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
- Enigma Search is looking for an Associate Director, Medical Writing, to oversee the development of clinical and regulatory documentation. The ideal candidate will have an advanced degree in life sciences and over 8 years of medical writing experience in biotech or pharmaceutical...SeniorMedicalRegulatory
- Itlearn360 is seeking a Senior Medical Writer in South San Francisco. This role involves... ...high-quality documents for clinical trials and regulatory submissions. The ideal candidate should have 8-10 years of scientific writing experience, including expertise in neuromuscular...SeniorMedicalRegulatoryRemote jobHourly payTemporary work
- Enigma Search is looking for an Associate Director, Medical Writing in South San Francisco, California. This role involves leading the development of clinical and regulatory documentation, ensuring compliance with global standards, and managing the writing process. The...MedicalRegulatory
$270k - $360k
...Medical Director/Senior Medical Director, Clinical Development TenvieTherapeutics is developing precision... ...‑on Medical Director to lead early‑ and mid‑stage... ...‑quality clinical and regulatory documentation Lead or oversee... ...scientific and medical writing skills; able to produce...SeniorMedicalRegulatoryLocal areaRemote work$125k - $180k
Clinical Development Scientist/Senior Clinical Development Scientist TenvieTherapeuticsis... ...Science, and Regulatory to ensure high‑... ...indication prioritization Lead or co‑lead the... ...in ongoing medical and scientific data... ...Excellent scientific writing skills with a track...SeniorMedicalRegulatoryInterim roleLocal areaRemote work$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). uthor key... ...-ready manner. Support Lead Clinical Programmers in developing and... ...Managers, Programming, and Regulatory teams. Review study protocols... ...skills, with experience writing Data Management Plans, Data...SeniorMedicalRegulatory
$117k - $184.2k
Job Description The Early Clinical Scientist (ECS) coordinates the... ...knowledge of GCP, ICH guidelines and regulatory requirements for clinical... ...of new procedures. Technical Writing & Communications Co-authors... ...site training/monitoring; medical and regulatory writing Required...SeniorMedicalRegulatoryFull timeFor contractorsLocal areaWorldwideRelocationVisa sponsorshipFlexible hoursShift work$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$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... ...comparable credentials. Benefits Medical, dental, and vision plans...SeniorMedicalRegulatoryRemote workWork from homeFlexible hours$135k - $150k
...peptide drugs. We are advancing a clinical‑stage pipeline of... ...program goals. Supports the Study Lead as an integral member of a... ...amendments, and works with medical writing to initiate protocol amendments... ...and study drug, safety, regulatory, and legal questions. Contributes...SeniorMedicalRegulatoryContract workWork at officeRemote work- ...Brisbane, California, is seeking a Sr. Director, Head of Regulatory & Medical Writing to lead the regulatory writing efforts for key project... ...involves collaborating with cross-functional teams to produce clinical documents, managing internal and external writing resources...SeniorMedicalRegulatory
- ...breaches. About the Role The Senior Workplace Investigations Business Partner leads complex, employee‑... ...is heightened legal, regulatory, or reputational exposure... ...skills; expert at writing clear, concise investigative... ...off and sick leave, medical/dental/vision benefits,...SeniorMedicalRegulatoryHourly payWork at officeLocal areaFlexible hours
- ...South San Francisco, CA is seeking a Senior Director, Clinical Data Management to lead data management programs, define... ..., and oversee EDC builds for regulatory milestones. You will manage CROs,... ...Clinical Operations, Biostatistics and Medical Directors, and help build data...SeniorMedicalRegulatory
- IDEAYA Biosciences, Inc. in South San Francisco is looking for a Senior Director, Medical Writing to lead the strategy and development of clinical and regulatory documents across oncology programs. This role entails overseeing a medical writing team and managing projects...MedicalRegulatory
$261k - $304.5k
## Senior Director, CMC Lead Product DevelopmentApplylocations: South San Francisco... ...program(s) across the clinical development life-cycle and... ...supply chain, CMC, quality, regulatory, program & portfolio management... ...possess good scientific writing skills and good verbal skills...SeniorRegulatory- ...seeks an experienced Senior Clinical Scientist to advance pre... ...integrity to ensure regulatory compliance. The incumbent... ...closely with the medical monitor, operations team... ...trial management Reports: write study reports, plans,... ...success in leading cross-functional teams...SeniorMedicalRegulatoryLocal area
$115k - $121k
