Job Description
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 TrialSpark 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.
You can read more at the following links:
- Our Vision for AI in Pharma
- Our Current Drug Portfolio
- Our Technology & Platform
At Formation Bio, our values are the driving force behind our mission to revolutionize the pharma industry. Every team and individual at the company shares these same values, and every team and individual plays a key part in our mission to bring new treatments to patients faster and more efficiently.
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.
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
About You 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 PharmD) in a scientific discipline with 3-5+ years of experience in pharmaceutical or biotech medical writing, or BS/MS degree with 8-12+ years of industry experience. Ideal candidates view their role not just as a producer of documents but as a critical and central component of organizational success. You're not afraid to extend your impact outside the medical writing role while also embracing radical ownership and a "no-task-too-small" mentality. This role will reside in the Clinical Development organization but will include extensive cross-functional collaboration.
Essential Experience - 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
What Sets You Apart - 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
Nice-to-Haves - 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
Why Join Us? - 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
Formation Bio is prioritizing hiring in key hubs, primarily the New York City and Boston metro areas, with additional growth in the Research Triangle (NC) and San Francisco Bay Area.
Please only apply if you reside in these locations or are willing to relocate. Compensation: The target salary range for this role is: $167,000 - $220,000. Salary ranges are informed by a number of factors including geographic location. The range provided includes base salary only. In addition to base salary, we offer equity, comprehensive benefits, generous perks, hybrid flexibility, and more. If this range doesn't match your expectations, please still apply because we may have something else for you.
You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
Job Tags
For contractors, Work at office, Relocation,