Writing Jobs 2025 (Now Hiring) – Smart Auto Apply

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.

This job is posted for Kaw Nation, and the direct contact will be hrclerk@kawnation.gov TITLE: ASSISTANT PROGRAM DEVELOPMENT/GRANT WRITING SPECIALIST IMMEDIATE SUPERVISOR: GRANT AND CONTRACTS DIRECTOR CONTROLLING SUPERVISOR: CHAIR LOCATION: KAW CITY, OK QUALIFICATIONS: Educational requirements include a High School diploma with at least one (I) year of experience in the grant writing/development field. An Associates Degree in Business, Accounting, or Office Administration is preferred. Additional experience may be substituted for educational requirements. Must possess and demonstrate excellent communication skills (verbal and written). Demonstrated organizational ability and an ability to meet deadlines. Must be familiar with funding research, identification of potential funding opportunities, federal grant program organization, and reporting methods. Must be able to process and disseminate information to the Program Development Specialists and/or Director. Must be able to multitask in a fast-paced environment. RESPONSIBILITIES: Responsible for proofreading grant applications prior to submission and recommending changes to Director. Responsible for researching potential funding sources. Responsible for maintaining/obtaining statistical information to use in support of grant applications and progress reports. Maintain Grant Status Report spreadsheet. Assist the Director in developing/maintaining the Program Development/Grants and Contracts policies and procedures manual. Must hold all information regarding the Nation in the strictest of confidence in all matters, responsibilities, and duties performed under this position. Assist with/complete any other job duties that might be assigned by immediate/controlling supervisor.

Primary Location: 9700 Wade Boulevard, Frisco, Texas, 75035 We are searching for candidates that meet the required qualifications and experience and are able to perform the essential duties and responsibilities. Job Summary: Provide tutoring support services to Collin College students. Help students understand the writing process, how to write thesis statements, how to organize and develop ideas and how to correct papers for sentence fluency, grammar, punctuation and diction. Required Qualifications: Essential Duties and Responsibilities Support students' writing efforts through tutoring. Maintain record of each tutoring session with student. Report promptly to student's professor on the material covered in the tutoring session (writing problems addressed) if applicable. Attend staff meetings or professional development as directed. Maintain confidentiality of student records in compliance with the Family Educational Rights and Privacy Act (FERPA).Ensure offices and files are adequately secured on a daily basis. Supplemental Functions Perform other duties as assigned. Perform all duties and maintain all standards in accordance with college policies, procedures and Core Values. Knowledge, Skills and Abilities Knowledge of college-level composition Knowledge of of the English language Knowledge of MS Word, Excel and Publisher Knowledge of MLA style and format Knowledge of presentation software Organization and time management skills Document design skills Creative thinking skills Presentation skills Computer and applicable software skills Interpersonal skills Ability to create a positive tutoring and learning environment in the writing center Ability to communicate effectively, both orally and in writing Ability to establish and maintain effective working relationships Physical Demands, Working Conditions and Physical Effort Sedentary Work - Exerting up to 10 pounds of force occasionally, a negligible amount of force frequently, and/or constantly having to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met. Positions in this class typically require talking, hearing, seeing, grasping, standing, walking and repetitive motions. Relatively free from unpleasant environmental conditions or hazards. Office environment. Little physical effort required. Requirements Tutor Instructional, Level IV - Bachelor's degree with relevant courses and/or skills connected to the tutoring subject required. Tutor Instructional, Level V - Master's degree with relevant courses and/or skills connected to the tutoring subject required. Preferred One (1) year of tutoring/teaching experience. Experience with ESL and/or Developmental Level Tutoring. Licenses and Certifications Official transcript(s) required. International transcripts require an English translation and a course-by-course evaluation from an approved agency. This position is generally limited to working a maximum of 19.5 hours per week. (Maximum hours for employees with more than one part-time position at Collin College may vary.) This position is Security Sensitive, therefore, candidates will be subject to a criminal background check. The above description is an overview of the job. It is not intended to be an all-inclusive list of duties and responsibilities of the job as duties and responsibilities may change with business needs. Collin College reserves the right to add, change, amend, or delete portions of this job description at any time, with or without notice. Reasonable accommodations may be made by Collin College in its discretion to enable individuals with disabilities to perform the essential functions. Required & Preferred Qualifications (if applicable): To be considered for this position, candidates must upload a copy of their transcript(s) confirming the completion of the required education or higher. Unofficial transcripts are acceptable. The intent of this job description is to provide a representative summary of the types of duties and responsibilities that will be required of the positions given this title and shall not be construed as a declaration of the specific duties and responsibilities of any particular position. Employees may be requested to perform job-related tasks other than those specifically presented in this description. Fair Labor Standards Act (exempt/non-exempt) is designated by position. The employer actively supports Americans with Disabilities Act and will consider reasonable accommodations. This is a Security Sensitive position. Therefore candidates will be subject to a criminal background check.* Compensation Type: Hourly Employment Type: Part time Compensation: $23.00 Hourly For any employment questions, please contact HR at (972) 985-3783 or send an email to: employment@collin.edu. Collin College is an Equal Opportunity Employer and does not discriminate on the basis of any characteristic protected by applicable law.

