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Vertex Pharmaceuticals logo
Vertex PharmaceuticalsBoston, Massachusetts

$137,600 - $206,400 / year

Job Description General Summary: The Business Engagement & Technology Principal Analyst will be a technical resource in ensuring delivery and support of commercial-off-the-shelf (COTS) and a wide range of custom solutions in support of their business partners. The Business Engagement & Technology Principal Analyst will partner with business leadership to deliver capabilities and execute on a roadmap that align to support business strategy in Clinical Operations and Medical Writing . Additionally, the Business Engagement & Technology Principal Analyst will maintain reliable, scalable and compliant systems that easily meet business needs by efficient delivery and enhancements that provides opportunities for developing and implementing innovative solutions and integrations. Key Duties and Responsibilities: Become a trusted partner of the business leaders within their remit Understand their needs and vision, and deliver technology solutions to support and enable their goals and objectives Provide insights on how technology can improve business processes to enable operating efficiencies and support the achievement of business goals and objectives. Help refine and execute the technology strategy by leading the evaluation, selection, implementation, and ongoing maintenance of technology solutions. Develop and maintain a long term life cycle plan for the ongoing maintenance and management of systems. Manage relationships with our strategic software vendors and service providers Work closely with DTE Compliance, Internal Audit, and Quality Assurance groups as needed to ensure compliance with all appropriate regulations, as well as our DTE system lifecycle and change management requirements Serve as a liaison between GMDA and Data, Technology & Engineering (DTE) to ensure strategic alignment. Apply Agile, Lean, and design thinking methodologies to optimize solution delivery. Translate complex data into actionable insights and compelling business narratives. Monitor emerging technologies and trends to inform GMDA’s digital strategy. Drive change enablement and foster a culture of agility and continuous improvement. Knowledge and Skills: In-depth knowledge in the core disciplines of project management, business analysis, solution design, delivery, and testing Experienced in building productive partnerships with business stakeholders and aligning them around a recommendation/solution Strong understanding of the business (Clinical Operations/Medical Writing), processes, and any appropriate regulatory environments Expertise in data analytics tools (e.g., Tableau, Power BI, SQL) and enterprise platforms in the Clinical Operations space (e.g., Veeva, Suvoda, Salesforce). Deep understanding of GMDA functions including clinical development, regulatory affairs, and medical affairs. Results oriented contributor with a proven track record of on-time project delivery for large, complex projects with global stakeholders Able to manage own workload with minimal direction Very strong written and verbal communication skills and strong ability to present complex or sensitive information in a clear and concise manner to various technical and non-technical audiences Exceptional analytical, quantitative, problem-solving, and prioritization skills Strong system life cycle expertise Good knowledge of running IT managed services or outsourced/ offshore teams Exceptional communication and stakeholder engagement skills. Very strong MS Office skills, including MS Project & Visio, Excel and PowerPoint experience Experience in Agile methodology Ability to influence strategic decisions and drive alignment across diverse teams. Education and Experience: Bachelor’s degree in Information Technology, Business Administration, Life Sciences, or related field; advanced degree preferred. Minimum of 8 years of experience in business engagement, technology strategy, or data analytics within the pharmaceutical or biotechnology industry. PMP or equivalent project management certification preferred. Experience with AI/ML applications and digital transformation initiatives is a plus. Pay Range: $137,600 - $206,400 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid : work remotely up to two days per week; or select 2. On-Site : work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. #LI-Hybrid Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

Posted 1 week ago

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Cambri VenturesFayetteville, Georgia

