Senior Medical Writing Lead for Clinical & Regulatory
Calico LLC
A biotech research company in South San Francisco seeks an Associate Director of Medical Writing to lead the development of high-quality clinical and regulatory documents. The ideal candidate must possess a Master's degree and over 8 years of experience in scientific writing at a biotech or pharmaceutical company. Responsibilities include document leadership, vendor management, and process improvement. A strong understanding of regulatory requirements and excellent communication skills are essential. The estimated salary range is $230,000 - $240,000 with additional bonuses. #J-18808-Ljbffr Calico LLC
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$117k - $184.2k
...Early Clinical Scientist (ECS) coordinates the design, planning, and... .... Applies GCP, ICH, and regulatory requirements. Represents Early... ...promotes best practices. Technical writing: Co-authors protocols,... ...execution; site training/monitoring; medical/regulatory writing). Required...SeniorMedicalRegulatory- ...Pharmaceuticals Inc. is seeking a senior leader to integrate translational medicine, clinical pharmacology, and biomarker... ...decisions, reporting to the Chief Medical Officer. The role combines... ...activities through development and regulatory submissions, with a focus on...SeniorMedicalRegulatory
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...Clinical Development Scientist/Senior Clinical Development Scientist TenvieTherapeuticsis... ...Science, and Regulatory to ensure high‑... ...indication prioritization Lead or co‑lead the... ...Participate in ongoing medical and scientific data... ...scientific writing skills with a track...SeniorMedicalRegulatoryInterim roleLocal areaRemote work- Zai Lab is seeking a Senior Medical Director for Oncology Clinical Development to lead late-stage programs, including pivotal Phase III trials and regulatory submissions. The role requires medical leadership, cross-functional collaboration, and external representation...SeniorMedicalRegulatoryWork at office
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Structure Therapeutics in South San Francisco seeks an Associate Director of Medical Writing. The role includes leading the development of regulatory documents and performing quality control reviews to ensure compliance. The ideal candidate will have over 5 years of experience...SeniorMedicalRegulatory- ...curable and no longer the leading cause of death in the world... ..., Early Development, the Senior Director, Clinical Pharmacology will provide... ...stage development, supporting regulatory submissions, and serving... ..., Regulatory Affairs, Medical Writing, CMC, Research, and other...SeniorMedicalRegulatory
- Nurix Therapeutics is seeking a Sr. Director, Head of Regulatory & Medical Writing to lead the medical writing group and shape the strategy for key regulatory... ...and high-quality deliverables, and collaborate with Clinical Science and Regulatory teams across oncology programs....SeniorMedicalRegulatoryContract work
$270k - $360k
...Medical Director/Senior Medical Director, Clinical Development Tenvie Therapeutics is developing... ...seeking a Medical Director to lead early- and mid-stage... ...oversight, and support regulatory submissions partnering... ...scientific and medical writing skills; able to produce...SeniorMedicalRegulatoryFull timeLocal areaRemote work- Merck in South San Francisco, CA, seeks a Senior Director, Clinical Science - Hematology to lead strategic Clinical Science across the hematology... ..., partner with Clinical Operations, Regulatory Affairs, Biostatistics, and Medical Affairs, and travel up to 25% to advance programs...SeniorMedicalRegulatory
- Merck & Co. is seeking an experienced Medical Writer to join the Nonclinical Pharmacology Documentation group. The role focuses on generating... ...development programs, with collaboration across research and regulatory functions. The successful candidate will manage multiple...SeniorMedicalRegulatory
- 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 regulatory...SeniorMedicalRegulatory
$125k - $180k
...Clinical Scientist/Senior Clinical Scientist Tenvie Therapeutics... ...Translational Science, and Regulatory to ensure high‑... ...RESPONSIBILITIES: Lead development of core clinical... ...training material, medical monitoring plans,... ...Excellent scientific writing skills with a track record...SeniorMedicalRegulatoryFull timeLocal areaRemote work$170k - $200k
