Principal Medical Writer

Location
Basking Ridge, NJ, United States
Posted
Apr 12, 2021
Ref
24015BR
Required Education
Other
Position Type
Full time
The Principal Medical Writer will be responsible for collaborating closely with the appropriate matrixed team members to craft and review content of documents, and to follow up with other functional groups. This includes materials needed for document completion, reviewing documents related to the CSR, such as the Statistical Analysis Plan and draft tables, figures and listings, and ensuring that they provide the appropriate information/data for a CSR, tracking all documents in a therapeutic area. You will supervise more junior writers working on documents in their therapeutic area, and leading the Medical Writing effort in a clinical filing. You will be responsible for ensuring adherence to department guidelines, templates, SOPs, and regulatory guidelines for all Medical Writing documents provided for their therapeutic area. We expect you will work independently writing CSRs, CSPs, CSP amendments, IBs and IB updates, and Clinical Summaries in a variety of therapeutic areas. Work closely with Medical Directors, Biostatisticians and/or regulatory liaisons to develop high quality clinical documents.

In this role, a typical day might include the following:

Working with the clinical team, you will be responsible for writing following documents:
  • Clinical Study Protocols
  • Clinical Study Protocol Amendments
  • Clinical Study Reports
  • Investigator brochures
  • Clinical Summaries
  • Other documents, as needed

We expect you will:
  • Have written CSRs, clinical protocols, clinical protocol amendments, IBs, IB updates and clinical summaries for NDA/BLA/MAA, etc.
  • Understand the general document content for each clinical document type, how the individual document types fit into a filing and feed from one to the next, and how to message appropriately across the clinical documents in a filing.
  • Expected to resolve issues and advance problems, as necessary
  • Contribute to document strategy in a therapeutic area.
  • Lead other writers in large projects, providing framework for document content.
  • Participate actively in meetings; communicate opinions and influence decisions;
  • Be able to identify the accurate parties for a document content decision, and if a discussion is faltering, bring it back on track with minimal fuss.
  • Follow a discussion to its conclusion, synthesize the message, and present clear accurate prose quickly.
  • We expect you will show managerial courage in a matrixed organization
  • Have a solid understanding of PDF, and Project. Skilled in use of MS WORD. Has used 1 or more EDM systems
This role might be for you if:

Bachelor's Degree and 8-10 years relevant proven experience to include a minimum of 8+ years Medical Writing experience (relevant advanced degree may offset some of the experience requirement)

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need. #LI-EG1