Company: Regeneron Pharmaceuticals, Inc.
Location: Basking Ridge
Posted on: November 22, 2021
Overseen by a more senior staff member, the Medical Writer will
liaise with the appropriate matrixed team members to shape and
review content of documents, and to follow up with other functional
groups for materials needed for document completion. The Medical
Writer will be expected to resolve issues and escalate problems, as
necessary. The individual in this position will write CSRs, CSPs,
CSP amendments, narratives, IBs and IB updates in a variety of
therapeutic areas. Training on Clinical Summaries and other
regulatory documents may be provided.JOB RESPONSIBILITIES:
- Working with the clinical teams, the Medical Writer will be
responsible for writing Clinical Study Protocols, Clinical Study
Protocol Amendments, Clinical Study Reports, Narratives,
Investigator's Brochures. The work will be overseen (reviewed and
edited, as necessary) by a more senior staff member, however, the
Medical Writer is expected to drive the project, track
deliverables, and ensure timely completion.
- Liaises with study director and/or medical monitors to shape
and review content of documents. Follows up with other functional
groups for materials needed for document completion.
- Tracks writing projects, and ensures adherence to regulatory
guidelines and department document standards.
- Ensures maintenance of document standardization through use of
model documents/templates and appropriate peer review.
- Updates job knowledge by tracking changes in writing
guidelines; participates in educational opportunities, reads
professional publications and maintains personal networks.Education
- Bachelor's degree (advanced degree preferred)Experience
- Minimum of 1+ years of industry experience
- Working knowledge of the clinical research process and
regulations/guidelines required. Scientific and technical reading,
writing and editing skills required.
- Strong organizational, interpersonal and written communication
skills. Must be able to communicate effectively in large or small
group settings. Effective influence and relationship management
- 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.
- Have strong organizational, interpersonal and communication
skills, and be able to develop and present varied and unique
- Expected to have a good working knowledge of MS WORD, Adobe
Acrobat, and use of one or more EDM systems.
Keywords: Regeneron Pharmaceuticals, Inc., Newark , Medical Writer, Healthcare , Basking Ridge, New Jersey
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