Associate Director

Job Summary:

The Associate Director, Regulatory Affairs Medical Writing is a hands-on role responsible for clear scientific messaging, the development and coordination of high-quality regulatory, nonclinical, clinical, and other scientific documents in support of the company’s I&I pipeline. This position combines active document authorship with day-to-day operational leadership of medical writing activities, ensuring that deliverables meet high standards of scientific accuracy, regulatory compliance, and clarity.

The Associate Director plays a key role in establishing and maintaining effective medical writing processes and templates, supporting the build-out of internal capabilities while pragmatically leveraging external writing resources. The role partners closely with Clinical Development, Regulatory Affairs, Biostatistics, Medical Affairs, and external vendors to plan, author, review, and deliver documents supporting critical regulatory milestones, including INDs, amendments, briefing packages, and selected NDA/BLA components. This role is expected to remain closely involved in the hands-on execution of core documents as well as coordination and leadership responsibility as programs and submission activity expand.

Work Arrangement & Location: 

Remote - This position is designated as remote; the incumbent will be expected to travel to Beeline Medicines’ offices on a periodic basis to support in-person collaboration, team engagement, and business operations. The frequency and scheduling of such visits will be determined at the company's discretion based on business need.

Essential Duties and Responsibilities:

• Own day‑to‑day execution of medical writing activities, contributing directly to authoring and quality review while coordinating internal and external resources to ensure high‑quality, on‑time delivery of regulatory and scientific documents.
• Author, coordinate, and review key clinical and regulatory documents, including protocols and amendments, CSRs, IBs, SAPs, ICFs, INDs/CTAs, and selected BLA/NDA components, ensuring scientific accuracy, regulatory compliance, and consistency of content.
• Contribute to shaping the strategy for submission narratives and key messages, leading scientific messaging consistency across CTD modules. Represent Medical Writing in relevant cross‑functional and governance forums to support alignment on submission strategy and document readiness.
• Collaborate closely with Clinical Development, Nonclinical, Biostatistics, Safety, and Regulatory Affairs to plan, sequence, and execute document deliverables, coordinating cross‑functional review cycles and ensuring timely, integrated input.
• Provide practical guidance and oversight to internal contributors and external medical writers, including vendor management, scope definition, deliverable tracking, and consistent application of Medical Writing standards, templates, and SOPs aligned with ICH and regional requirements.
• Own document timelines and individually or in collaboration with project management, maintain and actively manage integrated trackers across programs, partnering with line management to align on resourcing needs, anticipate and mitigate bottlenecks, and finding creative ways to provide regular, transparent status updates to cross‑functional teams and leadership.
• Establish a clear process for the authoring, review, QC and approval of regulatory documents to be submitted to heath authorities. Develop training materials for the cross functional team to ensure adoption of the agreed process.
• Collaborate with IT, Quality, and Regulatory stakeholders to evaluate AI and digital tools that enhance medical writing efficiency and consistency, while ensuring compliance with data privacy, system validation, and regulatory expectations; remain current on evolving regulatory guidance and industry best practices.
• Perform other duties and responsibilities as assigned.

Qualifications:

• Education: Advanced degree (PhD, PharmD, or master's level) in life sciences, pharmacology, biomedical sciences, or a related discipline required.
• 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, including CSRs, ISS/ISE, IBs, and IND/CTA packages.
• Deep scientific expertise in immunology, inflammation, or autoimmune disease is strongly preferred, with the ability to rapidly acquire technical knowledge in new therapeutic areas.
• Demonstrated ability to manage multiple concurrent document deliverables and writing teams in a high-priority regulatory environment.
• Thorough knowledge of FDA and EMA regulatory writing requirements, ICH E3, E6, E8, and M4 guidelines, and applicable pharmacovigilance documentation standards.
• Experience developing and enforcing Medical Writing SOPs, style guides, and document templates in a regulated pharmaceutical environment.
• Proficiency with document management systems, electronic submission tools, and publishing platforms such as Veeva Vault or equivalent.
• Strong publication planning experience, including familiarity with ICMJE authorship guidelines, journal submission processes, and scientific congress submission requirements.
• Experience building or scaling a Medical Writing function in an early-stage or rapidly growing biotech organization is highly desirable.
• Exceptional written and verbal communication skills with demonstrated ability to translate complex scientific, regulatory, or operational content for diverse audiences, including executive leadership, clinical teams, and external partners.
• Skilled at preparing and delivering compelling presentations, briefing documents, and strategic updates to cross-functional leadership teams and board-level stakeholders.
• Strong active listening skills and the ability to synthesize input from diverse perspectives into clear, actionable communications that build alignment and drive decision-making.