$35,000 - $55,000 / year

Responsive recruiter Benefits: Bonus based on performance Free uniforms Opportunity for advancement Training & development Fish Window Cleaning is Hiring!Do you want to have a flexible schedule? Do you like to talk to people? Have you done sales in the past and enjoyed it? If any of these are a yes, then you maybe a great fit for this opportunity! We utilize a conversational selling technique that is enjoyable and not stressful. We are currently seeking a highly motivated individual to join us as an estimate writer. We are the largest and the best window cleaning company, you will have many benefits to offer prospective customers you meet including the most basic one, a free estimate. Our team enjoys the friendly atmosphere and the job flexibility. We work no nights, weekends or holidays! If this sounds like a good fit for you, apply to join our sales team today! Are you motivated to make sales? Typical Schedule: Mon-Fri 8am to 3:30 pm (Flexible) Pay: 10% Commission, Performance Bonuses, Growth Bonus Job Responsibilities: Friendly, outgoing personality Acquire new commercial clients through follow-up phone calls to key contacts made during estimating. Weekly, monthly, quarterly, or annual sales goals to meet. Excellent communication skills in person and on the phone. Demonstrated self-confidence and trustworthiness Driver’s license and reliable transportation. Good organizational skills and ability to follow-through on contacts made. Make bi-weekly follow up calls. FISH offers: On-the-job training Flexible Hours No nights, No weekend, No Holiday's Commission and bonus opportunities Uniforms Furnished Compensation: $35,000.00 - $55,000.00 per year Fish Window Cleaning has grown to be the world's largest window cleaning company with more than 250 franchise territories in 43 states, yet we still maintain the traditional values we were founded on. We will always treat every customer as though they are our only customer. Since its inception over three decades ago, Fish Window Cleaning has been dedicated to being a considerate and respectable neighbor in the communities where we work and live. FISH partners with nonprofit organizations on an ongoing basis to support causes across the United States. Through volunteering, leadership, and charitable giving, FISH lives its mission to be the best and most respected window cleaning company in the world. We are looking for courteous, self- motivated and friendly individuals that pay attention to detail. We clean glass at commercial and residential locations; including retail locations, office buildings, and malls from 1 to 3 stories. Some ladder work, travel between jobs, and minimal paperwork are required. You need reliable transportation, proof of insurance, and a valid driver’s license to be considered for employment. Thank you for your interest in Fish Window Cleaning ®. Fish Window Cleaning is a franchise. All Fish Window Cleaning locations are independently owned and operated. By clicking the apply button you understand that you are not applying to Fish Window Cleaning but rather an independent company that does business as Fish Window Cleaning.

Posted 3 weeks ago

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6045-Ethicon Legal EntityCincinnati, New Jersey

$137,000 - $235,750 / year

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function: Data Analytics & Computational Sciences Job Sub Function: Clinical Data Management Job Category: People Leader All Job Posting Locations: Cincinnati, Ohio, United States of America, Raritan, New Jersey, United States of America, Remote (US) Job Description: About Surgery Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech We are searching for the best talent for an Associate Director, Medical Writing & Literature Services . Remote work options may be considered on a case-by-case basis and if approved by the Company . Purpose : The Associate Director, Medical Writing and Literature Services acts as the central process owner for the general medical writing activities and systematic literature reviews across J&J MedTech Surgery in support of Clinical, Medical, and Regulatory needs. These medical writing activities and systematic literature reviews support the generation of clinical evaluation reports (CER), summaries of safety and clinical performance (SSCP), post-market surveillance reports (PSMR), periodic safety update reports (PSUR), new product development (NPD) evidence generation strategies, premarket approval (PMA) annual reports, and Health Authority requests for all therapeutic areas / operating companies / platforms within the J&J MedTech Surgery business unit. You will be responsible for : Directs the planning and execution of systematic literature reviews (inclusive of protocol, search, screen, data extraction, analysis, and full summary report) for all applicable deliverables and processes, ensuring timely delivery of high-quality literature services and documentation as well as consistent deployment across MedTech Surgery. Develops, implements, and maintains relevant procedures and templates, best practice and style standards, reference libraries, reviewer guidelines, and quality control tools/measures. Manages the utilization of software to support systematic literature reviews, including statistical analysis tools. Ensures the medical writing processes are linked to appropriate Quality Systems and Regulatory Processes (e.g., Risk Management, PMS, etc.), supporting data/information accessibility. Manages Medical Writing staff (i.e., medical writers and reviewers, project management staff, librarians, medical information specialists, programmers, as applicable to organizational structure). Provides strategic oversight and guidance for Medical Writing staff and cross-functional business partners, if applicable, to all resources on compliant literature service execution and document generation. Establishes and maintains resource allocation / forecasting and operational direction for direct reports to achieve high-quality deliverables in an efficient manner. Maintains responsibility for talent acquisition and comprehensive training. Supports the professional development of direct reports. Leads literature process optimization with focus on improving efficiency, automating, and standardizing literature searching and reporting, staying current with industry trends and regulations. Partners with Global Clinical Evaluation teams and cross-functional business partners such as Medical Affairs, Medical Safety, Post Market Surveillance, Clinical Affairs, Design Quality Engineers, R&D, and Regulatory Affairs relating to literature search and systematic review processes. Acts as the Global Clinical Evaluation literature services SME / liaison with respective Notified Bodies and regulatory agencies during audits and inspections. Tracks key performance indicators, maintains/monitors metrics, and reports issues or opportunities for improvement to Global Clinical Evaluation leadership. Supports the J&J MedTech literature subscription process, enabling and maintaining appropriate access to the journals for cross-functional teams. Assists in the development and management of the Global Clinical Evaluation budget including performing budget updates, ensuring appropriate assignment of resources, and approving invoices. Identifies and collaborates with vendors/service providers to source contract services necessary to accomplish literature services goals and objectives. Qualifications / Requirements: Minimum of a Bachelor’s Degree required ; Advanced Degree strongly preferred . Minimum 7 years of related medical writing experience including systematic literature reviews with minimum 3 years of people leadership experience required . Experience mentoring medical writers, managing high-volume project work, and supervising internal and external writers/vendors required . Experience within the medical device industry and with clinical evaluation report regulatory requirements required ; thorough understanding of global medical device regulations and guidelines (e.g., FDA, EU MDR) required . Demonstrated knowledge and experience in narrative or systematic literature reviews (e.g., PRISMA, Cochrane) with qualitative and quantitative synthesis in conjunction with scientific and medical writing required . Demonstrated knowledge and experience in clinical research methodologies with common biostatistical methods, systematic reviews and clinical data appraisal, and medical writing required . Change management expertise required . Certification or 2+ years of project management experience preferred . Experience developing and implementing literature search / reporting systems, processes, and tools required; knowledge of automation / artificial intelligence opportunities preferred . Experience in complaint handling, adverse event reporting, and risk management processes preferred . Knowledge of evidence generation strategies preferred . Regulatory/Notified Body front room audit experience preferred . Budgetary and financial planning experience preferred . Position can be performed remotely. 20% Domestic and International Travel required. 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. #LI-Remote Required Skills: Clinical Research Methods, Medical Device Regulations, Medical Writing, People Leadership, Scientific Literature Reviews Preferred Skills: Change Management, Clinical Evaluation Reports, Evidence Generation, Vendor Management The anticipated base pay range for this position is : The base pay range for this position is $137,000 to $235,750. 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)). 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

