Senior Manager, Medical Writing

Confirmed live in the last 24 hours

Formation Bio

Boston, MA; New York, NY

Hybrid

Posted March 30, 2026

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:

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

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