Head of Medical Writing, Oncology Regulatory Strategy
BioSpace
IDEAYA Biosciences is a precision medicine oncology company focused on transforming therapies for cancer. The Senior Director, Medical Writing leads strategic and operational efforts to deliver regulatory and clinical documents for global development and registration. The role requires an advanced life sciences degree and 10–12 years of medical-writing experience, including 5+ years in leadership, with a track record supporting INDs and major oncology submissions. #J-18808-Ljbffr BioSpace
- 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
$320k - $350k
...to catalyze and enable medical breakthroughs.Position... ...discovery efforts as Head of Peptide Drug Discovery... ...Contribute to global regulatory submissions (e.g., IBs... ...challenges and pivot strategies in a fast-paced... ...oral communication and writing skills, with record-keeping...MedicalRegulatory$245k - $302k
...Therapeutics, Inc. is seeking a Senior Director of Medical Writing in South San Francisco. The ideal candidate will provide leadership on regulatory documents and oversee a team, requiring an extensive background in oncology and successful IND submissions. Competitive...MedicalRegulatory- Job Description Manages other Medical and/or Scientific Directors and leads the direction... ...overall product scientific and business strategy. Personally or through a direct report,... ...principles, knowledge of compliance and regulatory requirements, AbbVie’s customers,...MedicalRegulatoryLocal area
$146.54k - $189.64k
...medicines in areas of unmet medical need including virology, oncology, and inflammation. With... ...around the world.Gilead Regulatory Affairs is a committed and... ...we do. The Content Strategy & Development (CSD) department... ...document strategy for Medical Writing.Key Responsibilities...MedicalRegulatoryFull timeFor contractorsWork at officeLocal area- ...senior leader within Oncology Clinical Development responsible... ...(Thoracic, Lung, Head & Neck, and... ...patient focus, quality, and regulatory readiness while driving... ...Translational Medicine, Medical Affairs, and other key... ...oncology development strategies. Key Responsibilities...MedicalRegulatoryImmediate start
- Maze Therapeutics is seeking a senior regulatory medical writer to lead the function across development programs. You will develop high-quality... ...Development, Biostatistics, and Safety to align on program strategy and data interpretation while driving standards and...MedicalRegulatory
- Allergan is seeking a seasoned Medical Director in South San Francisco to manage the direction... ...compliance, and driving scientific strategy. This role involves leading cross-... ...qualities, and a deep understanding of regulatory requirements. A comprehensive benefits package...MedicalRegulatory
- ...South San Francisco, CA is hiring a Director, CMC Regulatory Affairs to lead regulatory strategies for CMC across oncology programs. You will collaborate with regulatory,... .... The role requires strong scientific writing, experience with INDs/NDA/MAA filings, and deep...Regulatory
- Director, Head of Corporate PR Whatnot's mission... ...lead our corporate PR strategy, building and protecting... ...transitions, regulatory scrutiny, product issues... ...rapid growth Exceptional writing and messaging skills,... ...Insurance options including Medical, Dental, Vision Work...MedicalRegulatoryLocal areaWork from homeHome officeNight shift
- ...Therapeutics is seeking a Vice President of Medical Affairs, Hematology-Oncology to build and lead a best‑in‑class... ...leadership across medical strategy, field medical, and evidence generation... ...Clinical Development, Commercial, and Regulatory teams. #J-18808-Ljbffr BioSpaceMedicalRegulatory
$230k - $270k
..., including blood, vaccines, medical supplies, food, and retail products... ...and The Role As Zipline’s Head of Public Affairs, you will... ...function, including the strategy, operating model, team, tools... ...service, or business model amid regulatory, incumbent, or community opposition...MedicalRegulatoryWork at officeLocal area$198k - $257k
...transformative medicines for oncology, autoimmune disorders,... ...The Associate Director, Regulatory Affairs supports the development... ...execution of clinical regulatory strategies and regulatory development... ..., Nonclinical, Biometrics, Medical Writing, CMC, and other functions....MedicalRegulatoryFull timeWork at officeWorldwideRelocation package- ...forefront of patient care, writing medicine's next chapter... ...seeking a Vice President, Medical Affairs, Hematology-Oncology to build, expand, and... ...function, including medical strategy, field medical, scientific... ..., Market Access, Regulatory, Legal, and Compliance as...MedicalRegulatoryFull time
- ...health issues today and address the medical challenges of tomorrow. We strive... ...therapeutic areas including immunology, oncology and neuroscience - and products and... ...Job Description The Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada (Hybrid) is responsible...MedicalRegulatoryLocal area
