Associate Director, Regulatory Affairs Medical Writing
New
B
Beeline MedicinesBiotechnology
United StatesFull-TimeManager
Salary$193,000 — $215,000 USD
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Job Details
- Experience
- 7+ years
Requirements
- Advanced degree (PhD, PharmD, or master's level) in life sciences, pharmacology, biomedical sciences, or related discipline.
- Minimum of 7+ years of medical writing experience in the pharmaceutical or biotech industry.
- Extensive experience authoring and overseeing regulatory submissions in ICH CTD format (CSRs, ISS/ISE, IBs, IND/CTA, BLA/NDA).
- Thorough knowledge of FDA and EMA regulatory writing requirements, ICH E3, E6, E8, and M4 guidelines.
- Demonstrated ability to manage multiple concurrent document deliverables and writing teams.
- Proficiency with document management systems, electronic submission tools, and publishing platforms such as Veeva Vault.
- Experience developing and enforcing Medical Writing SOPs, style guides, and document templates.
- Strong publication planning experience, including familiarity with ICMJE authorship guidelines.
- Exceptional written and verbal communication skills with the ability to translate complex content for diverse audiences.
- Strong active listening skills and ability to synthesize input into actionable communications.
Responsibilities
- Own day‑to‑day execution of medical writing activities, contributing directly to authoring and quality review while coordinating internal and external resources.
- Author, coordinate, and review key clinical and regulatory documents, including protocols, CSRs, IBs, SAPs, ICFs, INDs/CTAs, and selected BLA/NDA components.
- Contribute to submission strategy and lead scientific messaging consistency across CTD modules.
- Collaborate with Clinical Development, Nonclinical, Biostatistics, Safety, and Regulatory Affairs to plan and execute document deliverables.
- Provide oversight to internal contributors and external medical writers, ensuring alignment with SOPs and templates.
- Manage document timelines, track deliverables, and provide status updates to cross-functional teams and leadership.
- Establish processes for authoring, review, QC, and approval of regulatory documents.
- Evaluate AI and digital tools to enhance writing efficiency while ensuring compliance.
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