Associate Director, Medical Writing

Formation Bio • Boston, MA

7d • Hybrid

About The Position

Formation Bio is harnessing the power of deep learning and AI to transform how drugs and biologics are developed. As we build our portfolio of clinical-stage assets we are looking for an exceptional medical writing colleague who takes ownership of the development of high-quality documents while also shaping strategy and managing complex, multi-program timelines. This is not an isolated, deliverable-based medical writing role; we need a strategic partner to join the current head of medical writing, collaborate across many functions, and influence how we communicate with regulators and the broader scientific community.
You'll lead diverse medical writing activities across our drug portfolio and craft compelling, submission-ready documents that advance our programs. We expect this person to help shape our approach to regulatory communication, manage competing priorities across multiple assets, and directly impact the speed and quality of our clinical development. It is expected that you will have visibility and impact across our entire drug portfolio, from Phase 1 through to NDA/BLA.
There is a preference for a NYC- or Boston-based candidate committed to coming into one of our offices (we are hybrid in-office), with consideration for candidates in the San Francisco Bay Area and Research Triangle (NC) as we continue to grow our presence in those locations.

Requirements

• Deep expertise across the full range of clinical, nonclinical, and regulatory documents, including Phase 1 to Phase 3 protocols, IBs, CSRs, CTD modules (including clinical and nonclinical Module 2 summaries, as well as Module 4 and Module 5 study reports), and briefing documents (among others)
• Proven track record supporting IND/CTA submissions and NDA/BLA preparation, including adapting documentation from in-licensed assets to support internal needs
• Experience managing medical writing deliverables for multiple concurrent programs at different development stages
• Experience with a variety of industry standard templates, deep understanding of regulatory guidance, and subject matter expert-level understanding of platforms like Veeva RIM, Smartsheet, SharePoint, etc.
• Strong project management capabilities with demonstrated ability to coordinate detailed drafting and review timelines and coordinate across functions
• Excellent understanding of ICH guidelines, FDA/EMA regulatory requirements, and industry best practices
• Ability to translate complex scientific and clinical data into clear, compelling narratives
• Experience managing external writers or writing vendors
• Ability to operate independently while building strong internal relationships

Nice To Haves

• Flexibility and dedication to delivery of high-quality documents by whatever means necessary
• Willing to voice scientifically sound, informed opinions in meetings rather than wait for instruction
• Experience with biologics and small molecules
• Background in both small biotech companies and mid-to-large pharma
• Track record of contributing to successful regulatory submissions ranging from FIH IND applications to NDA/BLA approvals
• Applied knowledge of and demonstrated ability to use AI and modern technology tools that enhance writing efficiency
• Experience with accelerated regulatory pathways
• Familiarity with global submission requirements beyond FDA and EMA
• Prior experience scaling medical writing bandwidth using contractors and/or modern technology

Responsibilities

• Drive medical writing across multiple programs spanning diverse document types including regulatory submissions (eg, common technical document [CTD] modules), clinical protocols, investigator’s brochures (IBs), clinical study reports (CSRs), safety narratives, briefing documents, and more
• Own project timelines and processes for medical writing deliverables, proactively identifying risks, adapting processes, and driving resolution across teams
• Expand what's possible by partnering with leading-edge AI tools; help build the playbook for AI-augmented medical writing
• Work alongside the current head of medical writing to build a medical writing department from the ground up
• Partner with Regulatory on developing regulatory strategy, alongside broader program strategy influenced by Clinical and Nonclinical scientific teams
• Partner with Biostatistics and Data Management to ensure accurate, clear presentation of clinical data
• Collaborate with CMC teams to provide limited support for their documentation when appropriate
• Develop and maintain Formation-specific document templates, style guides, and quality standards
• Manage relationships with external medical writing vendors when needed, ensuring quality and alignment with internal standards
• Advise cross-functional teams on regulatory communication best practices and emerging guidance where appropriate

Benefits

• Impact: Shape how we communicate our science to regulators across a portfolio of clinical assets with real potential to help patients
• Ownership: Build and refine medical writing processes with high autonomy and strategic influence
• Innovation: Work at the intersection of AI and pharma, helping define new approaches to regulatory documentation
• Culture: Collaborate with a leader that values speed, innovation, and results
• equity
• comprehensive benefits
• generous perks
• hybrid flexibility

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree
• Number of Employees: 101-250 employees