The Panther Group has an immediate need for a REMOTE Senior Medical Writer for a contract position. SENIOR MEDICAL WRITER
SUMMARY :
The Senior Medical Writer (SMW) will work independently and with team members to write and review the content of within-scope documents.
These may include CSRs, protocols, protocol amendments, ICFs, narratives, IBs and IB updates in a variety of therapeutic areas.
The SMW is responsible for document development (eg driving meetings, strategy discussions, timing) and is expected to resolve issues and escalate problems as necessary.
The SMW is also responsible for tracking projects and for adhering to regulatory guidelines and document standards.
ESSENTIAL FUNCTIONS :
Works independently and with team members to create and review the content of within-scope documents. These may include CSRs, Protocols, protocol amendments, ICFs, narratives, IBs and IB updates in a variety of therapeutic areas.
The Medical Writer is expected to drive document development, track deliverables and ensure timely document completion.
- Writes or contributes to other Regulatory documents such as Clinical Summaries and Briefing Documents.
- Represents Medical Writing at project meetings ? Drives document development;
- Articulates document strategy and timelines;
- Understands decision-makers and works to keep discussions focused.
- Synthesizes key messages and presents clear, accurate text for discussion.
- Solves problems, fosters collaboration, resolves conflict
REQUIREMENTS :
- 12+ years of experience, preferred
- Ability to work independently
- Strong knowledge of regulations / guidelines required
- Scientific and technical reading, writing and editing skills required.
- Well-developed organizational, interpersonal and communication skills, and the ability to develop and present varied and unique ideas.
- Good working knowledge of MS WORD, Adobe Acrobat, Project, PowerPoint and use of one or more electronic document management systems
EDUCATION :
- BA or BS Advance Degree
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