Posted 1 week ago

Johnson & Johnson logo
Johnson & JohnsonIrvine, California

$129,000 - $174,000 / year

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

Posted 2 days ago

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Fort Worth STEAM AcademyFort Worth, TX
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.

Posted 30+ days ago

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Clark Creative SolutionsAlbuquerque, NM

$90,000 - $105,000 / year

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

Posted 30+ days ago

ShipHawk logo
ShipHawkSanta Barbara, CA

$500+ / undefined

Technical Writing Internship This is an IN PERSON Internship in Santa Barbara, CA. Position Requirements: Part of the UCSB Professional Writing Program Senior at UCSB Live in the Santa Barbara area with the ability to work in the downtown office About ShipHawk ShipHawk is the premier warehousing and shipping software for ERP connected companies. We work with high volume retail, wholesale and eCommerce companies that have outgrown basic warehousing and shipping software. Come join us as we transform one of the last massive old-school industries into a transparent, efficient market, benefiting both retailers and consumers. Join a startup where you can make an impact, grow your career, and have a voice. About the Opportunity: Location: In Person at our Santa Barbara Headquarters Department: Product - Technical Writing Team Reports to: Senior Technical Writing Manager Technical Writers excel at clearly and accurately communicating complex information. As a Technical Writer Intern at ShipHawk, you will gain experience in creating and editing outstanding content while working with Technical Writers, Product Owners, and UX Designers. During your internship, you will support the Technical Writing team’s objectives and projects that drive the business forward. Expect to use Google Suite (Docs, Slides, Sheets), Confluence, LucidChart, and other tools to write, edit, and illustrate content for technical and non-technical audiences. We are looking for outstanding writers who love to learn and want to learn more about working in the software industry as a technical writer. This opportunity will include working on a variety of projects, including writing blog articles. 5 Reasons Why You Want to Work with Us: You want to work with a team that is competent, confident, passionate, and focused on achieving big goals. You want to work on a product with the potential to grow into a billion dollar business, become a household name, and help millions of people. You want to have a voice. You want to be part of a fun and healthy culture. You want to work at a company that will provide an opportunity to get to the next level of your career. What We’re Looking For In You: We are looking for an all-star skill set: efficient, organized and follows through on commitments. You're intelligent, have great analytical skills and pay attention to detail. In addition, you're calm under pressure, have a great work ethic and communicate well. And, more than the usual skills, we want you to push and not accept the mundane. Push for a higher standard. Be proactive. Be open to new ideas and personal feedback. Try stuff, fail and learn from it. 5% of business leaders are 20 times more efficient than 95% of business leaders. We want you to be the 5%. We would very much like to see any writing samples you may have. This internship is a great opportunity for upper level college students with a minor in professional writing. Some of the skills you will want for this internship: Strong writing, illustration, and multimedia content development skills Experience with online writing and publishing, including blogs, articles, newsletters, and wikis Interest in business, science, or technical writing as a career To get the most out of this internship, you will need to: Be available to work 10-15 hours per week Have an interest in pursuing a career in business and technical writing Have familiarity with technology and software as a service (SaaS) Be a self-starter Be organized and methodical Be coachable and able to acknowledge, digest and adapt to constructive criticism and feedback What we offer: Approximately five month long internship program February 3, 2026 - June 12th, 2026 $500 per month stipend 10-15 hours per week with flexibility to work with your schedule Work downtown in Santa Barbara Hands-on experience and opportunity to lead your own projects Ability to work in fun tech startup environment Be a part of a bigger internship cohort Work with renowned local SaaS tech company Being part of a driven, dynamic team Onboarding and final project Team building event with your fellow interns Network and build relationships within the community and make professional connections You will not make coffee, you will make an impact as part of the team! ShipHawk provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Posted 2 weeks ago