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.

At Freddie Mac, our mission of Making Home Possible is what motivates us, and it's at the core of everything we do. Since our charter in 1970, we have made home possible for more than 90 million families across the country. Join an organization where your work contributes to a greater purpose. Position Overview: Freddie Mac's Quality Control Department is seeking an accomplished professional with technical proficiency and a keen attention to detail to join us as a Quality Control Credit Risk Policy Professional. The ideal candidate will infuse energy and innovative thinking to overcome challenges in a fast-paced, dynamic environment. If you are eager to explore business value through collaborative tools, we encourage you to apply and become part of a team committed to ensuring quality. As a member of the QC Policy team in the Credit Risk Policy Professional role, you will engage in a variety of tasks, such as supporting the review of policies and procedures to ensure their appropriateness and adequacy, assisting in process mapping initiatives, and contributing to the creation of visuals and job aids to simplify complex activities. The preferred candidate should possess a strong aptitude for analyzing data and summarizing intricate information, collaborating effectively with diverse teams, producing clear and user-friendly documentation, and customizing SharePoint pages to optimize user experience. Our Impact: The QC Policy team is responsible for producing policies and procedures, job aids and other resources to teams within Quality Control, such as Underwriting Operations which conducts quality control reviews of loans purchased by Freddie Mac to ensure that the loans purchased by Freddie Mac meet the terms of business under which they were delivered. Your Impact: As part of the QC Policy team, you will create job aids and other written documentation utilized by the QC Underwriting team to ensure resources are accurate, clear, and equip our underwriters to deliver a consistent experience in alignment with the Freddie Mac Selling Guide. You will also develop or update resources for various teams within QC which support the Underwriting team, providing cross-functional direction where roles and responsibilities connect. Your daily responsibilities will include: Participate in the creation and updating of Quality Control documentation, including job aids, tools, and procedures. Efficiently manage and maintain SharePoint sites for various teams within Quality Control. Work on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends. Facilitate knowledge sharing sessions with subject matter experts and stakeholders across Single Family Quality Control by scheduling sessions, creating agendas, scribing meeting minutes and outlining action items and next steps, and following up to ensure next steps are executed. Qualifications: Typically has minimum of 2 - 4 years related experience in professional technical writing. Experience in the mortgage industry, including exposure or understanding of managing credit risk and familiarity with Freddie Mac Selling Guide. Ability to manage multiple projects within minimal supervision. Moderate to strong technical proficiency with MS Office, specifically Word and Excel, Adobe Acrobat and other databases. Intermediate knowledge of SharePoint is preferred, including familiarity with SharePoint architecture, experience creating lists and document/form libraries, and utilizing web parts. College Degree or equivalent work experience. Keys to Success in this Role: An extraordinary attention to detail. Quick to learn new technologies and tools, with the ability to provide technical guidance to the team. Strong written communication skills, capable of explaining concepts or new/updated processes clearly in writing. Ability to logically organize content. Exceptional reading comprehension with the ability to identify inconsistencies or gaps in documentation. Robust analytical and quantitative skills are essential. Capability to emulate the team's communication style to ensure consistency in terminology, tone, composition, and formatting across documentation. Comfortable interacting with internal management and partners within Freddie Mac. Strong problem-solving and critical thinking skills. Highly organized, with the ability to manage multiple assignments simultaneously and meet timelines, working independently without the need for significant guidance. Current Freddie Mac employees please apply through the internal career site. We consider all applicants for all positions without regard to gender, race, color, religion, national origin, age, marital status, veteran status, sexual orientation, gender identity/expression, physical and mental disability, pregnancy, ethnicity, genetic information or any other protected categories under applicable federal, state or local laws. We will ensure that individuals are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. A safe and secure environment is critical to Freddie Mac's business. This includes employee commitment to our acceptable use policy, applying a vigilance-first approach to work, supporting regulatory mandates, and using best practices to protect Freddie Mac from potential threats and risk. Employees exercise this responsibility by executing against policies and procedures and adhering to privacy & security obligations as required via training programs. CA Applicants: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. Notice to External Search Firms: Freddie Mac partners with BountyJobs for contingency search business through outside firms. Resumes received outside the BountyJobs system will be considered unsolicited and Freddie Mac will not be obligated to pay a placement fee. If interested in learning more, please visit www.BountyJobs.com and register with our referral code: MAC. Time-type:Full time FLSA Status:Non-Exempt Freddie Mac offers a comprehensive total rewards package to include competitive compensation and market-leading benefit programs. Information on these benefit programs is available on our Careers site. This position has an annualized market-based salary range of $85,000 - $127,000 and is eligible to participate in the annual incentive program. The final salary offered will generally fall within this range and is dependent on various factors including but not limited to the responsibilities of the position, experience, skill set, internal pay equity and other relevant qualifications of the applicant.

