Regulatory Writing Director
2 weeks ago
We are seeking an experienced Director, Regulatory Writing to join our Regulatory team at Alumis Inc.
Job SummaryThe successful candidate will provide strategic and operational medical writing expertise to prepare high-quality clinical regulatory documents for Health Authority submissions.
Key Responsibilities- Plan, prepare, write, edit, format, and finalize regulatory documents, including IND, CTA, NDA, clinical and non-clinical summaries, clinical protocols, clinical study reports, Investigator brochures, updates to regulatory submissions, briefing books, annual reports/development safety update reports (DSURs)
- Oversee document preparation activities and track progress against targets; produce timely and accurate status update reports
- Provide oversight of document quality and consistency; ensure documents adhere to standard operating procedures (SOP), good clinical practice (GCP), and International Council on Harmonization (ICH) requirements
- Lead document review and comment resolution meetings with cross-functional teams;
- Leverage scientific expertise to write, review, and edit science-based reports, such as the clinical protocol, Investigator's Brochure, clinical study report, informed consent, risk/benefit analysis, and integrated summary
- Develop and execute strategies for organizing and preparing documents for regulatory health authority submissions
- Coordinate the review and approval of documents
- Develop templates, style guidelines, and SOPs for clinical documentation
- BA/BS degree in a scientific field required; advanced scientific degree (PhD, PharmD, or MS) preferred
- 8+ years of regulatory medical writing experience in the pharmaceutical industry or CRO environment
- Experience participating in submissions to the US FDA (IND, BLA) and EMA (MAA)
- Able to compile, analyze, and present data clearly, concisely, and effectively
- Strong understanding of drug development, clinical study design, regulations (FDA and EU), ICH, and scientific principles
- Broad knowledge of EMA/ICH guidelines and FDA guidance beyond those pertaining to specific regulatory documents
- Proficiency with Electronic Common Technical Document (eCTD) templates
Alumis Inc. is an equal opportunity employer. We offer a competitive salary range of $220,000 USD to $240,000 USD annually, and a dynamic work environment that values innovation, collaboration, and professional growth.
This position is located in South San Francisco, CA, with the expectation of being in the office 3 days a week, Tuesday through Thursday. At this time, we are not considering remote applicants.
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South San Francisco, California, United States Alumis Full time{"h1": "Director, Regulatory Medical Writing", "p": "At Alumis Inc., we are seeking an experienced Director, Regulatory Medical Writing to join our Regulatory team. This role will provide strategic and operational medical writing expertise to prepare high-quality clinical regulatory documents for Health Authority submissions.", "ul": [{"li": "Plan, prepare,...
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