Technical Writing Preferred Skills: Business Writing, Clinical Research and Regulations, Clinical Trials Operations, Coaching, Collaborating, Communication, Copy Editing, Data Synthesis, Industry Analysis, Medical Affairs, Medical Communications, Problem Solving, Process Oriented, Proofreading, Quality Standards, Research Ethics, Standard Operating Procedure (SOP) The anticipated base pay range for this position is : $129,000 to $174,000 Additional Description for Pay Transparency:

Posted 4 days ago

Medica logo
MedicaSaint Louis, MO

$87,100 - $130,620 / year

Medica is a nonprofit health plan with more than a million members that serves communities in Minnesota, Nebraska, Wisconsin, Missouri, and beyond. We deliver personalized health care experiences and partner closely with providers to ensure members are genuinely cared for. We're a team that owns our work with accountability, makes data-driven decisions, embraces continuous learning, and celebrates collaboration - because success is a team sport. It's our mission to be there in the moments that matter most for our members and employees. Join us in creating a community of connected care, where coordinated, quality service is the norm and every member feels valued. The Manager, Proposal Development and Management is responsible for leading the creation of high-quality, persuasive, and professional proposal materials that support Medica's business growth, client retention, and brand credibility. This role oversees a team of communication professionals and plays a key part in shaping proposal strategy, content development, and execution to align with Medica's product and service offerings. Perform other duties as assigned. Key Accountabilities Lead the strategy and execution of RFP communications that enhance Medica's reputation as a trusted health plan Ensure the team responds accurately and timely to RFPs/RFIs/Questionnaires. Collaborate and build strong relationships with internal stakeholders and subject matter experts to write compelling and thorough proposal content Forecast RFP volume and develop resourcing plans to support team capacity. Manage the RFP content library including annual review and consolidation of content and management of technology vendor. Maintain the proposal database to provide weekly dashboard reporting on RFP tracking and status to stakeholders. Lead and develop a team of 12-18 The successful candidate will demonstrate strong leadership in managing a high-performing RFP response team, while exhibiting exceptional writing and editing skills with a focus on clarity, accuracy, and brand alignment. They will proactively develop and maintain proposal content and tools, effectively manage multiple projects and shifting priorities in a fast-paced environment and communicate confidently with executives and cross-functional teams. Required Qualifications Bachelor's degree in business, Communications, English, Marketing, Journalism or equivalent experience in related field 4 years of related experience beyond degree in the health insurance, HMO, or health care industry Writing portfolio for review Strongly Preferred Qualifications Experience managing proposal teams and developing strategic communications Familiarity with proposal automation tools such as RFP360 and RFPIO Proven ability to build and maintain relationships with internal stakeholders Experience in developing sales and business presentations for executive audiences Skills and Abilities Strong business leadership combined with proposal writing expertise Excellent written and verbal communication with attention to grammar and detail Advanced proficiency in MS Word, Excel, PowerPoint, and proposal automation tools Strong project management skills and ability to manage multiple priorities Exceptional interpersonal and relationship-building skills Ability to align content with brand standards and corporate identity This position is an Office role, which requires an employee to work onsite, on average, 3 days per week. We are open to candidates located near one of the following office locations: Minnetonka, MN, Madison, WI, Omaha, NE, or St. Louis, MO. The full salary grade for this position is $87,100 - $149,300. While the full salary grade is provided, the typical hiring salary range for this role is expected to be between $87,100 - $130,620. Annual salary range placement will depend on a variety of factors including, but not limited to, education, work experience, applicable certifications and/or licensure, the position's scope and responsibility, internal pay equity and external market salary data. In addition to base compensation, this position may be eligible for incentive plan compensation in addition to base salary. Medica offers a generous total rewards package that includes competitive medical, dental, vision, PTO, Holidays, paid volunteer time off, 401K contributions, caregiver services and many other benefits to support our employees. The compensation and benefits information is provided as of the date of this posting. Medica's compensation and benefits are subject to change at any time, with or without notice, subject to applicable law. Eligibility to work in the US: Medica does not offer work visa sponsorship for this role. All candidates must be legally authorized to work in the United States at the time of application. Employment is contingent on verification of identity and eligibility to work in the United States. We are an Equal Opportunity employer, where all qualified candidates receive consideration for employment indiscriminate of race, religion, ethnicity, national origin, citizenship, gender, gender identity, sexual orientation, age, veteran status, disability, genetic information, or any other protected characteristic.

Posted 30+ days ago

Johnson & Johnson logo
Johnson & JohnsonIrving, TX

$129,000 - $174,000 / year

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function: Medical Affairs Group Job Sub Function: Medical Writing Job Category: Professional All Job Posting Locations: Irvine, California, United States of America, Irving, Texas, United States of America Job Description: Job Description About MedTech Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/ . Remote work options may be considered on a case-by-case basis and if approved by the Company. An internal pre-identified candidate for consideration has been identified. However, all applications will be considered. We are searching for the best talent for Sr. Writer, Scientific Operations Technical & Medical Writing. The Scientific Operations (SciOps) Sr. Writer will provide input and support to related functions ensuring the delivery of key regulatory and medical documents. Specifically, the Sr. Writer will lead the review of Clinical Evaluations (CERs), State of the Art Assessments (SOA), Literature Reviews, Summaries of Safety and Clinical Performance (SSCP), and Periodic Safety Updates (PSUR) for the MedTech Neurovascular business unit. Furthermore, the Sr. Writer will support interactions with the Notified Body and applicable Health Authorities and the drafting and alignment on response strategy and execution. You will provide leadership and maintain relationships through extensive partnering, benchmarking, and forming strategic alliances with cross functional business partners to drive key business goals and objectives. Additionally, you will lead SciOps activities/projects, including those supporting the Eudamed Readiness strategies for SSCP and PSURs in support of the EU MDR. Responsibilities: Support a team of managers and medical writers to strategize, synthesize and analyze product related safety and performance data, draft reports, coordinate approvals, and when applicable manage submissions to the Notified Body. Perform technical reviews ensuring the accuracy and compliance of Scientific Operations deliverables including Clinical Evaluation Plan (CEP), Clinical Evaluation Report (CER), Literature Review Protocol (LRP), Literature Review Report (LRR), Summary of Safety and Clinical Performance (SSCP), and Periodic Safety Updates Report (PSUR) documents. Track and trend Notified Body inquiries within business unit to identify trends, improve processes, and increase speed to market. Translate insights into viable processes and solutions that create value. Ensure the Scientific Operations deliverables are linked to appropriate Quality Systems and Regulatory documents (e.g. Risk Management, PMS, etc.) to make certain information is consistent and accessible where needed. S/He will develop, implement and manage an effective communication model for Scientific Operations deliverables with cross functional business partners. Assist in the development of schedules to ensure operating company deliverable timelines are met. Participate in workshops and lead projects/ initiatives to help define processes globally and keep abreast of MDR regulatory requirements and industry trends/practices, ensuring that a proactive ongoing review of processes and procedures is in place to maintain a strong regulatory profile while continually improving process efficiencies. Support audits and inspections pertaining to Scientific Operations processes and reports. Partner with cross-functional business partners such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs relating to the Scientific Operations deliverables Qualifications: Required Minimum of a Bachelor's degree (University Degree), in Life Sciences, Engineering or related subject area. Minimum of 5 years of experience in a regulated environment including 3 years of direct experience with medical devices in the fields of technical or medical writing, post market surveillance, clinical research, or product risk management. Preferred: Knowledge on physiology and common outcomes of neurovascular devices Experience within the medical device industry and knowledge of clinical evaluation report regulatory requirements, evidence generation, and CER document creation An advanced degree, MS, PhD, RN, or MBA. Demonstrated knowledge and experience in quality regulatory compliance, complaint handling, adverse event reporting, medical device risk management processes, and experience with common bio statistical methods Process Excellence / Six Sigma training or certifications. This position can be located remotely or in any one of our MedTech facilities with preferred locations in Irvine, CA. Additional Information: The anticipated base pay range for this position is $129,000 to $174,000. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Employees are eligible for the following time off benefits: Vacation- 120 hours per calendar year Sick time- 40 hours per calendar year; for employees who reside in the State of Washington- 56 hours per calendar year Holiday pay, including Floating Holidays- 13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave- 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave- 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave- 10 days Volunteer Leave- 4 days Military Spouse Time-Off- 80 hours Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits This job posting is anticipated to close on November 28, 2025. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource #LI-Remote Required Skills: Medical Writing, Post Marketing Surveillance, Technical Writing Preferred Skills: Business Writing, Clinical Research and Regulations, Clinical Trials Operations, Coaching, Collaborating, Communication, Copy Editing, Data Synthesis, Industry Analysis, Medical Affairs, Medical Communications, Problem Solving, Process Oriented, Proofreading, Quality Standards, Research Ethics, Standard Operating Procedure (SOP) The anticipated base pay range for this position is : $129,000 to $174,000 Additional Description for Pay Transparency:

Posted 4 days ago

Vertex Pharmaceuticals, Inc logo
Vertex Pharmaceuticals, IncBoston, MA

$157,600 - $236,400 / year

Job Description General Summary: The Associate Director, Medical Writing Science manages the overall operations of a team or major project and implements this through effective leadership. This role provides guidance and leadership for document development for regulatory filings and coordinates the clinical sections of more complex regulatory submissions, including organization, content, and resource requirements. This role applies advanced technical expertise and develops solutions to complex problems, fosters interdisciplinary understanding, and integrates Medical Writing Science department activities with those of other departments. This is a hybrid role which allows for 2 days per week remote work and 3 days per week in the Boston Fan Pier office. We offer a full relocation package. Key Duties and Responsibilities: Independently authors routine and complex clinical and regulatory documents Provides strategic input into program-level plans Deep insight into how different functions contribute to the successes of the team Aligns, coordinates, and builds consistent information and messages across clinical program(s) Provides leadership related to the activities of Medical Writing Science and manages a team Participates in developing and implementing goals and initiatives for Medical Writing Science Facilitates implementation of new technologies and initiatives related to the preparation of clinical documents Proactively anticipates risks, solves complex problems, and seeks out and implements process improvements Knowledge and Skills: Demonstrated aptitude for planning, managing, and optimizing department resources (e.g., staff, technology) to maximize and streamline the advancement of company goals and objectives Record of leadership, independence, and ability to solve non-routine, complex problems involving a broad range of issues Proven track record of anticipating potential problems and preparing contingency plans as needed Understanding of scientific disciplines beyond own specialty area Experience managing direct reports and guiding staff development Experience with marketing authorization application regulatory submissions Education and Experience: Bachelor's degree in relevant discipline Ph.D. (or equivalent degree) Typically requires 8 years of work experience and 2 years of supervisory/management experience, or the equivalent combination of education and experience #LI-AR1 #LI-Hybrid Pay Range: $157,600 - $236,400 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Remote-Eligible Flex Eligibility Status: In this Remote-Eligible role, you can choose to be designated as: Remote: work remotely five days per week and come into the office on occasion - you're always welcome on-site; or select Hybrid: work remotely up to two days per week; or select On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Remote Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

Posted 3 days ago

Edwards Lifesciences Corp logo
Edwards Lifesciences CorpSan Diego, CA

$106,000 - $149,000 / year

Imagine how your ideas and expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes. Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient's unmet clinical needs. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. How you will make an impact: As a key member of the Clinical Science team, the Sr. Specialist, Clinical Science/Medical Writing is responsible for supporting the development of regulatory and clinical documents for a dynamic portfolio of products across TMTT. Perform and maintain systematic literature searches, developing search terms and criteria, extracting relevant clinical data, and writing clear and concise summaries of the data to support the development of clinical evaluation reports and clinical study reports Develop routine, sustaining medical writing documents/deliverables; propose approaches to developing moderately complex documents/deliverables Review and provide thoughtful feedback on moderately complex cross-functional deliverables (e.g., clinical study data, risk management documents, IFUs, SSED) using clinical and technical knowledge Serve as the primary contact, negotiating deliverables, timelines, and resolving project-related issues with assistance, in collaboration with cross-functional stakeholders Assist in the implementation of continuous process improvements as it relates to medical writing Other incidental duties What you'll need (required): Bachelor's Degree in a related field with 5 years of related experience working in medical affairs, clinical affairs and/or clinical science What else we look for (preferred): Preferred Hybrid On Site in Irvine, Ca Advanced degree (Master's, PHD, Pharm D) Experienced with literature reviews and various publication databases including PubMed and Embase. Familiarity with the cardiovascular therapeutic area-including, but not limited to, structural heart interventions, coronary interventions, heart failure-and current treatment landscape; familiarity with clinical research and/or clinical trial experience. Familiarity with MEDDEV 2.7/1 and EU MDR for clinical evaluations. Familiarity with FDA PMA applications. Good knowledge of scientific research methodology, device development process, GCP, ICH guidelines and Global (US FDA, EU MDR) regulations. Experience working in a cross functional, collaborative environment and comfortable interacting with R&D engineers, regulatory specialists, physicians, statisticians, and support personnel. This position can be an onsite role based at Edwards Lifesciences' corporate headquarters in Irvine, California. Additional skills and general expectations: Demonstrated ability to work independently, ability to prioritize and manage multiple tasks simultaneously Excellent oral and written communication skills Experience with maintaining current, in-depth product knowledge including current developments, clinical literature review, as well as therapeutic and product operation knowledge Advanced working knowledge with the use of MS PowerPoint, MS Word, MS Excel, EndNote, and Adobe Acrobat Strong analytical, problem-solving, and scientific writing skills Strict attention to detail Ability to interact professionally with all organizational levels Ability to work in a team environment, including inter-departmental teams and representing the organization on specific projects Ability to build productive internal/external working relationships The Sr. Specialist will be an experienced medical device professional with strong scientific acumen and a commitment to putting patients first. Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California (CA), the base pay range for this position is $106,000 to $149,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. #LI-Remote Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

Posted 30+ days ago

Ryan, LLC logo
Ryan, LLCDallas, TX
Why Ryan? Hybrid Work Options Award-Winning Culture Generous Personal Time Off (PTO) Benefits 14-Weeks of 100% Paid Leave for New Parents (Adoption Included) Monthly Gym Membership Reimbursement OR Gym Equipment Reimbursement Benefits Eligibility Effective Day One 401K with Employer Match Tuition Reimbursement After One Year of Service Fertility Assistance Program Four-Week Company-Paid Sabbatical Eligibility After Five Years of Service The Senior Consultant provides advice and guidance to identify tax recovery opportunities through research of tax issues, analysis of data, reconciliations, and completion of complicated calculations. This includes delivering review and audit services for clients, preparing relevant documents, reports and/or client presentations, and gaining an understanding of clients methodology and business activities. A successful Senior Consultant should be able to demonstrate analytical and problem-solving skills, strong tax research skills, and effectively communicate with clients or taxing jurisdictions. This role may also requires certain supervisory tasks such as assigning work, training employees, and checking work for technical accuracy and completeness. They may also assists Managers in developing project workplans and scheduling associated project deliverables and be responsible for maintaining a positive team environment. Education and Experience: Four-year college degree from an accredited institution in practice-relevant area with 3+ years practice-relevant experience. Must have legal research and writing experience. JD with 0 to 3 years of experience in tax research and writing. Experienced paralegal with 5+ years of experience in tax research and writing. Excellent organization and time management skills, strong communication skills, and willingness to learn and be a team player. Computer Skills: To perform this job successfully, an individual must have beginner's knowledge of Microsoft Word, Access, Excel, PowerPoint, Outlook, and Internet navigation and research. Certificates and Licenses: Valid driver's license required. Supervisory Responsibilities: Requires limited supervisory responsibilities, including training peers and checking work for accuracy and completeness. Work Environment: Standard indoor working environment. Occasional long periods of sitting while working at computer. Occasional long periods of standing while copying. Position requires regular interaction with employees and clients both in person and via e-mail and telephone. Equal Opportunity Employer: disability/veteran