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.

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.

Ironwood Pharmaceuticals is a leading gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. One of the focus areas is on discovering, developing, and commercializing innovative treatments for patients with severe, rare conditions for which there is a significant unmet medical need. These conditions are challenging to diagnose, often devastating, and have limited, if any, treatment options. The lead product candidate, apraglutide, is a next-generation, best-in-class, synthetic peptide analog of glucagon-like peptide-2, or GLP-2, and is in Phase 3 for the treatment of patients with short bowel syndrome, or SBS, a malabsorption disorder caused by the loss of functional small intestine. It is an exciting time to join as Phase 3 is underway and the company is preparing for an initial launch in the coming years for which it is building out a commercial presence. The Senior Director of Medical Writing will have responsibility for executing a fit-for-purpose delivery model to produce a range of high quality clinical and regulatory documents to advance company goals across all investigational and marketed products. To achieve that aim, the Senior Director will collaborate with stakeholders across the Research & Development organization to understand priorities and needs. The Senior Director will initially oversee the selection and operation of external vendors and may eventually build an internal team to resource projects. The Senior Director will lead the development of processes and initiatives to ensure the consistent delivery of high quality, efficient medical writing services that comply with regulatory and internal guidelines. The Senior Director will represent the medical writing function on cross-functional teams for marketed and/or investigational products. The Senior Director will independently deliver clinical and regulatory documents that span the drug development lifecycle. The Senior Director will ensure high quality with regard to compliance with regulatory and internal guidelines, and the accuracy, consistency, and organization of documents. The Senior Director must be a proactive leader, effectively able to organize and collaborate with cross-functional teams to produce on-time, on-target documents that further the program goals. The Senior Director must have a strong understanding of drug development, clinical research concepts and data interpretation and presentation. Responsibilities: Maintain a long-term project forecast and resource plan to deliver all the documents required to advance company goals. Manage the selection of external vendors, from the initial preparation and review of completed Requests for Proposals through to contract negotiation and finalization. Independently author and manage others in creation of clear and concise, submission-ready clinical and regulatory documents. Manage the ongoing operations of high performing external vendors, including resource forecasting, contract change management, of oversight of vendor financials. Drive the ongoing development of processes, initiative, and tools to improve and enhance operations and to ensure compliance with regulatory standards and ICH/GCP/eCTD guidelines. Serve as a subject matter expert, advising and collaborating with cross-functional stakeholders on document strategy, authoring and review processes, and best practices. Represent Medical Writing and provide medical writing expertise on cross-functional teams. Develop detailed timelines for document development in line with company goals and SOPs. Write clinical and regulatory documents in accordance with applicable guidelines, regulations, practices, and procedures. Documents include, but are not limited to, clinical study protocols, clinical study reports, Investigator's Brochures [IBs], and Module 2 summaries of registration dossiers. Manage multiple rounds of team review through document finalization (ie, distribute documents for review; consolidate and resolve of reviewer comments; lead efficient cross-functional review roundtables). Ensure the accuracy, consistency, and quality of documents. Coordinate a formal quality control (QC) review of documents, as applicable. Coordinate with the Regulatory Operations team to publish documents that meet eSubmission‑ready standards. Collaborate with Data Sciences to review statistical analysis plans to ensure that the outputs planned meet data reporting needs and document templates. Lead the preparation of public disclosures of study results on national registries such as ClinicalTrials.gov and EU Clinical Trials Information System (CTIS), ie, coordinate with the external vendor to prepare the posting, distribute the posting for review, perform a quality control review [QC], consolidate and resolve reviewer comments, coordinate the redaction of required documents, notify the relevant stakeholders, in accordance with the company SOP and relevant regulations. Collaborate effectively across Ironwood and with Ironwood partner companies and external vendors, as applicable. Participate in the development of department SOPs and process-related tools to improve and enhance operations and to ensure compliance with regulatory standards and ICH/GCP/eCTD guidelines. Support medical writing and other cross-functional colleagues as necessary (eg, document review, format, and QC). Qualifications: BA/BS and 12+years of medical writing experience in the pharmaceutical or biotech industry; advanced degree preferred Success in managing resources (internal, external, or hybrid) Prior direct experience leading medical writing teams responsible for global marketing authorization applications Experience with a broad range of clinical regulatory documents spanning the drug development lifecycle Strong understanding of the drug development process, including regulatory requirements and ICH/GCP/eCTD guidelines. Working knowledge of drug development, clinical research, study design, biostatistics, regulatory, and medical terminology Excellent technical writing and editorial skills; excellent attention to detail Strong ability to understand and interpret medical and scientific data Proficient in Microsoft Word, PowerPoint, Excel, Project, and SharePoint Experience with automated document templates (eg, StartingPoint by Accenture), Adobe Acrobat and EndNote Excellent communication, interpersonal, and organizational skills Experience working on cross-functional teams Well organized; able to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to tight timelines Ironwood currently anticipates that the initial base salary for this position could range from between $239,000 to $278,565. The actual base salary will depend, in part, on the successful candidate's qualifications for the role, including education and experience. Ironwood offers a comprehensive compensation and benefits program to eligible employees, including Restricted Stock Unit awards; eligibility to participate in either a bonus or sales incentive program; company-sponsored 401(k) with matching contributions; eligibility for medical, dental, vision and prescription drug benefits; wellness stipends; and a generous vacation/holiday schedule. #LI-Hybrid

