Senior 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 Senior Medical Writer works closely with cross-functional project teams to manage preparation of the written deliverables that support the clinical development and regulatory requirements of a clinical program.

 

Relationships

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

 

The Senior Medical Writer is expected to develop and maintain a network of internal relationships with global and local cross-functional study teams, including personnel from Medical & Science, Clinical Pharmacology, Biostatistics, Clinical Operations, Regulatory Affairs, Global Safety, Data Management, and Non-clinical Development.

 

Essential Functions

• Authors, edits, and provides QC review of documents to support clinical trials and regulatory submissions, which may include:
  • Clinical study protocols and protocol amendments
  • Clinical study reports (CSR)
  • Investigator brochures (IB)
  • 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
  • Clinical summary and overview documents in eCTD format for global regulatory submissions
• Shares knowledge and experience to optimize and simplify the way we work
  • Reviews proposed study plans and related documents for their ability to deliver the information required by the target audience
  • Initiates knowledge sharing and contributes to process improvements within the medical writing area
  • Actively participates in relevant meetings, training sessions, and seminars in the department and relevant project(s)
  • Can identify and resolve problems related to Medical Writing projects, processes, or tasks, with management support as needed
  • Provides support to others in the department

• General Tasks:
  • Interprets and accurately presents clinical and statistical data in a clear, concise format
  • Leads meetings, drives discussions, and ensures decisions are taken concerning project/trial-specific medical writing issues
  • Resolves document content issues and questions arising during the writing process
  • Handles numerous tasks simultaneously and is able to navigate some degree of uncertainty
  • Maintains up-to-date knowledge and understanding of the laws, regulations, industry standards, and company policies/procedures relevant to Medical Writing. Remains current with respect to the literature on Novo Nordisk therapeutic areas and competitor products

 

Physical Requirements