Posted 30+ days ago

Metropolitan State University of Denver logo
Metropolitan State University of DenverDenver, CO
Department English By applying to this posting, you are entering an applicant pool for affiliate faculty. Screening of applicants will take place when positions come available. The number of these temporary, part-time, non-tenure track academic positions varies from semester to semester, depending on the needs of the program. As such, not everyone in the applicant pool for this position will be contacted and/or selected to teach. About the University Established in 1965, Metropolitan State University (MSU Denver) was founded to serve students who were underrepresented in higher education whose life paths and experiences did not fit the traditional mold. Sixty years later, the University continues to serve over 16,000 of Colorado's extraordinary and diverse students, providing them with the foundation on which to build their unique aspirations. As the third largest public institution of higher education in Colorado, MSU Denver is a model university for today's college students. Proud of its federal designation as a Hispanic-Serving Institution that also offers graduate programs (gHSI) and the only Seal of Excelencia certified institution in Colorado, the University serves the most diverse undergraduate student population in the state, as well as the most first-generation students. Through affordable, flexible, and holistic education, MSU Denver helps students build essential skills grounded in a multicultural and global perspective that lead to undergraduate and graduate degrees, and career and life success. Position Summary The Department of English at Metropolitan State University of Denver (MSU Denver) invites applications for part-time affiliate faculty instructors of English (First Year Writing). For more information about the Department of English in our College of Letters, Arts, and Sciences, please visit: https://www.msudenver.edu/english . Responsibilities Teach one to nine credit hours per semester in the area of First Year Writing. Ability to teach day, evening, weekend, or off-campus classes as needed. Classes may be face to face or online. Candidates must have the ability to work with and be sensitive to the educational needs of a diverse, urban population. An affiliate faculty member's duties may include but are not limited to: teaching assigned classes in person or online by delivering course content to students, preparing course materials and lesson plans, grading student work, providing students with robust feedback in a timely manner, addressing student questions consistent with university, college/school, and department policies, advising, and providing online or in person academic support to students as needed and appropriate for the teaching assignment; providing instruction in assigned classes consistent with the content and learning objectives of the regular course syllabus and, if required, with department course coordination policies; and complying with university-wide student evaluation of instruction policies and peer observation policies. Applicants may be asked to teach in-person, online, or in hybrid capacities dependent upon course needs. The ability to adapt and learn new modes of instruction is highly encouraged. Candidates need to be sensitive to the educational needs of a diverse student population. Required Qualifications Master's degree in Rhetoric and Composition, Writing Studies, or English At least one year of experience teaching college-level composition Preferred Qualifications Doctorate in Rhetoric and Composition Evidence of coursework and/or research expertise in rhetoric and composition Two years' experience teaching college-level composition Terms of Employment Affiliate faculty are part-time, at-will employees hired to teach on a per credit hour basis for specific classes, usually on a semester-by-semester basis. Affiliate faculty are not eligible for benefit coverage under the University's benefit program. All such teaching assignments are dependent on budget and enrollment. Qualified candidates will be expected to teach in person/on campus upon hire. Salary for Announcement The final salary is based on the number of credit hours assigned at a rate determined by university policy. For more information, please view the pay rates under College of Letters, Arts, and Sciences: Affiliate-Rates-AY-25-26. How to Apply Candidates must apply online through MSU Denver's career site, https://www.msudenver.edu/careers . Complete applications will include the following required materials: CV Cover letter Copies of all unofficial transcripts (undergraduate and graduate) A list of three professional references and their contact information Applicants will notice on the application portal there is one location (the resume/cover letter submission field) to upload all required materials. Multiple documents can be submitted into this one field; alternatively, merge all documents into one PDF and upload. Once submitted, you will not be able to edit your application. Official transcripts will be required of the candidate selected for hire. Closing Date Open Until Filled Posting Representative Tanya Rogowsky Posting Representative Email trogowsk@msudenver.edu Benefits The University's benefits package is comprehensive and offers medical, vision and dental, free RTD pass, tuition reimbursement, as well as a life and supplemental insurance plans, retirement plans and other programs, such as access to a long-term disability (LTD) plan. Visit MSU Denver's benefits website to learn more. For a brief overview, please see: https://www.msudenver.edu/wp-content/uploads/2024/01/MSU-Benefit-Summary.pdf . The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at totalrewards@msudenver.edu. Background Checks Metropolitan State University of Denver is dedicated to ensuring a safe and secure environment for our faculty, staff, students, and visitors. To Assist in achieving that goal, we conduct background checks on all finalists for positions at the University prior to employment. Diversity Statement Metropolitan State University of Denver is a unique, access-oriented campus community that values diversity, equity, and inclusion in all its forms. Our student population consists of nearly 58% first generation students and over 50% students of color. We are a designated Hispanic Serving Institution located in downtown Denver. We create an equitable learning and working environment in concert with individuals who consistently demonstrate commitment to equity and inclusion. We greatly value the diverse identities and perspectives of our students, faculty, and staff and recognize that in order to achieve a just and equitable society, diversity must go beyond simple representation. It requires critical inquiry and dialogue and a commitment to action. We strive to provide a culture of belonging for all community members to achieve personal and professional success.

Posted 30+ days ago

The Culinary Institute of America logo
The Culinary Institute of AmericaSan Antonio, TX

$2,848 - $3,182 / undefined

The hiring rate for this position is as follows: Base rate is $2,848; rate with Master's Degree is $3,015; rate with Master's degree and two years of college-level teaching experience is $3,182. Hiring offers will be determined based on the final candidate's education and relevant experience. The recruiter can share more information about what the anticipated hiring salary would be based upon your specific qualifications during the selection process. Please apply to learn more about the benefits of working for the CIA. POSITION SUMMARY Culinary Institute of America Adjunct Faculty members are responsible for teaching students a high standard of professionalism. The primary responsibility of Adjunct Faculty is teaching and evaluating students. Adjunct Faculty members also maintain office hours, assist students who are having difficulty with studies, and honor college policies. College Writing (LITC-100) 3 credits Students will write and revise essays that demonstrate their ability to read and think critically, to incorporate evidence into the development of their ideas, and to articulate their responses persuasively. Readings may include essays, articles, literature, or literary criticism. Basic concepts of information literacy will be introduced. Grammar, usage, and mechanics will be reviewed as necessary. ESSENTIAL RESPONSIBILITIES Prepare daily lesson plans for classes and teach classes as requested and scheduled, in a manner consistent with the philosophy, policies, and guidelines of the institute. Work individually as an advisor for students who may need extra help, who have questions about course information, who want career guidance, or who need assistance in their studies. Provide regular and constructive feedback to students in an objective, consistent, and timely manner; evaluate and documents student performance using established methods and criteria; files course grades consistently and without prejudice. Evaluate and document student performance using established methods and criteria File course grades promptly within the specific timeframe allowed Compile and present instructional material at scheduled times and places in accordance with the College Catalog descriptions, course syllabi and outlines and class schedules as assigned. Utilize the established syllabus and textbook(s) for the course being taught Maintain record of student attendance, student progress, and grade distributions Maintain discipline and order during instructional activities Communicate through appropriate channels Enforce sanitation principles (appropriate to particular teaching assignment), attendance policies, the Institute's Professionalism, Uniform, and Hygiene Policy, and other academic policies. Supports the mission and policies of the Institute as well as the overall strategic direction of the Department of Continuing Education. Assume responsibility for equipment and facilities of the classroom Any and all other duties as assigned. REQUIRED QUALIFICATIONS Education: Bachelor's Degree. Master's Degree. Experience: One (1) year college-level teaching experience. REQUIRED SKILLS Strong interpersonal skills; excellent verbal and written communication skills; ability to effectively work with multiple teams across the organization. Ability to use sound judgment and discretion in handling sensitive student issues with confidentiality and discretion. Excellent written, verbal communication, and presentation skills required. Strong computer experience, which must include abilities to work effectively with MS Office suite products, i.e. Word, Excel, PowerPoint. Strong customer service skills. Moderate to strong organizational skills, detail oriented and thorough. Ability to work independently or in a team environment, and maintain collaborative relationships with all members of faculty and administration. Must have an excellent and welcoming presence in front of guests and employees. Moderate to strong presentation skills are required. WORKING CONDITIONS Regular work requires a great deal of sitting and standing for extended periods. Ability to lift and carry up to twenty-five (25) pounds (such as file boxes, binders, etc.) Please apply to learn more about the benefits of working for the CIA.

Posted 1 week ago

Edwards Lifesciences Corp logo
Edwards Lifesciences CorpMass, MA

$106,000 - $149,000 / year

Imagine how your ideas and expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes. Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient's unmet clinical needs. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. How you will make an impact: As a key member of the Clinical Science team, the Sr. Specialist, Clinical Science/Medical Writing is responsible for supporting the development of regulatory and clinical documents for a dynamic portfolio of products across TMTT. Perform and maintain systematic literature searches, developing search terms and criteria, extracting relevant clinical data, and writing clear and concise summaries of the data to support the development of clinical evaluation reports and clinical study reports Develop routine, sustaining medical writing documents/deliverables; propose approaches to developing moderately complex documents/deliverables Review and provide thoughtful feedback on moderately complex cross-functional deliverables (e.g., clinical study data, risk management documents, IFUs, SSED) using clinical and technical knowledge Serve as the primary contact, negotiating deliverables, timelines, and resolving project-related issues with assistance, in collaboration with cross-functional stakeholders Assist in the implementation of continuous process improvements as it relates to medical writing Other incidental duties What you'll need (required): Bachelor's Degree in a related field with 5 years of related experience working in medical affairs, clinical affairs and/or clinical science What else we look for (preferred): Preferred Hybrid On Site in Irvine, Ca Advanced degree (Master's, PHD, Pharm D) Experienced with literature reviews and various publication databases including PubMed and Embase. Familiarity with the cardiovascular therapeutic area-including, but not limited to, structural heart interventions, coronary interventions, heart failure-and current treatment landscape; familiarity with clinical research and/or clinical trial experience. Familiarity with MEDDEV 2.7/1 and EU MDR for clinical evaluations. Familiarity with FDA PMA applications. Good knowledge of scientific research methodology, device development process, GCP, ICH guidelines and Global (US FDA, EU MDR) regulations. Experience working in a cross functional, collaborative environment and comfortable interacting with R&D engineers, regulatory specialists, physicians, statisticians, and support personnel. This position can be an onsite role based at Edwards Lifesciences' corporate headquarters in Irvine, California. Additional skills and general expectations: Demonstrated ability to work independently, ability to prioritize and manage multiple tasks simultaneously Excellent oral and written communication skills Experience with maintaining current, in-depth product knowledge including current developments, clinical literature review, as well as therapeutic and product operation knowledge Advanced working knowledge with the use of MS PowerPoint, MS Word, MS Excel, EndNote, and Adobe Acrobat Strong analytical, problem-solving, and scientific writing skills Strict attention to detail Ability to interact professionally with all organizational levels Ability to work in a team environment, including inter-departmental teams and representing the organization on specific projects Ability to build productive internal/external working relationships The Sr. Specialist will be an experienced medical device professional with strong scientific acumen and a commitment to putting patients first. Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California (CA), the base pay range for this position is $106,000 to $149,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. #LI-Remote Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