...and highly motivated Senior Clinical Scientist to join our... ...need, scientific data, regulatory landscape, and expertise... ...including Clinical, Medical, Clinical Operations,... ...teamwork; ability to lead team activities Proficient... ...and medical writing skills Knowledge of or...SeniorMedicalRegulatoryWork at officeShift work2 days per week3 days per week$360k - $420k
...protein degraders to the clinic. Lycia is headquartered... ...in providing medical leadership and expertise... ...Primary Responsibilities Lead the development, execution... ...clinical development and/or regulatory approval. Provide... ..., NDA). Experience in writing clinical sections of regulatory...SeniorMedicalRegulatoryContract workFlexible hours$260k - $275k
...Summary Reporting to the VP, Clinical Operations, the Senior Director, Clinical Data... ...support decision milestones and regulatory requirements. The... ...Operations, Biostatistics, and Medical Directors, to support... ...often still be involved in writing DMPs (Data Management Plans...SeniorMedicalRegulatoryTemporary workWork at officeLocal area2 days per week3 days per week- ...Central Reading Centers, Labs, Medical Coders). Author key... ...audit-ready manner. Support Lead Clinical Programmers in developing and... ...Managers, Programming, and Regulatory teams. Review study protocols... ...documentation skills, with experience writing Data Management Plans, Data...SeniorMedicalRegulatory
$276k - $341k
...disease and improving clinical outcomes for... ...motivated, outgoing Senior Director of Clinical... ...leader providing medical-scientific... ...clinical leader, writing clinical development... ...investigator brochures and leading the team that... ...clinical operations, regulatory affairs,...SeniorMedicalRegulatoryContract workTemporary workWork at officeLocal areaWork from home$306.1k - $382.6k
...Position Summary Join Acadia as a Senior Director, Clinical Development and play a key... ...provide scientific and medical leadership across clinical... ..., study execution, and regulatory interactions. You will partner... ...monitoring, data analysis and writing of final reports Maintain...SeniorMedicalRegulatoryWork at officeLocal areaRemote workNight shift3 days per week$346k - $397k
...Medicines is a late‑stage clinical oncology company... ...developer to serve as Senior Medical Director of Clinical Development... ...role you will lead the clinical science aspects... ...with scientific, regulatory, and commercial teams... ...trial design, protocol writing, CRF construction, and...SeniorMedicalRegulatory- ...Corvus Pharmaceuticals is a clinical and late-stage... ...diseases and cancer. Our lead program, soquelitinib,... ...individual study protocols Writes or assists in writing... ..., DSURs and other regulatory documents Assist other... ...of trial Assist in Medical Monitor responsibilities...SeniorMedicalRegulatoryWork at officeImmediate start
- ...Senior Clinical Scientist Job Title: Senior Clinical Scientist... ...critical unmet medical needs. We're looking for... ...Science, Data Science, Regulatory and Quality teams, to... ...intraoperative FIH study. Lead study strategy,... ...Excellent scientific writing, critical-thinking, and...SeniorMedicalRegulatoryFull timeFlexible hours
$299k - $349k
...biopharmaceutical company in California is seeking a Senior Medical Director to lead late-stage clinical development programs in Oncology. This role... ...collaboration with cross-functional teams to ensure regulatory compliance. The pay range is between $299K and $349...SeniorMedicalRegulatory$135k - $145k
...peptide drugs. We are advancing a clinical‐stage pipeline of... ...program goals.Supports the Study Lead as an integral member of a multifunctional... ...amendments, and works with medical writing to initiate protocol... ...and study drug, safety, regulatory, and legal questions....SeniorMedicalRegulatoryContract workWork at officeRemote work- Scorpion Therapeutics in South San Francisco is seeking a Senior Clinical Data Manager Lead to guide data collection, standardization, and quality... ...ensuring compliance with ICH/FDA, CDISC standards, and regulatory expectations. This role requires strategic problem-solving...SeniorRegulatory
$121k - $185k
...and compliance story. As our Senior GRC Security Lead, you will be the architect... ...aligned with evolving regulatory requirements, industry frameworks... ...policy and standards writing ability - capable of translating... ...Gongsters a variety of medical, dental, and vision plans,...SeniorMedicalRegulatoryRemote workWork from homeFlexible hours
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