Medical Writing Director

Summary

Join Formation Bio, a tech-driven pharma company revolutionizing drug development, as their Director of Medical Writing. You will lead and manage the writing and review of clinical development documents, partnering with the tech team to innovate writing processes using AI. Responsibilities include creating timelines, ensuring regulatory compliance, acting as a liaison between departments, and reviewing the work of other writers. You will also develop style guidelines, potentially supervise external writers, and keep management updated on project status. This role requires a Bachelor of Science degree, 7+ years of experience in clinical and regulatory document development, and experience as a lead writer for key documents. Formation Bio offers a competitive salary, equity, generous perks, hybrid flexibility, and comprehensive benefits.

Requirements

• Bachelor of Science Degree
• 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
• 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

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

Preferred Qualifications

• A advanced degree (MS or PhD)
• Experience mentoring or managing other writers (internal or contract)

Benefits

• Equity
• Generous perks
• Hybrid flexibility
• Comprehensive benefits