Senior Nonclinical Medical Writer — Regulatory Submissions
MSD
Merck & Co., Inc. in California seeks an experienced Medical Writer to join our Nonclinical Pharmacology Documentation group, managing multiple preclinical programs and regulatory modules. You will collaborate with research and regulatory teams to produce high-quality scientific and regulatory documents enabling development milestones. The role requires strong scientific writing, experience with CTD modules, and project management in a fast-paced setting, with hybrid work options and a focus on #J-18808-Ljbffr MSD
- Merck & Co., Inc. seeks an experienced Medical Writer to join the Nonclinical Pharmacology Documentation group. You will generate preclinical reports and regulatory submission modules, partnering with research and regulatory teams to ensure high-quality scientific and...SeniorRegulatory
$171k - $223k
...Toxicologist with over 10 years of industry experience to lead nonclinical safety strategies across discovery and development stages.... ...involves mentoring junior scientists, providing input on regulatory submissions, and developing innovative toxicology processes. We offer...SeniorRegulatory- Position Title: Senior Medical Content Writer Work Location: South San Francisco, CA Assignment Duration... ...packages ready for MLR submission. Write medical content across formats... .... Partner with medical affairs and regulatory reviewers to resolve claim language...SeniorRegulatoryWork at officeMonday to Friday
- The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) leads initiatives to develop and manage regulatory strategies for CMC submissions, including INDs/CTAs and amendments. This role builds relationships across Regulatory Affairs, Operations...SeniorRegulatory
- Marea Therapeutics, based in South San Francisco, seeks a Senior Manager, Regulatory Affairs to lead regulatory planning and tactical... ...coordinating with internal teams and external partners to drive submissions and regulatory strategy. The ideal candidate has >8 years...SeniorRegulatory
- ...oversee project management of drug development processes. Responsibilities include leading cross-functional teams, managing regulatory submissions, and ensuring projects meet business needs. Ideal candidates will possess strong leadership, project management skills, and...SeniorRegulatory
- Veratherapeuticsinc seeks a Senior Manager, Regulatory CMC to manage regulatory submissions and activities within a dynamic team. This role requires strong regulatory... ...bonuses, equity options, and comprehensive medical benefits. #J-18808-Ljbffr VeratherapeuticsincSeniorRegulatory
- ...Francisco seeks an Associate Director in Toxicology to lead nonclinical safety strategies for multiple programs. You will play a key... ...influencing program decisions that ensure patient safety and regulatory success. The ideal candidate holds a PhD with 10+ years of experience...SeniorRegulatory
$131.4k - $206.8k
...Description We are seeking an experienced Medical Writer to join our Nonclinical Pharmacology Documentation group... ...of preclinical reports and submission modules to support development programs... ...partner with various research and regulatory functions to prepare high-quality...SeniorRegulatoryFor contractorsWork at officeLocal area- ...~30 hours/week) to manage a variety of writing and editing projects, including Clinical Study Protocols, amendments, CSRs, regulatory submissions and DSUR responses. The role requires extensive experience in clinical/regulatory writing within biotech, strong communication...RegulatoryRemote jobContract workPart timeFor contractors
- Denali Therapeutics Inc is seeking an experienced Regulatory Project Manager to drive the regulatory... ...programs. You will partner with Regulatory Affairs, Medical Writing, Operations, and development SMEs to ensure submissions stay on track and aligned with program goals....SeniorRegulatory
- Spectraforce Technologies is seeking a Senior Medical Content Writer in South San Francisco, CA. The role is hybrid (Tue-Wed-Thu in office) with... ...biotech, deep MLR familiarity, and expertise in AMA style and regulatory guidelines. Strong collaboration with medical affairs is...SeniorRegulatoryWork at office
- YO AI Labs seeks an experienced Medical Writer Expert for remote contract work. You will develop, review, and evaluate clinical and regulatory documents with a focus on accuracy, regulatory compliance, and quality. This role requires deep expertise in CSRs, ICH guidelines...SeniorRegulatoryRemote jobContract work
- BridgeBio seeks a Senior Manager / Associate Director, CMC Regulatory Sciences in the San Francisco area for a hybrid role. The candidate will collaborate... ...design control strategies, author and review regulatory submissions, and respond to health authority queries to support...SeniorRegulatory
- Pharmatech Associates, Inc. in San Francisco, CA seeks a senior Regulatory Affairs professional to lead development of regulatory strategies... .... You will manage ANDA preparation, review, and submission processes, and serve as the primary contact with the US FDA,...SeniorRegulatoryRemote job
