- Develop budget and resource strategies to ensure on schedule completion of medical writing deliverables, including the identification, selection, and oversight of qualified full- or part-time medical writers, vendors, consultants, or contractors
- Lead writing strategy, drive document content and organization, develop and manage timelines, and identify relevant stakeholders. Collaborate with subject matter experts on document development and review
- Independently author or manage others in the preparation of clear and concise clinical, nonclinical and regulatory documents and ensure consistency of messaging/content across all documents supporting regulatory submissions
- Responsible for ensuring the accuracy and quality of submission-ready documents using established and effective writing processes
- Advanced degree - PhD, PharmD, MS or equivalent
- Minimum of 10 years of relevant medical/regulatory writing experience in the pharmaceutical industry required, or in a related area such as regulatory, clinical research, or product support/R&D
- Minimum of 5 years of regulatory document project management experience with extensive experience in working with collaborative, cross-functional teams
- Demonstrated experience mentoring medical writers, managing project work, and supervising internal and external writers/vendors
- Demonstrated track record of contribution to successful regulatory components used in filings e.g., IND/CTAs, NDA/BLA/MAAs
- Working knowledge of drug development, clinical research, study design, biostatistics, regulatory, and medical terminology
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Associate Director, Medical Writing
2 weeks ago
Assembly Biosciences, Inc. South San Francisco, United StatesJob Description · Job DescriptionSalary: $144,000 - $160,000 · Position Title: Associate Director, Medical Writing · Reports to: Senior Director, Regulatory Affairs · Status: Regular, Full-time, Exempt · Summary: We are seeking a highly motivated Associate Director, Medical Writ ...
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Director / Senior Director, Medical Writing
3 weeks ago
Annexon, Inc. Brisbane, United StatesDirector / Senior Director, Medical Writing · Work Location · Corporate Headquarters (South San Francisco, CA) - Hybrid · Position Summary · The Director / Senior Director, Medical and Scientific Writing plays a critical role. Reporting to the SVP, Regulatory, Quality and Pharmac ...
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Director / Senior Director, Medical Writing
3 days ago
BioSpace South San Francisco, United StatesJob Details · Work Location · Corporate Headquarters (South San Francisco, CA) - Hybrid · Position Summary · The Director / Senior Director, Medical and Scientific Writing plays a critical role. Reporting to the SVP, Regulatory, Quality and Pharmacovigilance, you will work in p ...
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Director, Medical Writing
1 week ago
Corcept Therapeutics Menlo Park, CA, United StatesCorcept 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 approva ...
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Director, Medical Writing
2 weeks ago
Gilead Sciences, Inc. Foster City, United States Full timeDirector, Medical Writing · United States – Remote · Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, w ...
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BeiGene Emeryville, United States**General Description:** · **Responsible for leading clinical regulatory medical writing activities for BeiGene that conform to domestic and/or international regulatory submission and internal document standards. Clinical regulatory documents include, but are not limited to, cli ...
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Director / Senior Director, Medical Writing
1 month ago
Annexon, Inc. South San Francisco, United States Full timeWork Location · Corporate Headquarters (South San Francisco, CA) – Hybrid · Position Summary · The Director / Senior Director, Medical and Scientific Writing plays a critical role. Reporting to the SVP, Regulatory, Quality and Pharmacovigilance, you will work in partnership with ...
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Medical Writing Technology Lead
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Ethos Veterinary Health Redwood City, CA, United States Full timeClinical Lead, Veterinary ER/CCU - Overnight Shift, SAGE Redwood City · Ethos is the new, industry-leading community of legacy Ethos Veterinary Health , Compassion-First, SAGE Veterinary Centers , and legacy NVA Specialty and Emergency hospitals. This powerful new community brin ...
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BeiGene San Mateo, United States**General Description:** · **Responsible for leading clinical regulatory medical writing activities for BeiGene that conform to domestic and/or international regulatory submission and internal document standards. Clinical regulatory documents include, but are not limited to, clin ...