Guilford College logo
Guilford CollegeGreensboro, North Carolina
People are drawn to Guilford College for a number of reasons, including the College’s Core Values of community, diversity, equality, excellence, integrity, justice, and stewardship. Working at Guilford provides you with a rewarding opportunity to impact the developing lives of students from a range of diverse backgrounds . Guilford attracts those who are seeking a professional challenge and career advancement. It also attracts those who want to enjoy a beautiful campus and location in the dynamic city of Greensboro, North Carolina . Guilford College offers a wide range of benefits for full-time regular employees, including 13 paid holidays, tuition remission, health insurance, telemedicine, life insurance, short-term and long-term disability, a retirement plan, and optional dental and vision insurance. In addition, employment at the College provides employees with access to numerous discounts for products, services, and attractions. Position Summary The part-time faculty member will teach one or two first year writing courses. Faculty member is responsible for designing and teaching the course(s), as well as meeting with students, commenting on drafts, and providing midterm and final grades. Minimum requirement: Masters in English, Writing Studies, or related field; experience teaching first year writing. Guilford College does not discriminate on the basis of sex/gender, race, color, creed, religion, national origin, sexual orientation, gender identity, disability, genetic information, military status, veteran status, or any other protected category under applicable local, state or federal law, ordinance or regulation. See our full Statement of Non-Discrimination .

Posted 1 day ago

Lipscomb University logo
Lipscomb UniversityNashville, TN
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.

Posted 30+ days ago

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

Posted 2 weeks ago

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

Posted 2 weeks ago

T logo
Tutor Me EducationChino Hills, CA

$25 - $35 / hour

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.

Posted 2 days ago

Corcept Therapeutics logo
Corcept TherapeuticsRedwood City, CA

$144,800 - $212,900 / year

Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators. In 2012, we received FDA approval of Korlym (mifepristone), the first approved treatment for hypercortisolism (Cushing's syndrome). Today, our team and collaborators continue to unlock the possibilities of cortisol modulation as a way to treat serious diseases. With more than 30 ongoing studies across a wide range of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advancing the possibilities of cortisol modulation. What began as a ripple of scientific truth is now poised to unleash a sea change of discovery representing a fundamental shift in the way we understand and treat disease. The 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.