- ...Officer, we are hiring a Director, CMC Regulatory Affairs to join our Technical Operations... ..., regulatory operations, quality, CMC, nonclinical and clinical departments.... ...and manage all CMC aspects of regulatory submissions, including strategy for updating existing...SeniorRegulatory
- Penfield Search Partners Ltd is seeking a Senior Regulatory Submission Lead to drive a BLA submission across Module 2 and Module 5 for a Bay Area-based project. This 1-year contract role emphasizes hands-on submission execution, cross-functional coordination, and regulatory...SeniorRegulatoryContract work
$120 - $175 per hour
...penfieldsearch.comNo 3rd party candidatesLocation: Bay Area-based roleWork Model: 5 days onsite per weekWe are seeking a Senior Regulatory Submission Lead to support a critical BLA submission across Module 2 and Module 5. This 1 year contract role will provide hands-on...SeniorRegulatoryHourly payContract work$131.4k - $206.8k
...We are seeking an experienced Medical Writer to join our Nonclinical Pharmacology Documentation group responsible... ...of preclinical reports and submission modules to support development programs... ...partner with various research and regulatory functions to prepare high-quality...SeniorRegulatoryFull timeFor contractorsWork at officeLocal areaRelocationVisa sponsorshipFlexible hoursShift work$254.13k - $289.39k
...responsible for providing regulatory writing expertise and... ...documents for submission. The Sr. Director, Head of Regulatory & Medical Writing will be responsible... ...contractors and internal writers) assigned to... ...summary reports Clinical, Nonclinical and Multidisciplinary...SeniorRegulatoryOdd jobFor contractorsFlexible hoursShift work$125k - $180k
...Development Scientist/Senior Clinical Development Scientist... ...Science, and Regulatory to ensure high‑quality... ...and outcomes Integrate nonclinical, translational, and clinical... ...in ongoing medical and scientific data review... ...involvement in regulatory submissions (e.g., IND/CTA,...SeniorRegulatoryInterim roleLocal areaRemote work- ...Summary:This position provides international regulatory leadership and is primarily responsible... ...approvals and registrations for medical devices outside the United States. The... ...international regulatory strategies, manages submissions and post-approval activities,...SeniorRegulatory
$194.1k - $305.6k
...and highly collaborative Senior Principal Scientist to... ...dose projection, and regulatory packages. Provide scientific... ...scientific documents, nonclinical packages as part of regulatory submissions, project updates, and... ...benefits include medical, dental, vision healthcare...SeniorRegulatoryFull timeContract workFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$230k - $245k
...Principal Medical Writer Mirum Pharmaceuticals is a biopharmaceutical company dedicated... ...writing service providers to develop Regulatory documents, including but not limited to... ...narratives, clinical development plans, IND submissions, integrated summary reports, NDA/MAA...RegulatoryLocal area- ...high-quality, fit-for-purpose clinical and regulatory documents to facilitate speed of information during development, submission, approval, and life-cycle management of products... ...across companies (eg, meetings of DIA and medical writing communities)with guidance from line...RegulatoryFull timeFor contractors
- Nurix Therapeutics, Inc. invites an experienced Director/Senior Director of Regulatory Affairs (Strategy, Oncology - Solid Tumors) to join the Regulatory... ...the global regulatory strategy, guide high-quality submissions, and work with cross-functional partners to enable timely...SeniorRegulatory
$337.5k - $412.5k
...Senior Medical Director South San Francisco, CA The Position... ...Author and review clinical-regulatory documents, including protocols... ...with project management, CMC, nonclinical development, regulatory... ...Experience with the preparation and submission of scientific publications,...SeniorRegulatory3 days per week- Marea Therapeutics in South San Francisco is seeking a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to lead regulatory... ...with hands‑on execution to drive CMC development and submissions, including device-related #J-18808-Ljbffr Marea TherapeuticsSeniorRegulatoryFull time
$270k - $360k
...Medical Director/Senior Medical Director, Clinical Development Tenvie... ...related franchises Integrate nonclinical, translational, and... ...high‑quality clinical and regulatory documentation Lead or oversee... ...sections of regulatory submissions (e.g., IND/CTA, briefing packages...SeniorRegulatoryFull timeLocal areaRemote work- Nurix Therapeutics, Inc. is seeking a Director/ Senior Director of Regulatory Affairs (Strategy, Oncology - Solid Tumors) to develop and execute global regulatory strategy and lead high-quality submissions. You will partner with SVP Regulatory Affairs and cross-functional...SeniorRegulatory
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