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Regulatory Medical Writing Director
2 months ago
{"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, write, edit, format, and finalize regulatory documents including IND, CTA, 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)"}, {"li": "Oversee document preparation activities and track progress against targets; produce timely and accurate status update reports"}, {"li": "Provide oversight of document quality and consistency; documents as well as consistent style to ease of review across multiple documents assembled in a regulatory dossier or briefing package"}, {"li": "Lead document review and comment resolution meetings with cross-functional teams;"}, {"li": "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, IND sections, Briefing Documents and annual reports"}, {"li": "Develop and execute strategies for organizing and preparing documents for regulatory health authority submissions"}, {"li": "Coordinate the review and approval of documents"}, {"li": "Develop templates, style guidelines, and SOPs for clinical documentation"}, {"li": "Ensure final documents adhere to standard operating procedures (SOP), good clinical practice (GCP), and International Council on Harmonization (ICH) requirements"}], "h2": "Requirements", "ul": [{"li": "BA/BS degree in a scientific field required; advanced scientific degree (PhD, PharmD, or MS) preferred"}, {"li": "8+ years of regulatory medical writing experience in the pharmaceutical industry or CRO environment"}], "h2": "Experience", "ul": [{"li": "Experience participating in submissions to the US FDA (IND, BLA) and EMA (MAA)"}, {"li": "Able to compile, analyze, and present data clearly, concisely, and effectively."}, {"li": "Strong understanding of drug development, clinical study design, regulations (FDA and EU), ICH and scientific principles"}, {"li": "Broad knowledge of EMA/ICH guidelines and FDA guidance beyond those pertaining to specific regulatory documents"}, {"li": "Proficiency with Electronic Common Technical Document (eCTD) templates"}], "h2": "Alumis Values", "ul": [{"li": "Elevate"}, {"li": "Challenge"}, {"li": "Nurture"}], "p": "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. The salary range for this position is $220,000 USD to $240,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company's compensation practices. Alumis Inc. is an equal opportunity employer."