Posted 30+ days ago

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

Posted 2 weeks ago

Vertex Pharmaceuticals, Inc logo
Vertex Pharmaceuticals, IncBoston, MA

$20 - $35 / hour

Job Description Kickstart Your Career at Vertex! Are you ready to make a real impact? At Vertex, our mission is to tackle serious diseases and to change lives, for the better, for the future. Our aim is to give you the skills, insights, and career guidance to be an important part of that future; to turn your potential into progression. As a Vertex intern or co-op, you'll work on meaningful projects, collaborate with talented teams, and learn from industry leaders. We're passionate about innovation, inclusion, and supporting your growth-inside and outside the lab. Why Vertex? Real Projects: You'll work on assignments that make a real impact, not just busy work. Mentorship & Networking: Connect with leaders and peers who want to see you succeed through professional networks, connections, and collaborations that will shape your longer-term career. Flexible & Supportive: We offer flexible work options with Flex @ Vertex and prioritize your wellbeing. Inclusive Culture: Collaboration and inclusion are embedded in everything we do. Career Launchpad: Build skills, explore career paths, and get guidance for your future career. Ready to apply? Submit your application and let's turn possibilities into reality! Your Impact The Vertex Corporate Communications Scientific Writing Co-Op program is a 6-month experiential training program for students currently working towards undergraduate or advanced degree in Journalism, Communications, Marketing, or other related fields. If you are passionate, collaborative, and growth-minded, a co-op at Vertex will help you gain meaningful experience in our communications functional areas and serve as a launchpad for your career. Please note that Vertex reviews applications on a rolling basis and reserves the right to close this job posting prior to the listed deadline. Important Notice Regarding Internship and Co-op Inquiries At Vertex Pharmaceuticals, we are committed to providing a fair and structured recruitment process for all students interested in internship and co-op opportunities. To ensure consistency and equity, all student applications must go through our Early Talent Acquisition Team. Due to the high volume of interest, we are unable to respond to individual solicitation. Direct solicitation to Vertex employees- including senior leaders via email will result in removal from the recruiting process. We appreciate your enthusiasm and interest in Vertex. To be considered for internship or co-op roles, please apply directly through our official application channels. ( https://www.vrtx.com/careers/career-growth-and-opportunities/co-ops/ ) Thank you for respecting our process and helping us maintain a fair experience for all candidates. What you will be doing: The Co-op Corporate Communications- Scientific Writing and Disease Area Communications will gain valuable experience through supporting, and in some cases leading, several important communications projects across the disease areas in our research pipeline at Vertex. In pipeline communications, we work across the company to create both internal and external content about our disease and program areas, program announcements and research at Vertex. The selected candidate will work closely with project leads and other cross-functional team members on several defined projects, as well as provide general day-to-day support as needed. Potential duties will include: Writing and production of pipeline-related content for our employee intranet by researching, writing and packaging articles, patient and employee stories and multimedia content. Supporting disease affinity recognition throughout the year by writing internal and external content to educate our audiences and raise awareness for a given disease area Supporting the team and business partners by helping create and execute on communications plans for pipeline announcements and content campaigns (such as launching a video series) Supporting pipeline social media content channels with copy for disease recognition and pipeline-related conferences Compile metrics from communications campaigns and provide insight to help guide creation of strategy and planning for future initiatives. Provide support for ongoing communications initiatives and ad hoc projects, as needed What you will need to succeed: Enrolled in an undergraduate or graduate program in a Scientific Field, Journalism, Communications, Marketing, or another related field Outstanding written and verbal communication skills with excellent attention to detail Ability to succeed in a fast-paced environment with multiple, competing priorities Understanding of the scientific method and scientific concepts Prior internship experience in the medical/pharmaceutical/biotechnology industry, or in communications Ability to deliver results with limited direction and guidance on tight deadlines -- a self-starter Highly motivated and energetic Strong work ethic and tenacity Legal authorization to work in the United States, now and in the future. Please note that Vertex does not provide sponsorship for internships or entry level roles within this part of the organization. You must be enrolled in an advanced degree program if graduating before June 2026 You must be available to work full-time, 40 hours per week from January- June 2026 Program Details: Full-time, paid co-op $20.00 - 35.00 USD/hour Program Dates: January- June 2026 At Vertex, we believe that when you feel your best, you can perform at your best. That's why our US benefits and global well-being resources are designed to support you. Free 24/7 onsite gym access and free access to group exercise classes Subsidized commuter benefits- transit and parking Provided meals-free breakfast daily! Career development opportunities and events, including C Suite engagement Social events-both intern-only and company-wide Location-specific perks and extras! Recognition of National Intern Day Our Ways of Working Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: Hybrid: work remotely up to two days per week; or select On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. Equal Opportunities Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Vertex is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Accessibility & Accommodations We're focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Vertex is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant's ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role, Vertex is unable to sponsor non-U.S. persons to apply for an export control license. This job posting is for a temporary role with a third-party agency partner that provides services to Vertex. The individual selected for this role will be offered the role as an employee of that third-party agency; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency upon offer. Pay Range: $0 - $0 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

Posted 3 weeks ago

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

Posted 2 weeks ago

Ponca City Development Authority logo
Ponca City Development AuthorityKaw City, OK
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.