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.

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.

Have a passion for public speaking or writing? The Lipscomb University Center for Speaking and Writing (CSW) is looking to hire peer writing and speaking consultants beginning in Fall 2025. The goal of the new speaking center (as part of the CSW) is to assist students, faculty, and staff at Lipscomb university with public speeches and presentations at all levels. Speaking consultants will offer feedback to assist with strengthening the client's delivery, message, and overall confidence through advice and encouragement given throughout the session. May be federal work study eligible. Consultants will be expected to assist with: ● Topic selection ● Audience analysis / adaptation ● Content development ● Preparation outlines, delivery outlines and speaking notes ● Persuasive Presentations ● Informative Presentations ● Group Presentations ● Visual delivery (eye contact, posture, gestures, use of notes), ● Audio delivery (volume, enunciation, pace, inflection), ● Audio-visual aids ● Managing speaking anxiety Ideal candidates will: ● Have passed Intro to Communication (CO1003) or University Writing (EN1313) with a 'B' or better ● Have strong communication skills ● Enjoy working with others ● Maintain professionalism with peers After successful training, staff members will work in the center 3-10 hours per week performing the following tasks: ● Tutoring university students one-on-one ● Teaching workshops (including class visits) ● Attending mandatory staff meetings. Students will also be required to attend staff development before each semester begins.

