Director of Medical Writing - Regulatory & Clinical Strategy
Initial Therapeutics, Inc.
Maze Therapeutics is seeking a Director of Medical Writing to lead the medical writing function across clinical programs, ensuring documents are accurate, consistent, and submission-ready. Reporting to the VP of Regulatory and Quality Science, you will partner with Regulatory Affairs, Clinical Development, Biostatistics, and external vendors to advance regulatory deliverables and implement scalable writing standards. #J-18808-Ljbffr Initial Therapeutics, Inc.
Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Director of Medical Writing - Regulatory & Clinical Strategy in South San Francisco, CA vacancy
$190k - $240k
...Position Title Associate Director, Clinical Scientist Reports To: VP,... ...data management, statistics, regulatory, medical affairs, and... ...Team (GPT) and the Clinical Strategy Team (CST) in the planning... ...data Proficiency in medical writing and developing high-quality...MedicalRegulatoryFlexible hours- Kardigan is seeking an Associate Director, Clinical Scientist to lead analysis and monitoring of study data across cardiovascular... ..., an advanced life-science degree, proficiency in biostatistics, medical writing, GCP and regulatory requirements. #J-18808-Ljbffr DoistMedicalRegulatory
$250k - $286k
...all aspects of critical writing activities, working... ...deliverables such as clinical study protocols, IBs,... ...Clinical/CMC, Clinical and Regulatory documents in support... ...external) to develop crucial strategy, conclusions, and... ....Build a scalable medical and scientific writing...MedicalRegulatoryWork at officeFlexible hours- ...Biotherapeutics: Director, Preclinical Sciences... ...to: Chief Medical Officer Location:... ...and optimizes pre-clinical studies and ensures... ...external collaborators. Writes pre-clinical... ...team, KOL and regulatory meetings. Establishes... ...clinical trial strategies to obtain...MedicalRegulatory
$186k - $220k
...drugs. We are advancing a clinical‐stage pipeline of... ...Summary:The Associate Director of Clinical Operations... ...execution and compliance with regulatory standards. This senior... ...timelines.Operational Strategy & Execution: Work with... ..., Safety/PV, and Medical Affairs teams to...MedicalRegulatoryContract workRemote work- ...motivated, well‑organized, and skilled Senior Director, Medical Writing to provide strategic and operational... ...Management. What You’ll Do Lead authoring strategy and oversee the successful development of clinical and regulatory documents (e.g., INDs, NDAs, BLAs, MAAs, Protocols...MedicalRegulatoryTemporary workFor contractorsLocal area
$245k - $302k
...of disease and improving clinical outcomes for patients. Location... ...Position Summary Senior Director, Medical Writing - Provide strategic and... ...for delivering high‑quality regulatory and clinical documents... ...development and registration strategies. Job Description...MedicalRegulatoryTemporary workFor contractorsLocal area$245k - $302k
...of disease and improving clinical outcomes for patients with... ...organized, and skilled Senior Director, Medical Writing to provide strategic and... ...delivering high‑quality regulatory and clinical documents that... ...development and registration strategies. You will partner closely...MedicalRegulatoryTemporary workFor contractorsWork at office$223k - $271k
...into a pivotal role where science meets strategy. At Maze, we're on a mission to uncover... .... The Impact You’ll Have Lead the medical writing function and be accountable for the development of high-quality clinical and regulatory documents across Maze’s development programs...MedicalRegulatory$190k - $280k
...protein degraders to the clinic. Lycia is... ...Therapeutics is seeking a Director or Associate Director... ...development of clinical strategies in alignment with program... ...with ICH-GCP guidelines, regulatory requirements, and... ...internal policies. Act as a medical monitor or scientific...MedicalRegulatoryWork at officeFlexible hours2 days per week3 days per weekLycia Therapeutics
South San Francisco, CA1 day ago$155k - $190k
...Job Title: Associate Director, Clinical Data Systems and Informatics Location... ...in accordance with regulatory inspection readiness standards... ...experience preferred Strong writing skills and experience documenting... ...Familiar with cancer‑related medical classifications and...MedicalRegulatoryClearnotehealth
San Mateo, CA2 days ago- We are seeking an Associate Director, Medical Writing to lead the development and execution of high-quality clinical and regulatory documentation. This individual will play a key role in shaping document strategy, managing the end-to-end writing process, and ensuring compliance...MedicalRegulatoryContract workWork at office
$186k - $235k
...drugs. We are advancing a clinical‑stage pipeline of differentiated... ...Summary The Associate Director of Medical Writing will be responsible for... ...leading the development of key regulatory and clinical documents... ...and implement mitigation strategies to support successful outcomes...MedicalRegulatoryRemote work$198k - $257k
...strategic partner for global clinical development. Our unique... ...Function: The Associate Director, Regulatory Affairs supports the... ...execution of clinical regulatory strategies and regulatory development... ...Nonclinical, Biometrics, Medical Writing, CMC, and other functions....MedicalRegulatoryFull timeWork at officeWorldwideRelocation packageZai Lab (US) LLC
South San Francisco, CA13 days ago$171k - $223k