Posted 30+ days ago

Johnson & Johnson logo
Johnson & JohnsonIrvine, CA

$129,000 - $174,000 / year

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

Posted 1 week ago

University of Maryland Global Campus logo
University of Maryland Global CampusSan Diego, California

$17 - $19 / hour

Peer Tutor, Writing (On-Site) First Term Experience and Tutoring Services Student Affairs Non-Exempt, Contingent 1, Part-Time, Pay Grade Stateside Contingent Hourly Pay Rate: $16.50 (undergraduate) / $19 (graduate) Location: San Diego, CA University of Maryland Global Campus (UMGC) seeks accomplished UMGC students to work on-site as part-time peer tutors for UMGC graduate and undergraduate students at UMGC San Diego. Tutoring will be offered on-site at San Diego, CA via scheduled appointment and drop-in availability. Successful candidates will demonstrate high-level skills in both academic and technical writing and be able to support students in a variety of courses and programs. SPECIFIC RESPONSIBILITIES OF THE UMGC PEER TUTOR INCLUDE: Provide support as a UMGC student peer tutor to other students enrolled in UMGC course s Respond to students’ questions and concerns related to their UMGC assigned courses Respond to questions about course concepts related to assigned readings, projects, or written assignments Provide clarifications, examples, and tutorials that support the student in developing a writing process and authentic learning Promote a professional, respectful, and safe learning environment Work more closely with English language learners REQUIRED EDUCATION AND EXPERIENCE: In-depth knowledge in undergraduate writing skills, both academic and technical Excellent organizational, interpersonal, and verbal and written communication skills in English Ability to work closely with students to ensure student success Ability to work with diverse student populations PREFERRED EDUCATION AND EXPERIENCE: Letter of recommendation or referral from a faculty member in a WRTG course or another course in which writing assignments constituted the majority of graded assignments Background in teaching, tutoring, and/or other type of learning support experience initiatives in a face-to-face environment WHO WE ARE AND WHO WE SERVE UMGC—one of 11 degree-granting institutions in the University System of Maryland (USM)—is a mission-driven institution with seven core values that guide us in all we do. At the top of the list is "Students First," and we strive to do just that for our 90,000 students at home and abroad. From its start in 1947, UMGC has demonstrated its commitment to adult learners. We recognize that adult students need flexibility and options. UMGC is proud to be a global, 24-hour, institution of higher learning. The typical UMGC student is an adult learner juggling a career, family, and other priorities. Roughly 80% work full time, half are parents, and half are minority students. They are continuing their education to better themselves, their families, and their professional opportunities. UMGC is also a leading higher education provider to the U.S. military, enrolling 55,000 active-duty service members, reservists, National Guard members, veterans, and family members annually. We are proud of our military heritage and are committed to this service. POSITION AVAILABLE AND WILL REMAIN OPEN UNTIL FILLED All submissions should include a cover letter and resume . The University of Maryland Global Campus (UMGC) is an equal opportunity employer and complies with all applicable federal and state laws regarding nondiscrimination. UMGC is committed to a policy of equal opportunity for all persons and does not discriminate on the basis of race, color, national origin, age, marital status, sex, sexual orientation, gender identity, gender expression, disability, religion, ancestry, political affiliation or veteran status in employment, educational programs and activities, and admissions. Workplace Accommodations: The University of Maryland Global Campus Global Campus (UMGC) is committed to creating and maintaining a welcoming and inclusive working environment for people of all abilities. UMGC is dedicated to the principle that no qualified individual with a disability shall, based on disability, be excluded from participation in or be denied the benefits of the services, programs, or activities of the University, or be subjected to discrimination. For information about UMGC’s Reasonable Workplace Accommodation Policy or to request an accommodation, applicants/candidates can contact Employee Accommodations via email at employee-accommodations@umgc.edu . Benefits Package Highlights: Time Off: C1s that regularly work over 12 hours per week are eligible for limited sick and safe leave at the rate of 1 hour for every 30 hours worked, up to a maximum accrual of 40 hours in a calendar year. Health Coverage: Access to health care, medical with vision, dental, and prescription plans for both individuals and families, effective from the 1st of the month following your hire date. NOTE: CI employees are not eligible for the State of Maryland subsidized rates. CIs would be responsible for the total cost if enrolled. Insurance Options: Term Life Insurance, Accidental Death and Dismemberment Insurance. Supplemental Retirement Plans : include 401(k), 403(b), 457(b), and various Roth options. The university does not provide matching funds. Hiring Rate: $16.50

Posted 1 week ago

T logo
Tutor Me EducationPacifica, CA
At Tutor Me Education, we are revolutionizing the way students learn, and we're seeking passionate teachers and tutors with special education experience to provide 1:1 in-home tutoring in 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.

