Senior Manager, Medical Writing

About Formation Bio

Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug discovery are creating more candidate drugs than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of new medicines that can reach patients, Formation Bio, founded in 2016 as Trial Spark Inc.,

has built technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines to patients. The company is backed by investors across pharma and tech, including a16z, Sequoia, Sanofi, Thrive Capital, Sam Altman, John Doerr, Spark Capital, SV Angel Growth, and others.

• Our Vision for AI in Pharma
• Our Current Drug Portfolio
• Our Technology & Platform

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.

• 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

You’re an experienced medical writing professional who combines deep technical expertise with strategic thinking and exceptional project management skills. You preferably hold an advanced degree (eg, PhD or Pharm

D) in a scientific discipline with 3-5+ years of experience in…