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: People Leader All Job Posting Locations: Allschwil, Switzerland, Beerse, Antwerp, Belgium, High Wycombe, Buckinghamshire, United Kingdom, Leiden, Netherlands, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America, Toronto, Ontario, Canada Job Description: About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine We are searching for the best talent for Director, Medical Writing, Oncology. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): United States- Requisition Number: R-038874 Belgium & Netherlands- Requisition Number: R-039974 United Kingdom- Requisition Number: R-039973 Switzerland- Requisition Number: R-039972 Canada- Requisition Number: R-039966 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. Purpose: The Director of Regulatory Medical Writing (RegMW) is recognized as a leader with extensive medical writing expertise for documents across various therapeutic areas (TAs). This role is a primary liaison with cross-functional teams, driving strategic discussions, developing internal medical writers, and ensuring adherence to best practices and regulatory guidelines. The Director, RegMW has the authority to oversee projects, identify risks, and implement process improvements, while managing internal teams and contributing to organizational initiatives. Additionally, the role requires the ability to guide lead medical writers on one or several compounds with the same or different indications, leading within a team matrix environment, setting functional tactics, making strategic contributions, and proactively planning for resources. The Director will influence TA-level strategies, lead process working groups, champion internal standards, and improve internal systems and tools. You will be responsible for: Assume overall accountability for decision-making within the organization or TA, ensuring alignment with strategic goals. Proactively identify potential risks and develop strategies to mitigate them, enhancing project outcomes and minimizing obstacles. Recognize and resolve complex problems related to the development and implementation of new service offerings and deliverables, working independently to find effective solutions. Write or provide guidance to other writers on all types of clinical, regulatory, and safety documents, taking a proactive lead in content and scientific strategy with complete independence. Represent the MW department with decision-making authority in the R&D organization, leading discussions with senior cross-functional colleagues and external partners to enhance coordination between departments. Directly lead or set objectives for team projects and tasks, including leading program-level, submission, indication, and disease area writing teams independently. Serve as a liaison between team members and senior leadership within a TA or sub-function, facilitating effective communication and collaboration. Develop, implement, and drive the institutionalization of departmental process improvements and best practices in collaboration with relevant Communities of Practice and Business Process Owners, championing these initiatives to cross-functional team members. Mentor, support, and coach staff at all levels on document planning, processes, and content, providing peer review as needed. Maintain and disseminate knowledge of industry, company, and regulatory guidelines within relevant company systems. Participate in industry standards working groups to represent MW and ensure alignment with best practices. Accountable for setting the strategy and operational execution for their portfolio(s) within the Medical Writing (MW) team, in close consultation and accordance with the Delivery Unit (DU) Head and in line with R&D priorities and TA objectives. Recognized expert medical writer for any document within and across TAs. Accountable for MW resource management and allocation within their portfolio(s). Can represent MW DU Head or department at high-level and cross-functional TA meetings and has significant independent decision-making authority. Can step in for DU Head in case of absence. Is a major contributor to multiple deliverables for the function, TA, or DU. Provides leadership to their writing teams by helping attract and retain top talent, developing team members, and ensuring organizational effectiveness, transparency, and communication. Responsible for creating an environment where employees feel engaged and empowered, and take pride in their role, responsibilities, and deliverables. Takes on additional major responsibility with minimal supervision, operating at an expert level with accountability for the highest levels of quality: o Cross-functional, cross-TA, cross-J&J initiative/collaboration. o Larger organizational responsibility (eg, manage a subset of functional area/TA organization) with some level of independence to operate within that subset of the organization. Supervises/manages and is accountable for direct reports. Sets objectives and agrees on goals for direct reports. Provides performance oversight, including providing feedback on performance and development. Regularly meets with direct reports to ensure appropriate development, projects, assignments, and issues are resolved. Ensures direct report's adherence to established policies, procedural documents, and templates. Participates in hiring staff, onboarding new staff, conducting career and talent development discussions for staff, goal-setting, end-of-year performance reviews, and compensation planning. If applicable, frequent engagement with staff and leading discussions on employee development and talent management. Qualifications / Requirements: A university/college degree in a scientific discipline is required. An advanced degree (eg, Masters, PhD, MD) is preferred. Minimum of 14 years of relevant pharmaceutical/scientific experience is required. Minimum of 12 years of relevant clinical/medical writing experience is required. Minimum of 5 years of people management experience is required. Expertise in project management and process improvement is required. Strong decision-making skills, strategic thinking, agility, broad vision is required. Other: Excellent oral and written communication skills. Attention to detail. Expert time management for self, direct reports (if applicable), and teams. Ability to delegate responsibility to other medical writers. Expert ability to lead and influence by example and stay focused (positive). Demonstrate integrity. Expert ability to motivate and develop best in class talent pipeline. Demonstrated ability to collaborate internally and develop effective partnerships with key business partners and customers. Creates a positive Credo-based work environment for staff members. Shows openness to new ideas and fosters organizational learning. The expected pay range for this position is $160,000 to $276,000. 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. Subject to the terms of their respective plans, employees and/or eligible dependents are 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. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, 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 Colorado- 48 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 Bereavement Leave- 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave- 80 hours in a 52-week rolling period10 days Volunteer Leave- 32 hours per calendar year Military Spouse Time-Off- 80 hours per calendar year For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits This job posting is anticipated to close on October 31, 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. The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market 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 & 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 contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: The anticipated base pay range for this position is : $160,000 - $276, 000 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are 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. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, 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

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 Associate Director, Medical Writing (Regulatory) will provide strategic and operational medical writing expertise to prepare high-quality clinical regulatory documents for Health Authority submissions. This position will collaborate across the organization to implement and maintain a standardized document development process for regulatory documents. This is a hybrid role typically requiring on-site presence at least 3 days per week. Responsibilities: Develop and execute strategies for organizing and preparing documents for regulatory health authority submissions Plan, prepare, write, edit, format, and finalize regulatory documents including IND, CTA/IMPD, NDA, MAA, clinical and non-clinical summaries, updates to regulatory submissions, meeting requests, briefing books, annual reports/development safety update reports (DSURs) Oversee document preparation activities and track progress against targets; produce timely and accurate status update reports Provide oversight of document quality and consistency for ease of review across multiple documents assembled in a regulatory dossier or briefing package Lead document review and comment resolution processes with cross-functional teams Leverage scientific expertise to write, review, and edit science-based documents such as those included in IND/NDA sections, meeting requests, briefing books and annual reports Coordinate the review and approval of documents Develop templates, style guidelines, and SOPs for regulatory documentation Ensure final documents adhere to standard operating procedures (SOP), good clinical practice (GCP), and International Council on Harmonization (ICH) requirements Preferred Education and Experience: JD/Paralegal degree with scientific background or advanced scientific degree (MS, PhD or PharmD) Regulatory medical writing experience in the pharmaceutical industry/CRO environment or equivalent experience writing technical materials for submission to regulatory authorities, legal entities and/or other audiences Able to compile, analyze, and present data clearly, concisely, and effectively Experience participating in submissions to the US FDA (IND, NDA) and EMA (MAA) Strong understanding of drug development and regulations (US, EU and ICH) Broad knowledge of relevant regulatory guidelines (e.g., FDA, EMA) and compliance requirements Proficiency with Electronic Common Technical Document (eCTD) templates Strong verbal and written communication skills to effectively collaborate with cross-functional teams and address regulatory queries The pay range that the Company reasonably expects to pay for this headquarters-based position is $144,800 - $212,900; 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.

