Director – Medical Writing

Director – Medical Writing

Requirements

• 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.
• 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.
• 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.

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

• Experience mentoring or managing other writers (internal or contract) preferred.