Posted 30+ days ago

Edwards Lifesciences Corp logo
Edwards Lifesciences CorpMcallen, TX
Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients' quality of life and expand their potential treatment opportunities. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. How you'll make an impact: Act as primary contact for medical writing projects, working with other cross-functional Edwards departments and clients to set and meet internal and external deliverable timelines. Develop complex medical writing documents/deliverables such as clinical evaluation plans/report, post-market clinical follow-up plans/reports, and Summary of safety and clinical performance documents in a fast paced environment. Serve as the lead for negotiating deliverables, timelines, and resolving project-related issues in collaboration with cross-functional stakeholders Conduct literature searches and reviews, including developing search strategy, managing associated documentation, extracting relevant data, writing clear and concise summaries of the data to support the development of clinical evaluation reports. Act as representative in core team meetings in the development of regulatory submissions for EU Provide leadership, training, and guidance and act as a mentor to less experienced medical writers. Identify, recommend, and assist in the implementation of continuous process improvements as it relates to medical writing Other incidental duties assigned by Leadership What you'll need (Required): Bachelor's Degree in in related field, with 5 years experience of previous related experience in medical writing or equivalent work experience based on Edwards criteria Required What else we look for (Preferred): Proven expertise in Microsoft Office Suite including Word, PowerPoint, Access, and Excel Experienced with literature reviews and various publication databases including PubMed and Embase Familiarity with MEDDEV 2.7/1 and EU MDR for clinical evaluations. Excellent written and verbal communication skills including customer negotiating and relationship management skills Excellent problem-solving, organizational, analytical and critical thinking skills Full knowledge and understanding of policies, procedures and guidelines related to the development of scientific content Full knowledge of medical writing Good leadership skills and ability to influence change Strict attention to detail Ability to interact professionally with all organizational levels Ability to manage competing priorities in a fast paced environment Ability to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

Posted 2 weeks ago

Ivy Tech Community College logo
Ivy Tech Community CollegeIndianapolis, IN

$18+ / hour

Job Title: Part-Time Writing Tutor Location: Indianapolis Job Type: Part-Time Salary Range: $18.00/Hour Reports To: Tutoring Coordinator Who We Are: We are an open-access college that fuels Indiana's economy through excellence in teaching and proactive engagement with industry and community partners, embedded in a culture of innovation that empowers all students to learn and succeed. We are "higher education at the speed of life!" Our Values: Empathy: We stand with our students, partners, and communities. Integrity: We treat all with dignity and respect. Accountability: We deliver on our commitments. Agility: We innovate, iterate, and transform. Connectivity: We connect with partners to strengthen communities and ensure student success for all. About the Role: We are seeking a highly skilled Writing Tutor to join our team. In this role, you will leverage your technical and functional abilities to support the Ivy Tech Indianapolis Writing Center by conducting one-on-one tutoring in-person and virtually with Ivy Tech students and assisting leadership with additional tasks. The ideal candidate will have a proven track record of scaffolding and modeling the writing process, coaching writer development, championing customer service experiences, and a passion for delivering outstanding results in a dynamic environment. Key Responsibilities: The following is not to be construed as an exhaustive list. Other duties logically associated with this position may be assigned. All responsibilities will be conducted within the parameters of the Family Educational Rights and Privacy Act (FERPA), other applicable regulatory requirements, and professional standards. Use established Writing Center pedagogy and protocols to tutor students one-on-one at various points of the writing process, working on written documents that span a range of subjects and genres. Thoroughly document tutoring data. Sustain high quality customer service while facilitating back-to-back tutoring sessions. Apply advanced problem-solving skills to troubleshoot and resolve student questions and inquiries. Collaborate effectively with cross-functional teams-including faculty-utilizing transparent and empathetic communication to help elevate departmental services and contribute to team initiatives. Assist departmental leadership with marketing and outreach, including conducting class visits, tabling events, and leading relevant workshops for students. Assist with monitoring department's email communications to help schedule tutoring appointments for students. • Maintain an understanding of pedagogical trends and apply relevant skills in support of student success. Tutoring Tutor students with writing assignments following the established protocol in the Writing Center. Facilitate one-on-one support and student learning throughout the entire writing process. Complete a written report for each student upon the conclusion of each session. Collaborate with faculty and staff when necessary to ensure best possible outcomes for students. Professional Development Participate in the Writing Center's training and professional development throughout the semester. Utilize observation feedback to promote ongoing growth and tutor development. Customer Service Demonstrate strong customer service and/or student advocacy through a positive attitude of approachability, adaptability, strong problem-solving, collaboration, and desire to identify and support student success. Engage in behaviors that create an inclusive environment in which all people are valued, supported, and empowered to succeed. Take initiative to go beyond the easiest or surface answer for a student or stakeholder, and get to the root cause of the problem, question, or issue to solve it as quickly and professionally as possible. Other duties logically associated with the position may be assigned. All duties are to be carried out under the guidelines of FERPA. Education & Experience: While formal education or certifications may be beneficial, or even required for certain positions, what we need are candidates who can demonstrate the practical skills and experience necessary to excel in this role. A proven track record of tutoring, teaching, or coaching others through adult-writer development processes will be prioritized. Required Skills & Competencies: Technical Skills: Proficiency in composing rhetorically-savvy texts, with hands-on experience tutoring, teaching, or coaching others through learning and skill development processes. Proficiency with computer and web applications on various devices, including Windows PCs, MacBooks, and Google Chromebooks. Proficiency with Microsoft and Google Suites, Zoom, and email and chat applications. Communication Skills: Strong verbal and written communication skills, with the ability to articulate ideas clearly to diverse audiences, provide non-judgmental feedback, and build positive rapport with others. Problem-Solving: Ability to think critically, make decisions independently, and solve complex problems in a timely manner. Teamwork: Proven experience in collaborating effectively with diverse teams to achieve common goals. Preferred Additional Skills: Familiarity with writing center or rhetoric/composition pedagogies, academic writing genres, and tutoring best practices. Experience in teaching or tutoring writing at the college level, customer service, or similar environments. Ability to demonstrate a positive attitude of approachability and adaptability Must demonstrate ability to promote an environment that reflects the broad backgrounds represented by our students and employees and which every individual feels respected and valued. Ivy Tech Community College is an accredited, equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, ethnicity, national origin, marital status, religion, sex, gender, sexual orientation, gender identity, disability, age or veteran status. As required by Title IX of the Education Amendments of 1972, Ivy Tech Community College does not discriminate on the basis of sex, including sexual harassment in its educational programs and activities, including employment and admissions. Questions specific to Title IX may be referred to the College's Title IX Coordinator or to the US Department of Education Office of Civil Rights.

Posted 3 weeks ago

Corcept Therapeutics logo
Corcept TherapeuticsRedwood City, CA

$172,300 - $253,300 / year

Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators. In 2012, we received FDA approval of Korlym (mifepristone), the first approved treatment for hypercortisolism (Cushing's syndrome). Today, our team and collaborators continue to unlock the possibilities of cortisol modulation as a way to treat serious diseases. With more than 30 ongoing studies across a wide range of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advancing the possibilities of cortisol modulation. What began as a ripple of scientific truth is now poised to unleash a sea change of discovery representing a fundamental shift in the way we understand and treat disease. The Director, Medical Writing will collaborate with colleagues to write and/or oversee the development of high-quality, strategically aligned medical-writing deliverables supporting the regulatory requirements of a clinical development program, ensuring completeness, accuracy, and compliance with US and ex-US regulatory requirements. Responsibilities: Provide Medical Writing leadership in strategic project teams as the medical writing subject matter expert, including advising such teams on content, format, and style requirements for documents Manage in-house medical writing staff, vendors and contractors, providing guidance on prioritization, content, timeline development, and process management Mentor and support direct reports in the development of their skills and careers Author, co-author, critically edit, and format clinical/regulatory documents, including New Drug Applications (NDAs), protocols/protocol amendments, clinical study reports (CSRs), Investigator's Brochures, and other regulatory submissions as needed Collaborate with document authors, contributors, and reviewers to deliver on clinical documents, including effective communication to manage expectations, resolve issues, and ensure alignment on document timelines and content Lead the development/refinement of medical writing processes, SOPs, work instructions, templates, style and content guides, and document quality control to ensure efficient preparation of high-quality medical writing deliverables Maintain subject area expertise related to the company's investigational products, disease indications, and regulatory and publication guidelines Perform miscellaneous job-related duties and additional duties and responsibilities as needed Preferred Skills, Qualifications and Technical Proficiencies: Excellent writing skills coupled with good understanding of the drug development process and relevant regulatory guidelines Ability to write and edit complex material to ensure accuracy, clarity, consistency, and effectiveness Successful track record of working on complex clinical/regulatory writing projects across multiple therapeutic areas Excellent attention to detail, multitasking, prioritization, and flexibility Excellent communication skills with proven ability to interact in a cross-functional environment Understanding of the drug-development process, including research and development processes and objectives and the required documents Familiarity with US and European regulatory requirements and guidelines for documents; general knowledge of electronic Common Technical Document (e-CTD) requirements with respect to structure, format, and content Ability to analyze critically and synthesize complex scientific information from a range of scientific disciplines and clinical therapeutic areas Proficiency in use of MS Office applications (Word, Outlook, Excel, Powerpoint), Adobe Acrobat, electronic document management systems (eg, Veeva Vault, Box, SharePoint), and templates (eg, StartingPoint) Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based on changing priorities Demonstrated initiative and the ability to manage a variety of projects simultaneously with minimal supervision Ability to think strategically, be resourceful, and lead without formal authority Preferred Education and Experience: BA/BS degree in a scientific field required; advanced scientific degree (PhD, PharmD, or MS) preferred 10+ years (Director) of regulatory medical writing experience in the pharmaceutical industry (or an organization serving them), including experience managing a team and writing clinical study protocols, clinical study reports, investigator's brochures, clinical sections of Investigational New Drug (IND) submissions and New Drug Applications (NDAs); and understanding of the content of higher-level summary documents Knowledge of endocrinology, oncology, neurology and/or metabolic disease areas preferred The pay range that the Company reasonably expects to pay for this headquarters-based position is $172,300 - $253,300; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education. Applicants must be currently authorized to work in the United States on a full-time basis. For information on how Corcept collects, uses, discloses, protects, and otherwise processes personal information and an explanation of the rights and choices available to you with respect to your personal information, please refer to our Privacy Notice link. Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs. Please visit our website at: https://www.corcept.com/ Corcept is an Equal Opportunity Employer Corcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third-party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Corcept.

