Senior Director, Medical Writing (Hybrid)

Responsibilities

• Lead and direct all aspects of critical writing activities, working cross-functionally to develop and produce high-quality deliverables such as clinical study protocols, IBs, CSRs, INDs/CTDs/amendments, analysis and development plans, safety updates and annual reports, narratives/summaries, briefing books, and additional Research/Pre-Clinical/CMC, Clinical, and Regulatory documents in support of programs.
• Partner with cross-functional teams to critically analyze and interpret non-clinical and clinical data (internal and external) to develop crucial strategy, conclusions, and messaging.
• Perform literature and scientific database searches as needed to support analyses and development of background summaries.
• Participate on teams as a key thought leader to develop strategy and approach, ensuring consistency and efficiency in messaging and document organization, while contributing scientific knowledge and analytical skills.
• Build a scalable medical and scientific writing infrastructure, emphasizing resourcing, formats, templates, processes, standards, style guides, workflow, and operating procedures, including management of the department budget.
• Collaborate closely with teams to develop realistic timelines for writing deliverables and program goals.
• Collaborate with internal and external authors/vendors to support the development of written deliverables, overseeing operational considerations and ensuring awareness of expectations, milestones, and deliverables.
• Ensure document content and style adhere to company guidelines and ICH/FDA/EMEA or other appropriate compliance requirements.

Requirements

• Bachelor’s/Master’s degree or Ph.D./equivalent in a scientific discipline with a minimum of 10 years of scientific, medical, or technical writing experience.
• Prior work history at a biotech or pharmaceutical company preferred; smaller company environment ideal.
• Strong background and track record of producing high-quality scientific and medical documents for internal/external distribution.
• Strategic and flexible thinker capable of translating complex data into clear, understandable, and compelling written summaries, interpretations, and positions for multiple audiences.
• Ability to work, communicate, and collaborate with colleagues and external stakeholders as a team player with transparency in a data-driven, fast-paced environment.
• Capability and comfort with prioritizing multiple projects, deliverables, and timelines to exercise thoughtful judgment, problem-solving, and decision-making.
• Ability to think ahead and identify opportunities for change and improvement with an emphasis on operations and efficiency.
• Superior attention to detail and thoroughness related to processes, consistency, grammar, syntax, and scientific accuracy.
• Prior experience building a scientific and medical writing infrastructure and template repository is a plus.
• Exceptional computer skills and familiarity with key software and cloud programs for document creation (e.g., Microsoft Office, Adobe), sharing/editing (e.g., SharePoint, GraphPad, Tableau), and data visualization (e.g., Spotfire).

Pay

$250,000–$286,000 based on experience.