Director, Medical Writing

Job Summary:

The Director, Medical Writing is a hands-on leadership role responsible for clear scientific messaging and for the development, coordination, and delivery 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 functional leadership of medical writing, ensuring that deliverables meet high standards of scientific accuracy, regulatory compliance, and clarity.

The Director owns the design and implementation of medical writing processes, templates, and standards, builds and manages internal writing capability, and directs the selection, oversight, and performance of external writing vendors within an agreed budget. 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 while carrying accountability for people management, vendor and budget management, and delivery across multiple concurrent programs as submission activity expands.

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, authoring, coordinating, and reviewing 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 defining the strategy for submission narratives and key messages, leading scientific messaging consistency across CTD modules. Represent Medical Writing in cross functional and governance forums and drive alignment on submission strategy and document readiness.
• Direct planning and sequencing of document deliverables with Clinical Development, Nonclinical, Biostatistics, Safety, and Regulatory Affairs; own integrated timelines and trackers across concurrent programs, coordinate cross functional review cycles, anticipate and mitigate bottlenecks, and provide regular, transparent status updates to cross functional teams and leadership.
• Manage and develop medical writing staff and contract writers
• Manage medical writing vendors, including selection, scope definition, deliverable tracking, quality oversight, and performance review. Own the Medical Writing budget and forecast internal FTE and vendor capacity against the program plan.
• Establish, document, and maintain the process for authoring, review, QC, and approval of regulatory documents submitted to health authorities, including SOPs, style guides, and templates aligned with ICH and regional requirements. Develop and deliver training to the cross functional team to ensure adoption of the agreed process.
• Support Health Authority briefing documents, meeting request packages, and written responses to Agency queries.
• Manage the Medical Writing function budget and resource planning, including FTE capacity and vendor utilization forecasting.
• 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 10+ 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 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.
• Proficiency with AI-assisted authoring and review tools applied to regulatory and clinical documents is strongly preferred, including practical understanding best prompt practices, limitations, quality control requirements, and appropriate use in a regulated environment.
• Experience building or scaling a Medical Writing function in an early-stage or rapidly growing biotech organization is highly desirable.
• Demonstrated ability to lead, mentor, and develop cross-functional teams in a fast-paced, resource-constrained biotech or pharmaceutical environment; fosters a culture of accountability, inclusion, and continuous learning.
• Proven track record of influencing without authority across organizational boundaries, driving alignment among senior stakeholders, and building consensus on complex scientific or operational priorities.
• 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.