Posted 30+ days ago

T logo
Tutor Me EducationHawthorne, CA
At Tutor Me Education, we are revolutionizing the way students learn, and we're seeking passionate teachers and tutors with special education experience to provide 1:1 in-home tutoring in Hawthorne, CA ! If you're committed to making a difference in the lives of students with special needs and helping them achieve academic success, we want to hear from you! About the Role: As an Tutor at Tutor Me Education, you’ll provide personalized, one-on-one tutoring to students with special needs in their homes. You will be responsible for helping students with daily activities, offering moral support, and delivering tailored instruction based on their Individualized Education Plan (IEP). We are currently hiring for multiple positions across all cities in Hawthorne, CA Details: In-Person Tutoring in Hawthorne, CA Schedule: 4pm onwards, 2x a week Competitive hourly rate based on experience Ideal Candidate: Fluent in English and Spanish (bilingual required) Experience working with students with ADHD, sensory processing needs, or fine motor delays Strong understanding of early literacy and handwriting instruction Familiarity with IEPs, RSP support, and occupational therapy goals Patient, creative, and skilled at engaging students who struggle with motivation Ability to implement positive reinforcement and multisensory learning strategies Reliable transportation for in-home sessions in Hawthorne, CA Key Responsibilities: Provide targeted support in handwriting , focusing on letter formation, spacing, pencil grip, and writing endurance Use multisensory and adaptive techniques to help reduce sensory-related avoidance of writing tasks Support reading comprehension to reinforce academic growth alongside writing development Incorporate strategies aligned with IEP goals and occupational therapy recommendations Create a supportive, engaging environment that builds the student’s confidence and independence Collaborate with the family to maintain consistency and track progress over time Respect and build upon the student’s strengths, interests, and learning style Use bilingual (English/Spanish) communication to support both the student and family Why Tutor Me Education? At Tutor Me Education, we are dedicated to providing a nurturing, supportive environment where students can thrive. We pride ourselves on offering meaningful tutoring opportunities that make a lasting impact in the communities we serve. Whether you're looking for consistent hours or just want to make a difference, we have a place for you. Benefits: Performance-Based Pay Incentives Voluntary retirement program Referral program Flexible schedule Help students with special needs reach their full academic potential Equal Opportunity Employer: Tutor Me Education is proud to be an Equal Opportunity Employer, committed to diversity and inclusion. We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or veteran status. We encourage candidates from all backgrounds to apply. Diversity, Equity, and Inclusion: We are committed to fostering an inclusive workplace where every team member feels valued, respected, and empowered. Diversity drives innovation, and we believe it is essential for success.

Posted 30+ days ago

Columbus State Community College logo
Columbus State Community CollegeColumbus, OH

$18+ / hour

Compensation Type: Hourly Compensation: $18.00 Job Summary The Learning Support Specialist II (LSS II), Reading & Writing Lab performs the duties of a professional tutor. The LSS II tutors in-person and is expected to work with students, faculty, staff, and community members, either one-on-one or in small groups, to help them attain a deeper and more substantial command of the assigned subject matter. This role must be able to work with multiple writers and with other tutors present, in a shared tutoring space. The LSS II communicates with the department regarding individual progress and needs for students. This position is responsible for generating reports from tutoring software and sending them to his/her supervisor. The LSS II must have a strong command of the subject matter and be able to communicate it effectively to writers using a variety of methods and teaching tools. Tutoring Supplements learners' understanding and command of the material for which they are seeking assistance, according to the learning outcomes and best practices outlined by the Developmental Program in the English Department. Assists learners in the completion of course requirements, as well as providing basic instruction in the use of digital resources. Administrative/Clerical Functions Maintains order in course-related documents and binders, duplicating items when necessary. Files student submissions. Submits accurate timecard information on a timely basis. Communicates student issues to relevant instructors and/or lead instructors. Reports technology issues to lead instructors and/or appropriate departments. Uses the College's tutoring software as necessary. Continuous Learning & Mentoring Maintains a thorough knowledge of the material, as well as multiple instructional methodologies, to accommodate various learning styles. Attends tutor training sessions. Provides support to lead instructors and colleagues. Culture of Respect Fosters and maintains a safe environment of respect and inclusion for faculty, staff, students, and members of the community. Minimum Qualifications: Bachelor's Degree in English or a related field One (1) or more years of reading, writing, and grammar instruction and/or tutoring experience in a secondary or adult education environment. Additional License Requirement: State Motor Vehicle Operator's License or demonstrable ability to gain access to work site(s). Full Time/Part Time: Part time Union (If Applicable): Scheduled Hours: 20 Additional Information In order to ensure your application is complete, you must complete the following: Please ensure you have all the necessary documents available when starting the application process. For all faculty positions (Instructor, Annually Contracted Faculty, and Adjunct), you will need to upload an unofficial copy of your transcript when completing your aplication. Prior to submitting your application, please review and update (if necessary) the information in your candidate profile as it will transfer to your application. If you are a current employee of Columbus State Community College, please log in to Workday to use the internal application process. Thank you for your interest in positions at Columbus State Community College. Once you have applied, the most updated information on the status of your application can be found by visiting your Candidate Home. Please view your submitted applications by logging in and reviewing your status.

Posted 30+ days ago

Edwards Lifesciences Corp logo
Edwards Lifesciences CorpTucson, AZ
Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients' quality of life and expand their potential treatment opportunities. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. How you'll make an impact: Act as primary contact for medical writing projects, working with other cross-functional Edwards departments and clients to set and meet internal and external deliverable timelines. Develop complex medical writing documents/deliverables such as clinical evaluation plans/report, post-market clinical follow-up plans/reports, and Summary of safety and clinical performance documents in a fast paced environment. Serve as the lead for negotiating deliverables, timelines, and resolving project-related issues in collaboration with cross-functional stakeholders Conduct literature searches and reviews, including developing search strategy, managing associated documentation, extracting relevant data, writing clear and concise summaries of the data to support the development of clinical evaluation reports. Act as representative in core team meetings in the development of regulatory submissions for EU Provide leadership, training, and guidance and act as a mentor to less experienced medical writers. Identify, recommend, and assist in the implementation of continuous process improvements as it relates to medical writing Other incidental duties assigned by Leadership What you'll need (Required): Bachelor's Degree in in related field, with 5 years experience of previous related experience in medical writing or equivalent work experience based on Edwards criteria Required What else we look for (Preferred): Proven expertise in Microsoft Office Suite including Word, PowerPoint, Access, and Excel Experienced with literature reviews and various publication databases including PubMed and Embase Familiarity with MEDDEV 2.7/1 and EU MDR for clinical evaluations. Excellent written and verbal communication skills including customer negotiating and relationship management skills Excellent problem-solving, organizational, analytical and critical thinking skills Full knowledge and understanding of policies, procedures and guidelines related to the development of scientific content Full knowledge of medical writing Good leadership skills and ability to influence change Strict attention to detail Ability to interact professionally with all organizational levels Ability to manage competing priorities in a fast paced environment Ability to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

