Director, 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 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

The Director of Medical Writing will be responsible for developing and implementing medical writing strategies and operational plans to support Formation Bio Clinical Development activities. The Medical Writer will have responsibilities to write or facilitate the writing of key documents, with an emphasis on clinical development related documents within the Research & Development department. This team member will be the first member of a growing team and work across multiple teams to integrate the medical writing strategies and operational plans.

Responsibilities

• Leads and manages the writing, review, and finalization of clinical development documents such as protocol synopses and protocols, Investigator’s brochures (IBs), clinical summaries and overviews, and clinical study reports (CSRs); regulatory documents (meeting and briefing packages, regulatory filings); and pharmacovigilance documents (eg, annual reports/developmental safety update reports) by serving as the document author or providing oversight to the assigned author.
• Partners with Formation Bio’s tech team members to innovate and streamline regulatory writing processes through a combination of programmed automation solutions and the use of generative AI tools
• Creates the timelines, in conjunction with the project team or relevant subteam, for completion of clinical development and pharmacovigilance related documents.
• Ensures that clinical, regulatory, and/or pharmacovigilance documents are developed in a format compliant with the governing regulatory agency (EMA, FDA, and ICH guidelines) and with electronic submission guidelines. 
• Acts as liaison between cross-functional department personnel to ensure that background materials are provided, timelines are communicated, and questions are answered for Medical Writing deliverables.
• Ensures that Medical Writing deliverables are complete, well organized, and scientifically accurate, and that messaging is consistent throughout all technical documentation to reflect the project and regulatory strategies and requirements.
• Reviews work of other functional expert writers for accuracy, quality, and appropriate messaging.
• Facilitates internal review of materials and documents and consolidates comments from internal and external reviewers (adjudication meetings). 
• Leads the development of style standards and guidelines for preparation of documents, including those submitted to health agencies, and ensures Medical Writing deliverables adhere to stylistic guidelines.
• Potentially supervises and manages external contracted medical writers to ensure quality and meeting of timelines for all clinical development  and select pharmacovigilance and/or regulatory documents as prioritized by the CMO. This could also include the coordination of working with CROs to assist in moving any of these documents to completion.
• Keeps management current on project status and provides ongoing risk assessments.
• Develops and implements continuous improvement processes for document writing processes.
• Accomplishes department objectives by managing and leading medical writing team members and contractors and deliverables.
• Potentially involved in the development of the medical writing team by effectively recruiting, selecting, orienting, and training employees.
• Ensures all tasks are carried out in accordance with applicable principles of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and regulatory guidelines.

About You

• Bachelor of Science Degree, as a minimal requirement. A advanced degree (MS or PhD) is preferred.
• 7+ years of experience in the development of clinical and regulatory documents to support drug development programs. 
• Experience as lead writer for key clinical and regulatory documents required.
• Experience mentoring or managing other writers (internal or contract) preferred.
• Understanding of FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (ie, eCTD).
• Excellent critical thinking, organizational, problem solving, negotiation, and time management skills.
• Able to effectively manage multiple assignments and adapt flexibly to changing priorities.
• Strong communication skills with the ability to simply summarize complex information verbally and in a written format.
• Able to work collaboratively on multi-disciplinary project teams and to proactively manage relationships with external medical writing vendors.
• Ability to lead and/or facilitate meetings.

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: $238,000 - $300,000.

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.

#LI-hybrid