Director, Regulatory Writing

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Job description

Alumis Inc is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients.

Alumis Inc is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients.

We are seeking an experienced Director, Medical Writing in our Regulatory team.

Our Director, Medical Writing will provide strategic and operational medical writing expertise to prepare high-quality clinical regulatory documents for Health Authority submissions. This position will report directly to the VP, Regulatory Affairs and will collaborate across the organization to implement and maintain a standardized document development process for regulatory documents.

Responsibilities:

• 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)
• Oversee document preparation activities and track progress against targets; produce timely and accurate status update reports
• 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
• 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, IND sections, Briefing Documents and annual reports
• 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
• Ensure final documents adhere to standard operating procedures (SOP), good clinical practice (GCP), and International Council on Harmonization (ICH) requirements

Education:

• 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:

• 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 Values

• Elevate
• Challenge
• Nurture

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.

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