Senior Medical Writing Director - Regulatory Submissions
Socket
Corcept Therapeutics, headquartered in Redwood City, CA, seeks a medical writing professional to support regulatory submissions and ensure alignment with US and ex-US requirements. You will author, edit, and format NDAs, protocols, CSRs, and IBs, collaborating with cross-functional teams to gather input and maintain timelines. The role demands strong writing, attention to detail, and experience across therapeutic areas, with a track record in regulatory documents and familiarity with e-CTD #J-18808-Ljbffr Socket
$244k - $305k
...drug developer to serve as Senior Director of Clinical Development in... ...pivotal studies including regulatory submissions. You will play a vital... ...level, oversee the conduct of medical/safety data reviews and... ...of trial design, protocol writing/ICF (writing or amendment)...SeniorFull timeLocal area$244k - $305k
...drug developer to serve as Senior Director of Clinical Development in... ...pivotal studies including regulatory submissions. You will play a vital... ...level, oversee the conduct of medical/safety data reviews and... ...of trial design, protocol writing/ICF (writing or amendment)...SeniorFull timeLocal areaWorldwide$175k - $195k
...POSITION SUMMARYThe Senior Manager (SM), Regulatory Affairs Labeling will... ...Affairs functions, Medical Affairs, Legal, Clinical... ...to the Senior Director, Global Commercial Regulatory... ...on regulatory submissions of labeling... ...industry.Experience with writing, developing, maintaining...SeniorLocal areaFlexible hours$250k - $300k
...Park, CARegulatory Affairs - Regulatory Affairs /Regular, Full-Time... ....Position Summary: The Senior Director, Regulatory Affairs is Orca... ...incumbent will assist the Chief Medical Officer to develop and... ...preparation for future major submissions.Develop and recommend regulatory...SeniorFull timeLocal areaImmediate startRemote work- Scorpion Therapeutics in Redwood City, CA, seeks a Sr Director of Regulatory Affairs to lead strategic and operational efforts for late-stage development, regulatory submissions, and U.S. registration. You will focus on FDA interactions and shaping global regulatory plans...Senior
$295k - $339k
...clinical science drug developer to serve as Medical Director in support of Revolution Medicines’... ...of clinical data supporting regulatory submissions (NDA, BLA, MAA). This role is uniquely... ...Biostatistics, Data Management, and Medical Writing to ensure clinical datasets,...Full timeLocal area$275k - $295k
...Senior Director, Clinical Operations Department: Drug Development... ...with corporate objectives and regulatory requirements. You will lead... ...reports, and regulatory submissions, ensuring accuracy, timeliness... ...will be confirmed in writing at the time of the offer....SeniorFull time- ...ApplicationsEmail: ****@*****.*** Opportunity: Senior Clinical Program Manager, Clinical Operations Compliance &... ...Harmonization (ICH) Guidelines, Good Clinical Practices (GCP) and regulatory requirements.Support Clinical Operations with GCP guidance and...SeniorWork at office
$280k - $310k
...get it done, and have fun, seriously.POSTION SUMMARYThe Senior Director, Regulatory Affairs CMC is a position requiring a strong leader who will... .... The position will be responsible for all CMC-related submissions: strategic planning, execution, and ensuring quality and...SeniorLocal area$160k - $190k
...NeuroPace is a commercial-stage medical device company focused on... ....We are currently seeking a Senior Regulatory Affairs Manager to join our... ...study projects and related submissions for a highly technical and complex... ...communication, technical writing and editing skills and...SeniorWork at office2 days per week3 days per week- ...shape where our business and medical science goes next.We believe... ...to):Develop and implement regulatory product strategiesRepresent... ...contingenciesPlan, prepare, and review submissions to required authorities... ...preferred.Experience writing or updating processes.Experience...SeniorFull timeFor contractorsWork at officeLocal areaRemote workRelocationFlexible hours
$261.4k - $307.6k
...of growth. We are seeking a Medical Director, Oncology to play a pivotal... ...reports Participate in the writing and review of clinical... ...Participate in appropriate regulatory discussion and activities,... ...writing for global regulatory submissions Other duties as assigned Preferred...Full time$244k - $295k
...Description Description: Senior Director, Clinical Operations... ...Clinical Development, Safety, Regulatory, Biometrics, Clinical Supply... ...standards. Lead or assist in writing, reviewing, and/or... ...informed consent, IRB/EC and HA submissions/approvals, clinicaltrials....SeniorRemote workFlexible hoursShift work$166k - $195k
...making.Summary:The Sr. Project Manager, Regulatory CMC will serve as a key contributor to... ...coordination, and execution of regulatory CMC submissions — including BLAs and Prior Approval... ...meetings, sending out agendas, writing and distributing meeting summaries, managing...Senior3 days per week- ...hyperinsulinism (HI). As Rezolute expands its medical and scientific focus into tumor-... ...Reporting to the Chief Regulatory Officer, the Sr Director of Regulatory Affairs will join the... ...clinical development through regulatory submission, approval, and product launch. This...SeniorLocal area
