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The Panther Group
https://www.thepanthergrp.com/wp-content/uploads/2022/03/sm-logo-200x200-1.png
https://www.thepanthergrp.com
https://www.thepanthergrp.com
USD
108.00
HOUR
true
Donnarae Szaban
Senior Medical Writer
Posted: 08/19/2024
2024-08-19
2024-10-07
Employment Type:
Contract
Job Number: 42316
Pay Rate: 108.00
Job Description
The Panther Group has an immediate need for a REMOTE Senior Medical Writer for a contract position.Â
SENIOR MEDICAL WRITER
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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. Â The SMW is also responsible for tracking projects and for adhering to regulatory guidelines and document standards.
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 ESSENTIAL FUNCTIONS:
   ◦ Articulates document strategy and timelines;
   ◦ Understands decision-makers and works to keep discussions focused.
   ◦ Synthesizes key messages and presents clear, accurate text for discussion.
REQUIREMENTS:
EDUCATION:
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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. Â The SMW is also responsible for tracking projects and for adhering to regulatory guidelines and document standards.
Â
 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
   ◦ 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
Meet Your Recruiter
Donnarae Szaban
Client Success Manager
Donnarae is a Client Success Manager that on works with a few of The Panther Group’s enterprise clients.
I have the pleasure of not only recruiting but ensuring all our clients’ needs are taken care on a day-to-day basis.
I have over 20 years’ experience in staffing and managing client relations and my goal is making sure everyone is beyond satisfied with their experience at The Panther Group.
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