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Senior Associate Attorney
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AGG Legal Staffing San Francisco, United StatesSeeking a California licensed Senior Associate Litigation Attorney with 5 to 7 years of experience for a boutique law firm specializing in toxic tort and asbestos litigation to join the trial team covering all aspects of litigation and to be a team leader to junior associates. · ...
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FDA Regulatory Associate Attorney
1 week ago
WFB Perkins Coie LLP San Francisco, United States Full timeJob Description: · To apply, please attach your cover letter, resume, law school transcript, and a writing sample. · This position is eligible for an annual discretionary bonus, 401(k) plan, medical, dental, and vision insurance, personal medical and parental leave, up to ten pa ...
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FDA Regulatory Associate Attorney
3 weeks ago
WFB Perkins Coie LLP San Francisco, United States Full timeJob Description: · To apply, please attach your cover letter, resume, law school transcript, and a writing sample. Principals only. · This position is eligible for an annual discretionary bonus, 401(k) plan, medical, dental, and vision insurance, personal medical and parental lea ...
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BQuant Technical Writer
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Mediabistro San Francisco, United StatesFinance is changing, and fast: new financial professionals are learning to code with Python and create their own custom analytical solutions. Bloomberg, the global leader in business and financial data, has identified an exciting new opportunity to reach this tech-savvy client ba ...
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Nurse Practitioner
3 weeks ago
Dignity Health San Francisco, United StatesOverview · St. Marys Medical Center has been caring for the health of San Franciscans since 1857 when it was founded by eight Sisters of Mercy from Ireland. It is an accredited not-for-profit hospital located across the street from Golden Gate Park. It is a full-service acute car ...
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Senior Litigation Attorney
2 weeks ago
Snappyhires San Francisco, United StatesJob Description:- · In this Senior Litigation Associate role, you will provide legal advice and guidance to our clients, work closely with our team of attorneys and support staff, and take a leadership role in developing litigation strategies. · What You'll Bring to the Table: · ...
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Radar Algorithms Expert
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BHO Tech San Francisco, United States Full timeWe're the driverless car company. We're building the world's best autonomous vehicles to safely connect people to the places, things, and experiences they care about. · Our vehicles are on the road in California, Arizona, and Michigan navigating some of the most challenging and u ...
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Senior Litigation Associate
2 days ago
SalesBountyHunter San Francisco, United StatesOur client is seeking a Senior trial attorney to join their team. They are a national law firm specializing in plaintiff's litigation and personal injury. · In this Senior Litigation Associate role, you will provide legal advice and guidance to our clients, work closely with our ...
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Kokkinaki/Evbuomwan Research Assistant
3 weeks ago
University Of San Francisco San Francisco, United States Part timeDescription · This position is for an undergraduate research assistant for Spring and Summer of 2023. The research project is focusing on the behavior of a class of contaminants, called PFAS, in aquatic and soil environments. This project will a variety of research skills, namel ...
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Health Education Manager
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North East Medical Services San Francisco, United StatesThe Health Education Manager is responsible for the overall management and supervision of health education programs and services. S/he will also represent NEMS in community education/ outreach activities and counseling patients in a variety of settings. · ESSENTIAL JOB FUNCTIONS: ...
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Litigation Associate
1 week ago
Manatt, Phelps & Phillips, LLP Silicon Valley, United States Full timeBrief Description · Manatt, Phelps & Phillips, LLP, is seeking highly qualified associates with a minimum of three years of litigation experience to join our high-profile litigation practice. · Our Trial, White Collar and Investigations Business Unit boasts a diverse practice enc ...
Head of Medical Writing - San Francisco, United States - Barrington James
Description
Head of Medical Writing - Rare disease Biotech
We are currently partnered with a growing, west coast based biotech focused on developing rare orphan diseases looking to hire a Head of Medical Writing to lead the division.
Reporting directly into an exceptional SVP, Clinical Development, you'll be responsible for overseeing the currently medical writing group in charge of delivering regulatory and clinical submissions.
Qualifications:
Interviews are currently underway with the client looking to make the hire by the end of Q2
If interested, please apply or email
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