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.

Application Instructions: External Applicants: Please upload your resume on the Apply screen. Your application will automatically populate your resume details, and you may verify and update data on the My Information page. IMPORTANT: Please review the job posting and load ALL documents required in the job posting to the Resume/CV document upload section at the bottom of the My Experience application page. Use the Select Files button to add multiple documents including your Resume/CV, references, cover letter, and any other supporting documents required in the job posting. The "My Experience" page is the only opportunity to add your required supporting document attachments. You will not be able to modify your application after you submit it. Current Mercer University Employees: Apply from your existing Workday account. Do not apply from the external careers website. Log in to Workday and type Jobs Hub in the search bar. Locate the position and click Apply. Job Title: Assistant/Associate Professor of Writing and Interdisciplinary Studies Department: Liberal Studies College/Division: College Of Professional Advancement Primary Job Posting Location: Macon, GA 31207 Additional Job Posting Locations: (Other locations that this position could be based) Atlanta, GA 30341, Lithia Springs, GA 30122, McDonough, GA 30253 Job Details: Mercer University's College of Professional Advancement invites applications for an interdisciplinary Assistant or Associate Professor of Writing and Interdisciplinary Studies to join the Department of Liberal Studies. This is a full-time tenure-track position beginning August 1, 2026. Responsibilities: With twelve colleges and schools, Mercer University has a Carnegie Research II classification and offers a vibrant academic community committed to student success and academic excellence. This position will be based at one of Mercer's metro-Atlanta pr Macon campuses and includes a seven-course teaching load spread across four accelerated 8-week sessions in addition to research expectations and service responsibilities. Additional responsibilities include advising students, participating in faculty committees, attending faculty meetings, engaging in scholarly activity, maintaining on-site office hours, and working collaboratively with colleagues. The appointment is for the traditional nine-month academic year. Qualifications: The successful candidate must hold a Ph.D. in a discipline or field of the humanities or social sciences from an accredited institution at the time of appointment and sufficient education or experience to teach college writing. Demonstrated potential for exemplary teaching and the ability to translate that excellence into a fully online, accelerated format is expected. The successful candidate must be able teach general education courses in our Liberal Studies 100-level academic writing sequence, as well as interdisciplinary core courses for the B.A. in Liberal Studies. The successful candidate will be an outstanding teacher with an active scholarly agenda and a desire to contribute the life of the Department, College, and University by serving a post-traditional student population. Area of study is open, with a preference for candidates whose research apply methods of humanistic inquiry to engage contemporary concerns. The successful candidate must demonstrate the potential for teaching excellence and the ability to translate teaching excellence into a fully online, accelerated format for adult learners. Additional Information: The College of Professional Advancement's Department of Liberal Studies is an interdisciplinary department that serves the College's post-traditional student population by offering in-person, hybrid, and fully online B.A. degrees in Liberal Studies (a self-designed interdisciplinary major), World Humanities, and Communication. The Department also supports the University's General Education program. The department prioritizes high-impact teaching practices in service of student research and experiential learning. Ongoing departmental endeavors include the Coastal Georgia Research Initiative, a certificate in Globalization and Engagement, student e-portfolios, and study abroad experiences for working adults. Apply to join a collaborative group of teacher-scholars committed to educational equity through interdisciplinary inquiry. Required Documents: Interested candidates will complete a brief online application and attach required documentation including a letter of interest, curriculum vitae, teaching philosophy, and names and contact information of three references. Finalists for the position will be asked to have two current letters of recommendation sent directly to: Office of the Dean Writing & Interdisciplinary Studies Faculty Search College of Professional Advancement Mercer University 3001 Mercer University Drive Atlanta, GA 30341-4115 Unofficial transcripts may be requested from finalists as part of the recruitment process for this faculty position; finalists will need to redact any personal or private information including, but not limited to, social security number, birthdate, race, or gender, before submitting the unofficial transcripts. The successful candidate must submit official transcripts prior to employment. Deadline: Applications received by January 12, 2026 will receive priority consideration. Review of applications will continue until the position is filled. Background Check Contingency: Selection of the final candidate is contingent upon a successful background check. About Mercer University Founded in 1833, Mercer University is a distinguished private institution recognized for its commitment to academic excellence, leadership development, and community engagement. With campuses across Georgia, Mercer's twelve schools and colleges offer a wide range of undergraduate, graduate, and professional programs. The university cultivates a close-knit, student-centered environment where innovation, service, and personal growth are deeply valued. Mercer's employees are at the heart of its mission, dedicated to advancing innovation, supporting student success, and strengthening both our local and global communities through service. At Mercer, we believe in the power of relationships and the importance of in-person collaboration. Accordingly, our employees are expected to serve in-person as it fosters real-time problem solving, mentoring, and the meaningful connections that strengthen both our work and service to our students and the broader university community. Why Work at Mercer University Mercer University offers a variety of benefits for eligible employees including comprehensive health insurance (for self and dependents), generous retirement contributions, tuition waivers, paid vacation and sick leave, technology discounts, schedules that allow for work-life balance, and so much more! At Mercer University, a Bear is more than a mascot: it's a frame of mind that begins with a strong desire to make the most out of your career. Mercer Bears do not settle for mediocrity or the status quo. If you're seeking an environment where your passion and determination are embraced, then you want to work at Mercer University. For more information, please visit: https://hr.mercer.edu/prospective/ Scheduled Weekly Hours: 40 Job Family: Faculty Social Sciences EEO Statement: EEO/Veteran/Disability

