Director - Medical Writing

About the Department                                                                                                                                             

Our East Coast Global Development Hub brings together the best minds in life science innovation with facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple innovative modalities and therapeutic areas. Our East Coast Global Development Hub merges biotech speed and agility with large pharmaceutical company quality, resources, and stability, uniting the best of both worlds to develop new medicines for patients. We recognize that improving human health starts here and that patients rely on us. We’re changing lives for a living. Are you ready to make a difference?

 

The Position

The Director, Medical Writing is an expert in medical writing and performs work independently with minimal-to-no supervision. The Director will work closely with cross-functional project teams, including Clinical Development, Clinical Operations, Biometrics, and Regulatory Affairs personnel to manage preparation of the written deliverables that support the clinical development and regulatory requirements of a clinical program. The Director will provide high level strategic input into development plans, study designs, and regulatory submissions. The Director will provide direction and mentoring to other members of the Medical Writing team.

 

Relationships

The Director Medical Writing (Director) reports to a Senior Director of Medical Writing. A key focus of this leadership role will be to develop and maintain a strong network of internal relationships with global and local cross-functional study teams. The Director will be seen as a key resource and SME for medical writing and will provide leadership on local and global project teams.

 

This role will be a senior member of the Regulatory, Quality and Clinical Reporting (RQC) team, and will provide mentorship and coaching to other members of the team. The Director may directly supervise other members of the Medical Writing team.

 

Essential Functions

• Provides strategic input to support clinical operations and regulatory submissions across a range of development programs and therapeutic areas:
  • Uses professional experience to provide advanced input into study designs, analysis plans, and regulatory submissions/ applications
  • Analyzes proposed study plans and related documents for their ability to deliver the information required by the target audience
  • Collaborates with others to develop key messages for complex clinical/regulatory documents
• Authors, reviews and/or edits documents to support clinical trials and regulatory submissions, which may include:
  • Clinical summary and overview documents in eCTD format for global regulatory submissions, including investigational medicinal product dossiers (IMPD), investigational new drug applications (IND), clinical trial applications (CTA), marketing authorization applications (MAA), and new drug applications (NDA)
  • Clinical study protocols and protocol amendments
  • Clinical study reports (CSR)
  • Investigator brochures (IB)
  • Deliverables for meetings with Regulatory Agencies (meeting requests, briefing books, slides, minutes)
  • Responses to requests from regulatory agencies and ethics committees
  • Pediatric investigational plans (PIP)
  • Orphan Drug applications
  • Breakthrough Therapy Designation requests

• Mentoring, Process Improvement, and Resource Planning:
  • Coaches, mentors, and trains staff in the finer points of medical writing
  • Assesses the overall quality and readability of documents; provides clear feedback to document authors to improve presentation and/or clarity
  • Drives innovation initiatives and continuous improvements across skill areas
  • Assists in resource planning and prioritization of medical writing tasks to ensure optimal and flexible use of resources, including timely identification and resolution of resource gaps
• General Tasks:
  • Provides leadership in local and global project teams and facilitates collaboration and collective decision making
  • Has a strategic portfolio mindset. Is able to influence strategy and translate strategy into daily operations
  • Can identify and resolve complex problems related to Medical Writing projects, processes, or tasks
  • Uses substantial depth and breadth of knowledge across the value chain to contribute to the future strategy of Clinical Reporting

 

Physical Requiremen