Posted 2 weeks ago

Suffolk University logo
Suffolk UniversityBoston, MA

$3,000+ / undefined

The Suffolk University McNair Scholars Program invites applications for a Verbal Reasoning and Analytical Writing for Spring 2026. This position is designed to strengthen scholars' academic skills for success in graduate-level study. In accordance with 34 CFR § 647.30(a), this time-limited role constitutes "activities of an academic or scholarly nature … which have as their purpose the encouragement and preparation of project participants for doctoral studies." The McNair Scholars program supports first-generation and income-eligible college students who have demonstrated a commitment to preparing for and pursuing research doctorates. Appointment: February - March/April 2026 (8 weeks) Schedule: ~2-hour, in-person, class session per week; evenings, class time to be determined in conjunction with McNair program director; no classes week of March 9th due to Spring Break Type: Time-limited, seasonal instructor Pay: $3,000, flat-rate, per course, paid bi-weekly in accordance with the University pay schedule This position is grant funded by the U.S. Department of Education's McNair Scholars Program Award # P217A220037 at Suffolk University Responsibilities The Verbal Reasoning and Analytical Writing instructor will lead an eight-week, in-person, academic class series that strengthens advanced reading comprehension, critical reasoning, and written argumentation for graduate study. Core Topics may include: Reading comprehension and evidence-based analysis of complex texts Vocabulary in context and verbal inference Logical reasoning and argument evaluation Analytical writing: structure, argumentation, and clarity The Verbal Reasoning and Analytical Writing Instructor will be expected to: Design and facilitate weekly two-hour classes emphasizing conceptual understanding and applied reasoning. Integrate analytical exercises that mirror graduate-level expectations without functioning as commercial test-preparation instruction. Connect quantitative reasoning to research design, data analysis, and doctoral-level inquiry. Provide brief formative assessments and individualized feedback to track progress. Offer limited individual or small-group tutoring sessions, by appointment, to reinforce class material and address specific learning needs. Coordinate with McNair staff on instructional planning, attendance documentation, and content summaries for grant reporting. Combined Appointment Option The McNair Program is looking for instructors in both quantitative reasoning and verbal and analytical-writing instruction. Applicants with demonstrated expertise in both quantitative reasoning and verbal or analytical-writing instruction may be considered for appointment to both instructional tracks during the same spring term. If you are interested in being considered for both, you may submit all materials to the one job posting that would be your preferred subject, but please make your interest and qualifications for both positions explicit in your cover letter. Qualifications Bachelor's degree required; master's degree or higher preferred in a relevant discipline Demonstrated experience teaching or tutoring college-level students in the relevant content area. Proven ability to design engaging, scaffolded instruction that develops academic and analytical skills necessary for graduate study. Commitment to equity-minded pedagogy and mentorship of first-generation and low-income scholars. Familiarity with graduate-level academic expectations preferred. Familiarity with and/or working with federal TRIO program populations preferred a complete submission includes the following components: (1) CV/Resume; (2) Cover Letter detailing the rationale for applying to the role and relevant qualifications; (3) Recent Teaching Evaluations (if available). Applications without cover letters will NOT be considered. If candidate is a finalist, three professional references will be required before a final offer is made. Review of applications will begin immediately. Salary: $3,000.00 per course

Posted 2 weeks ago

Allegion plc logo
Allegion plcTempe, AZ

$55,000 - $65,000 / year

Creating Peace of Mind by Pioneering Safety and Security At Allegion, we help keep the people you know and love safe and secure where they live, work and visit. With more than 30 brands, 12,000+ employees globally and products sold in 130 countries, we specialize in security around the doorway and beyond. Additionally, in 2024 we were awarded the Gallup Exceptional Workplace Award, which recognizes the most engaged workplace cultures in the world. Specification Writer Apprenticeship Program; Phoenix/Tempe, AZ Specification Writer Apprentice We are looking for Specification Writers to join our Allegion team as part of our Specification Writing Apprenticeship Program! As a Specification Writer in the program, you will complete two rotations in the span of 9 months. This immersive program includes in depth training and development to prepare you for your role of providing access solutions by creating door hardware specifications. In the first six months of the training program, you will relocate to our training facility in Denver, Colorado. Here you will participate in classroom style training with others in your cohort. During this segment, you will learn about the industry, our products, and codes as well as how to read blueprints. In the last three months of the training program, you will transfer to your permanent location in your respective regional sales office. Here you will prepare for your full-time role by writing specifications with the help and supervision of your team so that you are prepared to hit your market ready for success! Hybrid: At Allegion, we are driven by a bold vision: redefining safety while empowering our employees to thrive. When you join our team, you become part of a culture that values innovation, purpose, and excellence. This role offers the benefits of our dynamic hybrid work model-combining in-person collaboration for meaningful moments with the flexibility of remote work. Since hybrid arrangements can vary based on the needs of the individual, team and business, your talent acquisition partner will provide specific hybrid details about this role. We are committed to fostering a healthy work-life balance and building meaningful connections, ensuring you have the tools, resources, and support needed to excel in any environment. Together, we'll unlock your potential and create a lasting impact. While this is the current structure and we currently have no plans to change, we reserve the right to make changes to the hybrid schedule as needed at the Company's discretion. Qualified candidates must be legally authorized to be employed in the United States. The company does not intend to provide sponsorship for employment visa status (e.g., H-1B, TN, etc.) for this employment position. What You Will Do: Rotational Training Key Elements: Complete immersive SWAP training program curriculum to increase knowledge about Allegion customers, products and processes. Participate and engage in various manufacturing trainings, product training and program events to deepen you understanding of Allegion systems, processes and customers. Immerse yourself in Allegion's culture by attending networking and professional development events to gain valuable relationships throughout the organization. Learn and master Allegion's state of the art tools, systems, and resources. Graduate from 9-month training program with in depth knowledge of role, best practices, policies, guidelines, and procedures to ensure best in class customer experiences. Full Time Role Responsibilities: Create technical hardware sets and specifications for the architectural community, including code compliance for new construction projects as well as aftermarket requests. Provide solutions to architects on product application requirements. Participate in pre and post installation meetings as needed and assist with revisions, access control coordination, and requests for information during all phases of the project. Exhibit a basic understanding of electro-mechanical products and solutions including access control and software. Communicate door hardware coordination requirements and/or conflicts, such as access control, electrical requirements, and specialty doors. Work in conjunction with Project Coordinator to provide a positive customer experience and deliver on project commitments. Maintain excellent industry/competitor product knowledge by reviewing and understanding market data of competitive activity. Adapt to changes in the marketplace. What You Need to Succeed: Associate's or Bachelor's degree in Construction, Architecture, or Technical field preferred Strong mechanical and electronics aptitude Excellent attention to detail with a high level of organization and time management skills Proficiency with MS Office tools Ability to learn industry specific software Exemplary verbal and written communication skills Ability to influence with actionable goals Why Work for Us? Allegion is a Great Place to Grow your Career if: You're seeking a rewarding opportunity that allows you to truly help others. With thousands of employees and customers around the world, there's plenty of room to make an impact. As our values state, "this is your business, run with it". You're looking for a company that will invest in your professional development. As we grow, we want you to grow with us. You want a culture that promotes work-life balance. Our employees enjoy generous paid time off, because at Allegion we recognize that you have a full life outside of work! You want to work for an award-winning company that invests in its people. Allegion is proud to be a recipient of the Gallup Exceptional Workplace Award for the second year in a row, recognizing our commitment to employee engagement, strengths-based development, and unlocking human potential. What You'll Get from Us: Health, dental and vision insurance coverage, helping you "be safe, be healthy" Unlimited Paid Time Off A commitment to your future with a 401K plan, which currently offers a 6% company match and no vesting period Health Savings Accounts- Tax-advantaged savings account used for healthcare expenses Flexible Spending Accounts- Tax-advantaged spending accounts for healthcare and/or dependent daycare expenses Disability Insurance- Short-Term and Long-Term coverage, paid for by Allegion, provides income replacement for illness or injury Life Insurance- Term life coverage with the option to purchase supplemental coverage Tuition Reimbursement Voluntary Wellness Program- Simply complete wellness activities and earn up to $2,000 in rewards Employee Discounts through Perks at Work Community involvement and opportunities to give back so you can "serve others, not yourself" Opportunities to leverage your unique strengths through CliftonStrengths assessment & coaching Compensation: This range is provided by Allegion. Your actual pay will be based on your skills and experience. The expected Total Compensation Range: $55,000-$65,000. The actual compensation will be determined based on experience and other factors permitted by law. Apply Today! Join our team of experts today and help us make tomorrow's world a safer place! Not sure if your experience perfectly aligns with the role? Studies have shown that some people are less likely to apply to jobs unless they meet every single qualification and every single preferred qualification of a job posting. At Allegion, we are dedicated to building a diverse, inclusive, and authentic workplace. So, if you're excited about this role but your past experience doesn't align perfectly with every item in the job description, we encourage you to apply anyway. You may be just the right candidate for this role. #ALLEGION We Celebrate Who We Are! Allegion is committed to building and maintaining a diverse and inclusive workplace. Together, we embrace all differences and similarities among colleagues, as well as the differences and similarities within the relationships that we foster with customers, suppliers and the communities where we live and work. Whatever your background, experience, race, color, national origin, religion, age, gender, gender identity, disability status, sexual orientation, protected veteran status, or any other characteristic protected by law, we will make sure that you have every opportunity to impress us in your application and the opportunity to give your best at work, not because we're required to, but because it's the right thing to do. We are also committed to providing accommodations for persons with disabilities. If for any reason you cannot apply through our career site and require an accommodation or assistance, please contact our Talent Acquisition Team. Allegion plc, 2023 | Block D, Iveagh Court, Harcourt Road, Dublin 2, Co. Dublin, Ireland REGISTERED IN IRELAND WITH LIMITED LIABILITY REGISTERED NUMBER 527370 Allegion is an equal opportunity and affirmative action employer Privacy Policy