Job Summary We are seeking a detail-oriented and experienced Senior Technical Writing/ Editing Specialist to join our dynamic team. The ideal candidate will possess exceptional editing and proofreading skills, with a strong background in technical writing. This role is crucial in ensuring that all technical documents are clear, concise, and accurate, meeting the highest standards of quality. The Senior Technical Editor will collaborate closely with writers, subject matter experts, and project managers to produce high-quality documentation that effectively communicates complex information. Location: Kirtland AFB, Albuquerque, NM Security Clearance: Secret (S) Classification: Technical Writer (SOC 27-3041) Experience Level: Senior Position Summary: The Senior Technical Writer will support the Joint Nuclear Weapons Publications System (JNWPS) Team by drafting, editing, and managing technical publications. This includes ensuring compliance with style guides and coordinating with internal and external stakeholders. Key Responsibilities:  - Draft and edit JNWPS publications and supporting documentation.  - Manage review cycles and consolidate feedback.  - Maintain publication tracking systems and logs.  - Upload documents to DIAMONDS and manage distribution.  - Provide editorial support for meetings and correspondence. Qualifications:  - Minimum 8 years of relevant experience with a BA/BS, or 6 years with a high school diploma.  - Proficiency in Adobe FrameMaker, Illustrator, Photoshop, and Acrobat.  - Strong attention to detail and ability to manage multiple projects. Join us as we strive for excellence in our documentation processes while fostering an environment of continuous learning and improvement. Job Type: Full-time Pay: $90,000.00 - $105,000.00 per year Benefits: 401(k) Dental insurance Health insurance Paid time off Vision insurance Schedule: Monday to Friday Work Location: In person Powered by JazzHR