Neurodegenerative diseases are one of the largest medical challenges of our time. Denali... ...therapeutics to patients. Associate Director, Clinical Regulatory The Associate Director, Clinical... ...Accountable for developing regulatory strategy for complex development programs;...MedicalRegulatoryWork experience placementLocal area- Maze Therapeutics is seeking a senior regulatory medical writer to lead the function across development... .... You will develop high-quality clinical and regulatory documents and manage... ...Biostatistics, and Safety to align on program strategy and data interpretation while driving...MedicalRegulatory
$144k - $240k
...targeted therapies with outsized clinical impact, faster. To accomplish... ...edge knowledge of best regulatory practices, quantitative/clinical... ...Clinical Pharmacology strategy in the context of the broader... ...range of benefits that include medical, dental, life, long and short...MedicalRegulatoryTemporary workLocal area$230k - $240k
...exciting place to catalyze and enable medical breakthroughs.Position Description:Calico is seeking an Associate Director, Medical Writing to provide leadership and functional... .../approval process of high quality clinical and regulatory documents, in compliance with applicable...MedicalRegulatoryWork at office- Allergan is seeking a seasoned Medical Director in South San Francisco to manage the direction of clinical trials, ensuring compliance, and driving scientific strategy. This role involves leading... ..., and a deep understanding of regulatory requirements. A comprehensive...MedicalRegulatory
$243.1k - $314.6k
...for generations to come. As the Director, US Medical Affairs, Liver Strategy, at Gilead you are a critical strategic... ...narrative by translating emerging clinical, real-world, and guideline data... ...cross-functionally with Legal, Regulatory, Commercial, HEOR, GMA, Clinical,...MedicalRegulatoryFull timeFor contractorsLocal area- 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
- ...seeking a highly experienced clinical development leader to drive mid... ...-stage programs and ensure regulatory success. The role partners with... ..., and research to shape strategy and execution. The successful candidate will supervise medical monitoring, safety, and regulatory...MedicalRegulatory
- ...DescriptionThe Associate Director US Medical Affairs, Patient... ...Medical Affairs (MA) strategies and Plans of Action (... ...with research teams (Clinical Development, Medical... ...outcomes research including writing research protocols,... ...working knowledge of regulatory and compliance...MedicalRegulatoryFull timeFor contractorsLocal area
- ...are looking for an Associate Director, Clinical Pharmacology based in our... ...input into product development strategies and/or research or clinical... ...documents for clinical and regulatory submissions.Presents... ...include company-sponsored medical, dental, vision, and life insurance...MedicalRegulatoryFull timeFor contractorsWork at officeLocal areaFlexible hours
$176.5k - $246.5k
...Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical... ...is looking for an Associate Director, Clinical Operations, responsible... ...study teamsAble to support regulatory strategy and assess trial/program impact... ...management, biostatistics, medical monitoring, drug safety,...MedicalRegulatoryFull timeWork at officeWork visa3 days per week- Annexon Biosciences seeks a Senior Director of Medical and Scientific Writing to lead the creation of crucial clinical and regulatory documents. You will partner with Clinical, Regulatory, Quality, Medical Affairs, and Commercial teams to interpret data, shape messaging...MedicalRegulatoryRemote job
$250k
...Job Description Senior Director, Partnerships, Platform Go-to-Market Strategy & Activation (Butterfly... ...digital revolution in medical imaging, transforming an... ...to help clinicians, clinics, and hospitals enhance... ...sectors. Familiarity with regulatory pathways (e.g., FDA)...MedicalRegulatoryH1bWork at officeImmediate startShift work2 days per weekButterfly Network
San Francisco, CA15 days ago- ...Senior Director, Clinical Pharmacology Kardigan is a heart health company... ...clinical pharmacology strategies from early through late-... ...stage development, supporting regulatory submissions, and serving... ..., Regulatory Affairs, Medical Writing, CMC, Research, and other...MedicalRegulatory
Kardigan
South San Francisco, CA4 days ago $280k - $320k
...an opportunity for a Sr. Director, Medical Writing to join the Development Team... ...scientific, medical, and regulatory writing activities for all... ...full life-cycle support from clinical study protocols through... ...operational issues, providing strategy and direction for major...MedicalRegulatoryLocal area- Who We AreNoah Medical is building the future of medical robotics... ...will lead the "upstream" strategy—identifying unmet clinical needs and translating... ...software, AI, and strict regulatory environments to deliver... ...development, and report writing. Act as a subject matter...MedicalRegulatoryFull timeWork at officeLocal areaRemote workWorldwideFlexible hours
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Director of Medical Writing - Regulatory & Clinical Strategy. Be the first to apply!
Related searches
- associate director compliance South San Francisco, CA
- director global regulatory affairs South San Francisco, CA
- senior director regulatory affairs South San Francisco, CA
- regulatory cmc manager South San Francisco, CA
- regulatory affairs manager pharmaceutical South San Francisco, CA
- healthcare compliance manager South San Francisco, CA
- regulatory manager South San Francisco, CA
- manager regulatory affairs South San Francisco, CA
- regulatory & compliance manager South San Francisco, CA
- head compliance South San Francisco, CA