Posted 3 weeks ago

Edwards Lifesciences Corp logo
Edwards Lifesciences CorpMaryland, LA

$106,000 - $149,000 / year

Imagine how your ideas and expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes. Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient's unmet clinical needs. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. How you will make an impact: As a key member of the Clinical Science team, the Sr. Specialist, Clinical Science/Medical Writing is responsible for supporting the development of regulatory and clinical documents for a dynamic portfolio of products across TMTT. Perform and maintain systematic literature searches, developing search terms and criteria, extracting relevant clinical data, and writing clear and concise summaries of the data to support the development of clinical evaluation reports and clinical study reports Develop routine, sustaining medical writing documents/deliverables; propose approaches to developing moderately complex documents/deliverables Review and provide thoughtful feedback on moderately complex cross-functional deliverables (e.g., clinical study data, risk management documents, IFUs, SSED) using clinical and technical knowledge Serve as the primary contact, negotiating deliverables, timelines, and resolving project-related issues with assistance, in collaboration with cross-functional stakeholders Assist in the implementation of continuous process improvements as it relates to medical writing Other incidental duties What you'll need (required): Bachelor's Degree in a related field with 5 years of related experience working in medical affairs, clinical affairs and/or clinical science What else we look for (preferred): Preferred Hybrid On Site in Irvine, Ca Advanced degree (Master's, PHD, Pharm D) Experienced with literature reviews and various publication databases including PubMed and Embase. Familiarity with the cardiovascular therapeutic area-including, but not limited to, structural heart interventions, coronary interventions, heart failure-and current treatment landscape; familiarity with clinical research and/or clinical trial experience. Familiarity with MEDDEV 2.7/1 and EU MDR for clinical evaluations. Familiarity with FDA PMA applications. Good knowledge of scientific research methodology, device development process, GCP, ICH guidelines and Global (US FDA, EU MDR) regulations. Experience working in a cross functional, collaborative environment and comfortable interacting with R&D engineers, regulatory specialists, physicians, statisticians, and support personnel. This position can be an onsite role based at Edwards Lifesciences' corporate headquarters in Irvine, California. Additional skills and general expectations: Demonstrated ability to work independently, ability to prioritize and manage multiple tasks simultaneously Excellent oral and written communication skills Experience with maintaining current, in-depth product knowledge including current developments, clinical literature review, as well as therapeutic and product operation knowledge Advanced working knowledge with the use of MS PowerPoint, MS Word, MS Excel, EndNote, and Adobe Acrobat Strong analytical, problem-solving, and scientific writing skills Strict attention to detail Ability to interact professionally with all organizational levels Ability to work in a team environment, including inter-departmental teams and representing the organization on specific projects Ability to build productive internal/external working relationships The Sr. Specialist will be an experienced medical device professional with strong scientific acumen and a commitment to putting patients first. Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California (CA), the base pay range for this position is $106,000 to $149,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. #LI-Remote Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

Posted 30+ days ago

Grand Valley State University logo
Grand Valley State UniversityAllendale, MI
Summary: The Department of Writing at Grand Valley State University invites applications for two Affiliate Faculty of Writing positions to begin Fall 2026. Applicants are expected to have an M.A., M.S., M.F.A., or PhD in English, Rhetoric/Composition, Writing or a closely related field. Candidates should have expertise and experience in teaching college composition to students from diverse backgrounds. Individuals from all backgrounds, including from underrepresented groups, are encouraged to apply. Successful candidates must be able to effectively engage with students, colleagues, and community members with a broad range of backgrounds and experiences. Required Qualifications and Education: M.A., M.S., M.F.A., or PhD in English, Rhetoric/Composition, Writing, or a closely related field. Experience and expertise in teaching college composition. Strong communication and interpersonal skills, such as the ability to interact with others with respect and cultural humility. Preferred Qualifications and Education: Graduate coursework in rhetoric and composition or its professional equivalent. Experience in or demonstrated commitment to inclusive pedagogical practices. Experience teaching with a range of technological tools to foster students' digital literacy skills. Responsibilities: The ideal candidate will focus their career on teaching general education first-year writing courses and on continuously developing their professional expertise as a writing instructor. Affiliate Faculty are full-time, teaching faculty with a typical full-time (9-month) teaching load of 12 credit hours per semester, drawn from GVSU's general education writing courses. The position is not tenure track, and there are no scholarship expectations or service obligations. Individuals will be appointed for one academic year on a full-time basis. This may be renewed once for an additional academic year. Thereafter, such individuals may be appointed for three (3) consecutive academic years. Minimum Starting Salary: $51,000; commensurate with experience. Benefits: Affiliate Faculty at GVSU are offered a comprehensive benefits package including medical, vision, dental, life insurance, generous employer retirement contributions, wellness resources and tuition waiver effective on date of hire. Department: The Department of Writing emphasizes teaching excellence using inclusive writing pedagogies. Full-time faculty uphold the values of a liberal arts education while providing a collaborative, experiential learning environment within writing studies. In addition to offering general education courses in first-year writing, creative writing, and professional communication, the department provides a unique 42-credit modular curriculum for students seeking a B.A. or B.S. in writing. College: The College of Liberal Arts and Sciences (CLAS) is the largest college at Grand Valley, offering over 50 bachelor's degrees and a growing number of advanced degrees in the natural and mathematical sciences, the fine arts and humanities, and the social sciences. CLAS is a student-centered learning community that welcomes individuals from various backgrounds and engages in critical inquiry, extending knowledge to enrich and enliven individual and public life. Our faculty are active teacher-scholars committed to offering students an accessible and community-engaged liberal arts and sciences education that prepares them for meaningful careers. There are many opportunities for collaboration within CLAS and across a broad group of partners on and off campus. We are interested in attracting a cohort of new faculty committed to these core values as we seek to foster a community where members from all backgrounds can live, learn, and thrive together. University: Grand Valley State University (GVSU) is a public comprehensive institution located in West Michigan with campuses in Allendale, downtown Grand Rapids, and Holland, plus centers in Detroit, Muskegon and Traverse City. The University attracts more than 22,000 undergraduate and graduate students with high quality programs and state-of-the-art facilities and has been nationally recognized for innovativeness and its contribution to students' social mobility. The greater Grand Rapids metropolitan area has a population of around one million people, is affordable, and offers rich cultural amenities. Grand Valley is located within easy driving distance of Chicago, Detroit, Lake Michigan beaches, and many other superb summer and winter recreational venues. Information can be found at the Community Resources page on Grand Valley State University Human Resources website. How To Apply: Apply online at GVSU Careers. To be considered for the position, applicants must upload the following items to the online application: A cover letter addressing qualifications and your motivation to teach at GVSU Curriculum vitae Teaching philosophy statement Graduate transcripts (unofficial transcripts issued to students are acceptable) The online application will allow you to attach these documents electronically, in the same file location. Applicants selected for interviews will be required to submit official transcripts prior to the interview. If you need technical assistance, email Human Resources (hro@gvsu.edu). Questions about the position may be directed to Department of Writing Chair, Amy Ferdinandt Stolley, at stolleam@gvsu.edu. Application Deadline: Consideration of applicants will begin on Monday, November 10, 2025. The posting may be closed at any time at the discretion of the University thereafter. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Must have the physical stamina to work long hours and/or more than 5 days per week. The requirements listed are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The information contained in this job description is for compliance with the Americans with Disabilities Act as amended by the ADA Amendment Act (2008), Section 504 of the Rehabilitation Act of 1973, and other applicable federal and state laws that prohibit discrimination on the basis of disability. GVSU will provide reasonable accommodations to qualified individuals with disabilities upon request. See www.gvsu.edu/equalopportunity/. TDD Callers: Call Michigan Relay Center at 711 (in State) or 1-800-833-7833 (out of State). Grand Valley State University is an Antidiscrimination/Equal Opportunity Employer, which includes providing equal opportunity for protected veterans and individuals with disabilities. University policy extends protections to additional identities.

