Job Details

Responsibilities include: 

• 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 our programs.
• In partnership with cross-functional teams, critically analyze and interpret non-clinical and clinical data (internal and external) to develop crucial strategy, conclusions, and messaging.  As needed, perform literature and scientific database searches in support of analyses and development of background summaries.  
• Participate on teams as a key thought leader to develop strategy and approach, ensuring consistency and efficiency with how messaging and documents are built and organized, contributing scientific knowledge and analytical skills.
• Build a scalable medical and scientific writing infrastructure, with an emphasis on resourcing, that includes developing formats, templates, processes and standards, style guides, workflow, and operating procedures.  Also includes management of the department budget. You will collaborate closely with teams to develop realistic timelines to meet writing deliverables and program goals.
• As needed, collaborate with internal and external authors/vendors in support of the development of written deliverables, overseeing operational considerations and ensuring awareness of expectations, milestones, and deliverables.
• Ensure that document content and style adhere to company guidelines as well as ICH/FDA/EMEA or other appropriate requirements for compliance

Education, Experience, and Skills: 
Required: 

• 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.
• A strong background and track record of producing high quality scientific and medical documents for internal/external distribution.  
• A strategic and flexible thinker who can translate 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, and exciting 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, etc.) sharing/editing (e.g., Sharepoint, Graphpad, Tableau, etc.), and data visualization (e.g., Spotfire, etc.). 

Comp $250-286K based on experience