$205.2k - $360.8k
...specific business processes, regulatory requirements, data models,... ...designing an Architect flow, writing application code, integrating... ...,800.00 Benefits: ~ Medical, Dental, and Vision... ...application follow-ups or resume submissions-may not receive a response....SeniorWork from homeWorldwideFlexible hours$229.3k - $269.8k
...more, visit As an Associate Medical Director, you will support the... ...Develop and participate in the writing and review of protocols, investigator... ...and other clinical and regulatory documents Establish and... ...for global regulatory submissions Work closely and collaboratively...Full time- ...patients for generations to come.Regulatory Submission Management (RSM) acts as a... ...together. As an Associate Director, RSM, you will have a... ...External Partnerships (IDEP), Medical Writing, and representatives from... ...compelling documentation for senior leadership, determining the...Full timeFor contractorsLocal areaRelocationFlexible hours
- ...Senior Clinical ManagerFor nearly 10 decades, Easterseals Northern... ...oversight.Supports the Director in executing the Behavioral Health... ...and alignment with funder and regulatory standards.Conducts clinical... ...effectively verbally and in writing, American Sign Language or bilingual...SeniorCasual workWork at officeLocal areaWork from homeFlexible hours
$215k - $240k
...address significant unmet medical needs? Then Ascendis Pharma... ...looking to hire an experienced Director, Regulatory Affairs Clinical Strategy... ...and scientifically valid submissions. Provides expertise in translating... ...under direction of a Senior Regulatory Affairs professional...Full timeTemporary workFlexible hours- Revolution Medicines is seeking a Senior Associate Regulatory Affairs to support management in day-to-day operations and to help coordinate submissions to global health authorities. The base pay ranges reflect onsite responsibilities at our Redwood City, CA headquarters...Senior
$200k - $235k
Senior Director of Subject Matter Expert CTEM, RBVM, ASPM Risk Operation Center (ROC) Come work at a place where innovation and teamwork come together to support the most exciting missions in the world! Location: Foster City, CA, USA Organization: Product GTM & SME Reports...Senior$275k - $300k
...Senior Medical Director, Clinical DevelopmentDren Bio is a privately held, clinical-stage biopharmaceutical company pioneering the discovery... ...include Research, Translational Sciences, Clinical Operations, Regulatory, Patient Safety, Medical Affairs, and Commercial to ensure...SeniorTemporary workLocal area$115k - $125k
...as our guiding values. The Senior Clinical Manager provides leadership... ...oversight. Supports the Director in executing the Behavioral... ...and alignment with funder and regulatory standards. Conducts clinical... ...effectively verbally and in writing, American Sign Language or bilingual...SeniorFull timeCasual workWork at officeLocal areaRemote workWork from homeFlexible hours$183k - $194k
...executes multi-product global regulatory CMC strategies for... ...and filing of regulatory CMC submissions. Manages interactions with Health... ...Affairs for Drugs, Biologics or Medical Devices).9+ years of... ...objectives.Reports to: Executive Director, Regulatory CMC Location: US...SeniorRelocationRelocation package$146k - $161k
...Clinical Trial Manager/Senior Clinical Trial Manager Waltham, Massachusetts, United... ...Overview: Will ensure trial compliance, regulatory alignment, and operational efficiency while... .... Support the preparation and submission of clinical trial applications, including...SeniorWork at officeRemote work3 days per week$244k - $305k
...signaling pathway.The Opportunity:The Sr. Director, US Compliance will serve as the lead... ...strategic compliance advisor to Commercial, Medical Affairs, Market Access, Patient Services... ...implementations, and evolving legal or regulatory requirements.The successful candidate...SeniorFull timeLocal areaShift work$164k - $205k
...Provide support preparation of anticipated regulatory inspections (including those at... ...required.Preferred Skills:Direct experience writing and negotiating Quality Agreements with... ...ancestry, age, disability, marital status, medical condition, and veteran status.Revolution...SeniorFull timeWork at officeLocal areaImmediate startWorldwideFlexible hours- ...exceptional customer experiences. As we scale, we are seeking a Senior Product Manager to shape the future of our consumer-facing products... ...workflow, we want to hear from you. Key Responsibilities: Write crisp product specifications , including user stories and...Senior
- ...Designs has partnered with Hueman to find a Medical Director. This is a fully remote position that... ...writers and mentor them in the writing of the medical content. The director will... ...drug development and medical, legal, and regulatory review Computer literacy At Custom...Full timeRemote work
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