Posted 30+ days ago

Trimble Inc logo
Trimble IncDayton, OH

$18 - $23 / hour

Your Title: Technical Writing Intern Job Location: Dayton, OH Our Department: IS Duration: Summer 2026 About Trimble's Internship Program As a Trimble intern, you will not only gain valuable hands-on experience, but you will also be given challenging, meaningful tasks that will give you insight into what it's like working full-time as a valued member of a team. Our internships are designed to prepare you for your career journey, while growing as a professional through lunch and learns, professional development courses, team building activities, and social networking events with other interns, whether you are in person or remote. Over the course of your internship, we want you to feel like you belong, innovate, and grow personally and professionally. Join Trimble's community to have a global impact where we value you, your experience, and your skills to propel your career forward. Job Summary Are you passionate about the power of words to inform, engage, and inspire? Do you excel at crafting clear, concise, and compelling content across a diverse range of formats to meet audience needs? The Google Workspace Platform Team at Trimble is seeking a full-time Technical Writing Intern to join our team in Dayton, OH. You'll have the opportunity to utilize your skills in the dynamic world of technical communication, where you'll have the chance to fully utilize and further develop your creative skills while contributing to real-world projects. If you're eager to learn, grow, and make a tangible impact within a supportive and forward-thinking environment, we encourage you to apply. Job Responsibilities You will work closely with the team to ensure all internal documentation for Google Workspace products is clear, current, and accessible. Key tasks include: Write, edit, and proofread articles, user guides, and internal announcements for the Google Workspace Training Hub that adhere to company guidelines and standards used by Trimble staff worldwide. Test product features and review existing documentation to confirm accuracy and completeness. Collaborate on content for AI systems, including updating and managing documentation pertaining to AI technology. Participate in and contribute to the team's processes for content review, documentation standards, and content calendar management. Bring a creative mindset to identify new ideas and opportunities for projects, tasks and processes to help improve business function and overall team effectiveness. Recommended Skills & Experience Rising Junior or Senior at an accredited college or university studying English, Communications, Creative Writing, Technical Writing, Marketing or a related field. Strong command of grammar, punctuation, and style, with a talent for writing clear, concise, and compelling content. Must have a general understanding and working knowledge of Google Docs, Sheets, and Slides. Strong ability to manage time, meet deadlines, and balance multiple priorities. Ability to quickly learn new technical concepts and work collaboratively in a team environment. Additional Skills & Experience Prior coursework or experience in technical writing or content development is a plus. Familiarity with AI concepts and an interest in documenting emerging technologies, not required, but a plus. Application Requirement Applicants must submit 3-5 professional or academic writing samples to demonstrate their technical communication abilities. Visa sponsorship is not available for this position. Candidates must already possess authorization to work in the United States of America without the need for employer sponsorship. Compensation: Trimble provides the following compensation range and general description of other compensation and benefits that it in good faith believes it might pay and/or offer for this position. This compensation range is based on a full time schedule. Trimble reserves the right to ultimately pay more or less than the posted range and offer additional benefits and other compensation, depending on circumstances not related to an applicant's sex or other status protected by local, state, or federal law. Hiring Range $18.32-$22.88 Pay Rate Type Hourly Bonus Eligible? No Commission Eligible? No Benefits: Trimble offers comprehensive core benefits that include Medical, Dental, Vision, Life, Disability, Time off plans and retirement plans. Most of our businesses also offer tax savings plans for health, dependent care and commuter expenses as well as Paid Parental Leave and Employee Stock Purchase Plan. If this position is identified above as commission- or bonus-eligible, the terms of the commission plan or discretionary bonus plan for which you are eligible will be provided following the employee start date. How to Apply: Please submit an online application for this position by clicking on the 'Apply Now' button located in this posting. Application Deadline: Applications could be accepted until at least 30 days from the posting date. At Trimble, we are committed to fostering a diverse, inclusive, and equitable workplace where everyone can thrive. Guided by our core values-Belong, Innovate, and Grow-we embrace and celebrate differences, knowing they make us stronger and more innovative. We are proud to be an equal opportunity employer, welcoming individuals of all backgrounds and advancing opportunities while embracing race, color, gender identity, sexual orientation, religion, disability, veteran status, or any other protected and diverse characteristic. We are committed to offering our candidates and employees with disabilities or sincerely held religious beliefs the ability to seek reasonable accommodations in accordance with applicable law and/or where it would not constitute undue hardship for Trimble. For more, please see Trimble's Code of Business Conduct and Ethics at https://investor.trimble.com , under "Corporate Governance." Our mission to transform the way the world works starts with transforming how we work together. By actively listening, asking questions, and taking intentional actions, we cultivate a culture that provides equitable opportunities for everyone to contribute and grow. Trimble's Privacy Policy If you need assistance or would like to request an accommodation in connection with the application process, please contact AskPX@px.trimble.com.

Posted 1 week ago

Johnson & Johnson logo

Sr. Writer, Scientific Operations Technical & Medical Writing

Johnson & JohnsonIrvine, CA

$129,000 - $174,000 / year

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Job Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Medical Affairs Group

Job Sub Function:

Medical Writing

Job Category:

Professional

All Job Posting Locations:

Irvine, California, United States of America, Irving, Texas, United States of America

Job Description:

Job Description

About MedTech

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

Remote work options may be considered on a case-by-case basis and if approved by the Company.

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

We are searching for the best talent for Sr. Writer, Scientific Operations Technical & Medical Writing.

The Scientific Operations (SciOps) Sr. Writer will provide input and support to related functions ensuring the delivery of key regulatory and medical documents. Specifically, the Sr. Writer will lead the review of Clinical Evaluations (CERs), State of the Art Assessments (SOA), Literature Reviews, Summaries of Safety and Clinical Performance (SSCP), and Periodic Safety Updates (PSUR) for the MedTech Neurovascular business unit. Furthermore, the Sr. Writer will support interactions with the Notified Body and applicable Health Authorities and the drafting and alignment on response strategy and execution.

You will provide leadership and maintain relationships through extensive partnering, benchmarking, and forming strategic alliances with cross functional business partners to drive key business goals and objectives. Additionally, you will lead SciOps activities/projects, including those supporting the Eudamed Readiness strategies for SSCP and PSURs in support of the EU MDR.

Responsibilities:

  • Support a team of managers and medical writers to strategize, synthesize and analyze product related safety and performance data, draft reports, coordinate approvals, and when applicable manage submissions to the Notified Body.

  • Perform technical reviews ensuring the accuracy and compliance of Scientific Operations deliverables including Clinical Evaluation Plan (CEP), Clinical Evaluation Report (CER), Literature Review Protocol (LRP), Literature Review Report (LRR), Summary of Safety and Clinical Performance (SSCP), and Periodic Safety Updates Report (PSUR) documents.

  • Track and trend Notified Body inquiries within business unit to identify trends, improve processes, and increase speed to market. Translate insights into viable processes and solutions that create value.

  • Ensure the Scientific Operations deliverables are linked to appropriate Quality Systems and Regulatory documents (e.g. Risk Management, PMS, etc.) to make certain information is consistent and accessible where needed. S/He will develop, implement and manage an effective communication model for Scientific Operations deliverables with cross functional business partners.

  • Assist in the development of schedules to ensure operating company deliverable timelines are met.

  • Participate in workshops and lead projects/ initiatives to help define processes globally and keep abreast of MDR regulatory requirements and industry trends/practices, ensuring that a proactive ongoing review of processes and procedures is in place to maintain a strong regulatory profile while continually improving process efficiencies.

  • Support audits and inspections pertaining to Scientific Operations processes and reports.

  • Partner with cross-functional business partners such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs relating to the Scientific Operations deliverables

Qualifications:

Required

  • Minimum of a Bachelor's degree (University Degree), in Life Sciences, Engineering or related subject area.

  • Minimum of 5 years of experience in a regulated environment including 3 years of direct experience with medical devices in the fields of technical or medical writing, post market surveillance, clinical research, or product risk management.

Preferred:

  • Knowledge on physiology and common outcomes of neurovascular devices

  • Experience within the medical device industry and knowledge of clinical evaluation report regulatory requirements, evidence generation, and CER document creation

  • An advanced degree, MS, PhD, RN, or MBA.

  • Demonstrated knowledge and experience in quality regulatory compliance, complaint handling, adverse event reporting, medical device risk management processes, and experience with common bio statistical methods

  • Process Excellence / Six Sigma training or certifications.

  • This position can be located remotely or in any one of our MedTech facilities with preferred locations in Irvine, CA.

Additional Information:

  • The anticipated base pay range for this position is $129,000 to $174,000.

  • The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.

  • Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

  • Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).

  • Employees are eligible for the following time off benefits:

  • Vacation- 120 hours per calendar year

  • Sick time- 40 hours per calendar year; for employees who reside in the State of Washington- 56 hours per calendar year

  • Holiday pay, including Floating Holidays- 13 days per calendar year

  • Work, Personal and Family Time - up to 40 hours per calendar year

  • Parental Leave- 480 hours within one year of the birth/adoption/foster care of a child

  • Condolence Leave- 30 days for an immediate family member: 5 days for an extended family member

  • Caregiver Leave- 10 days

  • Volunteer Leave- 4 days

  • Military Spouse Time-Off- 80 hours

  • Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

This job posting is anticipated to close on November 28, 2025. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource

#LI-Remote

Required Skills:

Medical Writing, Post Marketing Surveillance, Technical Writing

Preferred Skills:

Business Writing, Clinical Research and Regulations, Clinical Trials Operations, Coaching, Collaborating, Communication, Copy Editing, Data Synthesis, Industry Analysis, Medical Affairs, Medical Communications, Problem Solving, Process Oriented, Proofreading, Quality Standards, Research Ethics, Standard Operating Procedure (SOP)

The anticipated base pay range for this position is :

$129,000 to $174,000

Additional Description for Pay Transparency:

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