...leveraging its strengths to address unmet medical needs. We are looking for exceptional... ...a rapidly growing biotech. Position: Senior Clinical Research Associate Opportunity Epicrispr... ...studies are conducted in compliance with regulatory requirements, GCP guidelines, and...SeniorMedicalRegulatoryLocal area- ...Early Clinical Scientist Translational Medicine... ...GCP, ICH, and regulatory requirements,... ...development teams. Leads the development of... ...results. Technical Writing & Communications... ...escalation and mitigation, senior management... ...training/monitoring; medical and regulatory...MedicalRegulatoryWorldwide
- ...motivated, well‑organized, and skilled Senior Director, Medical Writing to provide strategic and operational... ...Project Management. What You’ll Do Lead authoring strategy and oversee the successful development of clinical and regulatory documents (e.g., INDs, NDAs, BLAs,...SeniorMedicalRegulatoryTemporary workFor contractorsLocal area
- A clinical quality assurance organization is seeking a Senior Manager, Clinical Quality Assurance in South San Francisco. In... ...will drive quality oversight and regulatory readiness of clinical studies,... ...essential GCP standards. You will lead audits, provide mentorship, and...SeniorRegulatory
$245k - $302k
...of disease and improving clinical outcomes for patients with... ...well‑organized, and skilled Senior Director, Medical Writing to provide strategic and... ...for delivering high‑quality regulatory and clinical documents... ...Management What you’ll do Lead authoring strategy and oversee...SeniorMedicalRegulatoryTemporary workFor contractorsWork at office$336k - $374k
...advancing a late-stage clinical platform of novel... ...integrity, regulatory compliance, and alignment... ...functional teams, lead regulatory... ...regulatory affairs, medical affairs, pharmacovigilance... ...teams at a senior or executive level... ...Experience in HA meetings, writing briefing books,...SeniorMedicalRegulatoryRemote workFlexible hours$225k - $330k
...drugs. We are advancing a clinical‑stage pipeline of... ...analyses, interpretations, regulatory submissions (NDA, MAA... ...with colleagues (Medical, Statistical Programmers... ...Data Management, Medical Writing, Safety, Clinical... ...specifications Coordinate and lead team review and...SeniorMedicalRegulatoryWorldwide$141.7k - $263.1k
Senior Manager, Product Public Relations Why... ...& Access, U.S. Medical Affairs, cross‑functional... ...) around data and regulatory milestones and... ...understanding of clinical data and regulatory... .... Outstanding writing skills and proven... ...Significant experience in leading issues...SeniorMedicalRegulatoryLocal areaRelocation package- ...development support for clinical plans and individual study protocols Writes or assists in writing of... ...Brochures, DSURs and other regulatory documents Assist other... ...of trial Assist in Medical Monitor responsibilities... ...of other personnel (team lead) Qualifications and Education...MedicalRegulatoryWork at officeImmediate start
$257k - $286k
Annexon Biosciences, located in Brisbane, California, is seeking a Senior Director, Medical and Scientific Writing. In this role, you will collaborate with clinical, regulatory, and medical teams to develop key documents for our clinical programs. A minimum of 10 years...SeniorMedicalRegulatoryRemote job- Veeva Systems seeks a Principal Medical Writing Domain Expert for Veeva Falcon to design an AI-enabled regulatory authoring platform. You will... ...teams to automate primary clinical documents with precision, while... ...global assets. You will lead as a subject matter expert during...MedicalRegulatory
- ...today and address the medical challenges of... ...modalities, to human clinical studies and... ...highly motivated Senior Scientist II to join... ...this role, you will lead laboratory‑based scale... ..., and regulatory support documents.... ...including technical writing and scientific data...SeniorMedicalRegulatory
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Medical Writing Lead for Clinical & Regulatory. Be the first to apply!
- senior magento developer South San Francisco, CA
- sr marketing manager South San Francisco, CA
- sr technical product manager South San Francisco, CA
- senior manager pmo South San Francisco, CA
- senior accountant part time South San Francisco, CA
- senior application support engineer South San Francisco, CA
- sr industrial engineer South San Francisco, CA
- senior tax South San Francisco, CA
- senior director digital marketing South San Francisco, CA
- senior manager legal South San Francisco, CA