Who We Are Fort Worth STEAM Academy (FWSA) is launching a tuition-free public charter middle school in East Fort Worth, opening August 2026. Our mission is to prepare every student for success in high school, college, and career through a rigorous STEAM-focused education, a joyful culture of high expectations, and strong community partnerships. As a founding team member, you won't just take a job—you'll help build a safe, structured, joyful school where curiosity and excellence thrive. Summary Middle School Teachers deliver TEKS-aligned instruction, build a safe, structured, joyful classroom, and use data to drive learning—so every student grows. You plan engaging lessons, analyze instructional data, provide accommodations with fidelity (IEP/504/EB), and partner with families and colleagues to ensure students meet ambitious goals. Reports to: Dean of Instruction Directly Manages: None Location: Fort Worth, TX (on-site) Compensation: 61K Schedule: Full-time, school calendar Anticipated Start Date: July, 2026 Who We're Looking For: Values-Driven and Mission-Focused This is a rare opportunity to help build a safe, structured, joyful public charter middle school where rigorous STEAM learning thrives. We're seeking teammates who live our values daily and turn them into student results. Achievement: Set bold, measurable goals, use data relentlessly, own outcomes, and prioritize high-impact work. Teamwork: Collaborate across roles, communicate directly with empathy, uphold high standards, and put the team above ego. Continuous Improvement: Seek feedback fast, find root causes, iterate on systems, and treat setbacks as learning data. Innovation: Spot problems early, test bold ideas quickly, share learnings, and scale what works to advance the mission. Key Responsibilities Professional Learning & Team Contribution Engage in weekly coaching and bi-weekly professional development sessions; implement bite-size action steps and reflect on results. Collaborate in Professional Learning Communities to align pacing, assessments, and student work analysis; share resources and model lessons. Support campus duties (arrival, transitions, lunch, dismissal) and take accurate attendance. Family Partnership & Communication Communicate regularly with families about progress, behavior, attendance, and upcoming learning (in plain language). Respond to family messages within school-day norms; participate in conferences, data nights, and school events. Assessment, Data & Acceleration Administer and analyze assessments; maintain an up-to-date gradebook. Plan targeted reteach, small groups, and accelerated instruction; progress monitor and adjust quickly. Ensure accommodations/designated supports are delivered with fidelity (IEP/504/EB) and reflected in lesson artifacts. Classroom Culture Teach and reinforce clear routines, procedures, and norms; utilize our school-wide behavior system with fidelity. Contribute to a campus culture where students feel known, safe, and motivated to do their best. Instruction & Planning Design/internalize daily lessons and unit plans aligned to TEKS , integrating literacy, writing, and STEAM practices. Differentiate for diverse learners (readiness, language, and IEP/504 needs); embed academic discourse and practice. Maintain an orderly classroom that maximizes learning and eliminates distractions. Minimum & Preferred Qualifications Minimum Qualifications Bachelor's degree. Valid Texas teaching certificate (core content required for Reading, Writing, Math, Science, Social Studies). Demonstrated success raising student achievement and maintaining a strong classroom culture. Skilled at using data (CFAs/interims) to plan instruction and intervention. Clear, compassionate communicator; organized; growth-minded; mission-aligned. Preferred Qualifications ESL certification (strongly encouraged for core content teachers). For Special Education roles: valid Texas Special Education certification (required). Experience with co-teaching, inclusive practices, and accommodations; familiarity with T-TESS, PLCs, and interim assessment platforms. Certifications/Licensure Required (Core Teachers): Valid Texas teaching certificate in assigned content/grade. Required (Special Education Teachers): Valid Texas Special Education certification. Encouraged: ESL certification. All Staff: DPS fingerprint clearance per Texas Education Code §22.0835.

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 Pacifica, 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 Pacifica, CA, Details: In-Person Tutoring in Pacifica, CA, Schedule: 16 hours, 2 sessions a week for 2 hours Pay range is between $25 and $35 Ideal Candidate: Experience working with students on the autism spectrum and/or other learning differences. Strong understanding of executive functioning, reading comprehension, and writing instruction. Knowledgeable in Science and Math at a high school level. Skilled at implementing structured, visual, and engaging instruction. Patient, calm, and able to manage challenging behaviors with consistency and positive reinforcement. Creative and adaptable, capable of incorporating student interests into lessons to boost motivation. Background in Special Education, ABA, or related experience preferred. Key Responsibilities: Provide structured support for homework, projects, and retention of key information from texts. Reinforce reading fluency, comprehension, writing organization, and language skills. Support executive functioning skills, including planning, task initiation, and organization. Incorporate social-emotional learning strategies to foster self-regulation and engagement. Utilize movement breaks, relaxation strategies, and student interests to maintain focus and motivation. Support basic academic concepts in Math and Science as needed. Maintain a calm, patient, and positive environment, adapting strategies to the student’s needs. Collaborate with caregivers and other service providers as appropriate. Optional: Conduct assessments to identify skill levels and inform instruction. 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.

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 Chino Hills, 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 Chino Hills, CA Details: In-Person Tutoring in Chino Hills, CA Schedule: 75 hours, 5 sessions for 2 hours Pay range is between $25 and $35 Ideal Candidate: Bilingual in Mandarin and English to support both the student and family communication. Experience working with students with Autism and/or other learning differences. Strong ability to support high school–level reading, writing, and comprehension . Skilled in providing clear, structured, and engaging academic instruction. Excellent communication, organization, and motivational skills. Preferred: Experience supporting neurodiverse learners or students transitioning from SPED to general education. Key Responsibilities: Provide in-person homework support across core subjects, with emphasis on English reading, writing, and comprehension. Reinforce classroom learning through structured practice and targeted academic interventions. Support the student in staying focused, completing assignments, and improving comprehension skills. Use the TME curriculum for additional instruction when homework is completed. Implement strategies that promote task completion, academic engagement, and sustained attention. Maintain open communication with the family in Mandarin regarding progress, needs, and session updates. Create a supportive, patient, and structured learning environment that fosters confidence and independence. 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.