- Maze Therapeutics is seeking a Director of Medical Writing to lead the medical writing function across clinical programs, ensuring documents... ..., consistent, and submission-ready. Reporting to the VP of Regulatory and Quality Science, you will partner with Regulatory...MedicalRegulatory
$192k - $240k
...development of clinical program strategy, building a clinical... ...protocol preparation, report writing, regulatory submissions, etc. Develop, write... ..., childbirth and related medical conditions), marital status,... ...Operations (AI Operations) Director, Oncology Patient Support Operations...MedicalRegulatoryFull timeWork at officeLocal areaRemote work$245k - $302k
...Biosciences is a precision medicine oncology company committed to the... ...Summary Senior Director, Medical Writing - Provide strategic and... ...for delivering high‑quality regulatory and clinical documents that... ...and registration strategies. Job Description Responsibilities...MedicalRegulatoryTemporary workFor contractorsLocal area- Maze Therapeutics is seeking a Director of Medical Writing to lead the medical writing function across development programs, ensuring accuracy... ..., and submission-readiness. Reporting to the VP of Regulatory and Quality Science, you will manage internal teams and external...MedicalRegulatory
$245k - $302k
...IDEAYA is a precision medicine oncology company committed to the... ...skilled Senior Director, Medical Writing to provide strategic and operational... ...delivering high‑quality regulatory and clinical documents that... ...and registration strategies. You will partner closely...MedicalRegulatoryTemporary workFor contractorsWork at office- ...today and address the medical challenges of tomorrow... ...including immunology, oncology and neuroscience - and... ...purification platform strategies and workflow improvements... ...documentation, and regulatory support documents Work... ..., including technical writing and scientific data...MedicalRegulatoryFull timeLocal area
- IDEAYA Biosciences is hiring a Senior Director of Medical Writing in South San Francisco to lead the development of clinical and regulatory documents in oncology. The role is pivotal for both early and late-stage programs and requires strong leadership skills, deep expertise...MedicalRegulatory
- ...issues today and address the medical challenges of tomorrow. We strive... ...areas including immunology, oncology and neuroscience - and... ...Director of Neuroscience Commercial Strategy - Corporate Business Strategy... ..., Sales Force Effectiveness, Regulatory, Customer Experience, and...MedicalRegulatoryWork at officeLocal areaImmediate start
$126k - $204.6k
...Lead Location: Lilly Oncology, South San Francisco,... ...propose experimental strategies Collaborate effectively... ...and organize data for regulatory compliance Required Qualifications... ...communication, writing, and presentation... ...benefits Eligibility for medical, dental, vision and...MedicalRegulatoryFull timeFlexible hours$287k - $355k
...a precision medicine oncology company committed to the... ...an experienced Senior Medical Director of Patient... ...benefit-risk assessment strategies (BRAT/BRAD). Reporting... ...interaction with external regulatory authorities. This... ...assist with narrative writing. Requirements M.D. or...MedicalRegulatoryFull timeTemporary workWork at officeLocal areaWork from home$308k - $380k
...IDEAYA is a precision medicine oncology company committed to the... ...and is accountable for both Medical Writing and the Program Management departments... ...approach, governance, regulatory compliance, high quality,... ...execute the project management strategy for IDEAYA's oncology...MedicalRegulatoryContract workTemporary workWork at officeLocal areaWork from home$186k - $235k
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...MedicalRegulatory- ...Head of Toxicology, Small Molecules About the Company... ...and a proven track record in regulatory authorship and agency engagement... ...influencing development and portfolio strategies, and a deep understanding of... .... Functions ~ Medical Care/Hospital Administration...MedicalRegulatory
$220k - $245k
Olema Oncology is a clinical-stage biopharmaceutical... ...Clinical Operations, Medical Monitors, Data Management... ...Pharmacology, Regulatory and Program Management... ...primarily encompass: Writing of technical and clinical... ...insights and develop strategies for the clinical study...MedicalRegulatoryWork at officeFlexible hours$226.19k - $292.71k
...nonclinical studies and safety strategies to support drug... ...across research and regulatory pathology areas. The primary... ..., including technical writing and... ...immunology, virology, or oncology is highly desirableExperience... ...include company-sponsored medical, dental, vision, and...MedicalRegulatoryRemote work
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