Posted 2 days ago

Vertex Pharmaceuticals logo

Principal Analyst, Clinical Operations/Medical Writing

Vertex PharmaceuticalsBoston, Massachusetts

$137,600 - $206,400 / year

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Job Description

Job Description

General Summary:

The Business Engagement & Technology Principal Analyst will be a technical resource in ensuring delivery and support of commercial-off-the-shelf (COTS) and a wide range of custom solutions in support of their business partners. The Business Engagement & Technology Principal Analyst will partner with business leadership to deliver capabilities and execute on a roadmap that align to support business strategy in Clinical Operations and Medical Writing . Additionally, the Business Engagement & Technology Principal Analyst will maintain reliable, scalable and compliant systems that easily meet business needs by efficient delivery and enhancements that provides opportunities for developing and implementing innovative solutions and integrations.

Key Duties and Responsibilities:

  • Become a trusted partner of the business leaders within their remit
  • Understand their needs and vision, and deliver technology solutions to support and enable their goals and objectives
  • Provide insights on how technology can improve business processes to enable operating efficiencies and support the achievement of business goals and objectives.
  • Help refine and execute the technology strategy by leading the evaluation, selection, implementation, and ongoing maintenance of technology solutions.
  • Develop and maintain a long term life cycle plan for the ongoing maintenance and management of systems.
  • Manage relationships with our strategic software vendors and service providers
  • Work closely with DTE Compliance, Internal Audit, and Quality Assurance groups as needed to ensure compliance with all appropriate regulations, as well as our DTE system lifecycle and change management requirements
  • Serve as a liaison between GMDA and Data, Technology & Engineering (DTE) to ensure strategic alignment.
  • Apply Agile, Lean, and design thinking methodologies to optimize solution delivery.
  • Translate complex data into actionable insights and compelling business narratives.
  • Monitor emerging technologies and trends to inform GMDA’s digital strategy.
  • Drive change enablement and foster a culture of agility and continuous improvement.

Knowledge and Skills:

  • In-depth knowledge in the core disciplines of project management, business analysis, solution design, delivery, and testing
  • Experienced in building productive partnerships with business stakeholders and aligning them around a recommendation/solution
  • Strong understanding of the business (Clinical Operations/Medical Writing), processes, and any appropriate regulatory environments
  • Expertise in data analytics tools (e.g., Tableau, Power BI, SQL) and enterprise platforms in the Clinical Operations space (e.g., Veeva, Suvoda, Salesforce).
  • Deep understanding of GMDA functions including clinical development, regulatory affairs, and medical affairs.
  • Results oriented contributor with a proven track record of on-time project delivery for large, complex projects with global stakeholders
  • Able to manage own workload with minimal direction
  • Very strong written and verbal communication skills and strong ability to present complex or sensitive information in a clear and concise manner to various technical and non-technical audiences
  • Exceptional analytical, quantitative, problem-solving, and prioritization skills
  • Strong system life cycle expertise
  • Good knowledge of running IT managed services or outsourced/ offshore teams
  • Exceptional communication and stakeholder engagement skills.
  • Very strong MS Office skills, including MS Project & Visio, Excel and PowerPoint experience
  • Experience in Agile methodology
  • Ability to influence strategic decisions and drive alignment across diverse teams.

Education and Experience:

  • Bachelor’s degree in Information Technology, Business Administration, Life Sciences, or related field; advanced degree preferred.
  • Minimum of 8 years of experience in business engagement, technology strategy, or data analytics within the pharmaceutical or biotechnology industry.
  • PMP or equivalent project management certification preferred.
  • Experience with AI/ML applications and digital transformation initiatives is a plus.

Pay Range:

$137,600 - $206,400

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations.  From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Flex Designation:

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as: 1.    Hybrid: work remotely up to two days per week; or select2.    On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. 

#LI-Hybrid

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

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