Director, Medical Writing Position Available In New York, New York

Job Description:

About Formation Bio Formation Bio is a tech and AI driven pharmacompany differentiated by radically more efficient drugdevelopment. Advancements in AI and drug discovery are creatingmore candidate drugs than the industry can progress because of thehigh cost and time of clinical trials. Recognizing that thisdevelopment bottleneck may ultimately limit the number of newmedicines that can reach patients, Formation Bio, founded in 2016as TrialSpark Inc., has built technology platforms, processes, andcapabilities to accelerate all aspects of drug development andclinical trials. Formation Bio partners, acquires, or in-licensesdrugs from pharma companies, research organizations, and biotechsto develop programs past clinical proof of concept and beyond,ultimately helping to bring new medicines to patients. The companyis backed by investors across pharma and tech, including a16z,Sequoia, Sanofi, Thrive Capital, Sam Altman, John Doerr, SparkCapital, SV Angel Growth, and others. You can read more at thefollowing links: Our Vision for AI in Pharma Our Current DrugPortfolio Our Technology & Platform At Formation Bio, our valuesare the driving force behind our mission to revolutionize thepharma industry. Every team and individual at the company sharesthese same values, and every team and individual plays a key partin our mission to bring new treatments to patients faster and moreefficiently. About the Position The Director of Medical Writingwill be responsible for developing and implementing medical writingstrategies and operational plans to support Formation Bio ClinicalDevelopment activities. The Medical Writer will haveresponsibilities to write or facilitate the writing of keydocuments, with an emphasis on clinical development relateddocuments within the Research & Development department. This teammember will be the first member of a growing team and work acrossmultiple teams to integrate the medical writing strategies andoperational plans. Responsibilities Leads and manages the writing,review, and finalization of clinical development documents such asprotocol 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, annualreports/developmental safety update reports) by serving as thedocument author or providing oversight to the assigned author.

Partners with Formation Bio’s tech team members to innovate andstreamline regulatory writing processes through a combination ofprogrammed automation solutions and the use of generative AI toolsCreates the timelines, in conjunction with the project team orrelevant subteam, for completion of clinical development andpharmacovigilance related documents. Ensures that clinical,regulatory, and/or pharmacovigilance documents are developed in aformat compliant with the governing regulatory agency (EMA, FDA,and ICH guidelines) and with electronic submission guidelines. Actsas liaison between cross-functional department personnel to ensurethat background materials are provided, timelines are communicated,and questions are answered for Medical Writing deliverables.

Ensures that Medical Writing deliverables are complete, wellorganized, and scientifically accurate, and that messaging isconsistent throughout all technical documentation to reflect theproject and regulatory strategies and requirements. Reviews work ofother functional expert writers for accuracy, quality, andappropriate messaging. Facilitates internal review of materials anddocuments and consolidates comments from internal and externalreviewers (adjudication meetings). Leads the development of stylestandards and guidelines for preparation of documents, includingthose submitted to health agencies, and ensures Medical Writingdeliverables adhere to stylistic guidelines. Potentially supervisesand manages external contracted medical writers to ensure qualityand meeting of timelines for all clinical development and selectpharmacovigilance and/or regulatory documents as prioritized by theCMO. This could also include the coordination of working with CROsto assist in moving any of these documents to completion. Keepsmanagement current on project status and provides ongoing riskassessments. Develops and implements continuous improvementprocesses for document writing processes. Accomplishes departmentobjectives by managing and leading medical writing team members andcontractors and deliverables. Potentially involved in thedevelopment of the medical writing team by effectively recruiting,selecting, orienting, and training employees. Ensures all tasks arecarried out in accordance with applicable principles of GoodClinical Practice (GCP), Standard Operating Procedures (SOPs), andregulatory guidelines. About You Bachelor of Science Degree, as aminimal requirement. A advanced degree (MS or PhD) is preferred. 7years of experience in the development of clinical and regulatorydocuments to support drug development programs. Experience as leadwriter for key clinical and regulatory documents required.

Experience mentoring or managing other writers (internal orcontract) preferred. Understanding of FDA/internationalregulations, ICH guidelines, and applicable US/internationalregulatory processes related to document preparation and production(ie, eCTD). Excellent critical thinking, organizational, problemsolving, negotiation, and time management skills. Able toeffectively manage multiple assignments and adapt flexibly tochanging priorities. Strong communication skills with the abilityto simply summarize complex information verbally and in a writtenformat. Able to work collaboratively on multi-disciplinary projectteams and to proactively manage relationships with external medicalwriting vendors. Ability to lead and/or facilitate meetings.

Formation Bio is prioritizing hiring in key hubs, primarily the NewYork City and Boston metro areas, with additional growth in theResearch Triangle (NC) and San Francisco Bay Area. Please onlyapply 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 factorsincluding geographic location. The range provided includes basesalary only. In addition to base salary, we offer equity,comprehensive benefits, generous perks, hybrid flexibility, andmore. If this range doesn’t match your expectations, please stillapply because we may have something else for you. You will receiveconsideration for employment without regard to race, color,religion, gender, gender identity or expression, sexualorientation, national origin, genetics, disability, age, or veteranstatus. LI-hybrid