Principal Medical Writer (Plainsboro, NJ or Lexington, MA)

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 Principal Medical Writer is an expert in medical writing and performs work independently with minimal-to-no supervision. The Principal Medical Writer will work closely with cross-functional project teams, including Medical & Science, 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 Principal Medical Writer will provide high level strategic input into development plans, study designs, and regulatory submissions.

 

Relationships

The Principal Medical Writer reports to a Director of Medical Writing.

 

The Principal Medical Writer is expected to develop and maintain a strong network of internal relationships with global and local cross-functional study teams.

 

The Principal Medical Writer should be seen as a key resource for medical writing expertise and provides active leadership on local and global project teams, as needed.

 

The Principal Medical Writer will provide mentoring and direction to less-experienced medical writers, as needed.

 

Essential Functions

• Provides strategic input into documents and plans 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)
  • Deliverables for meetings with Regulatory Agencies (meeting requests, briefing books, slides, minutes)
  • Clinical study protocols and protocol amendments
  • Clinical study reports (CSR)
  • Investigator brochures (IB)
  • Responses to requests from regulatory agencies and ethics committees
  • Informed consent and assent forms
  • Lay summaries of clinical trial results
  • Clinical evaluation plans (CEP) and clinical evaluation reports (CER)
  • Pediatric investigational plans (PIP)
  • Orphan Drug applications
  • Breakthrough Therapy Designation requests

• Leads the sharing of better practices to optimize the way we work and increase awareness of medical writing within the project area: