Principal Regulatory Medical Writer
MMS
Lead regulatory medical writing at MMS, applying exceptional writing skills and clinical data understanding to complex development documents. Work independently with clients and project teams.
The Principal Medical Writer evaluates medical literature and interprets evidence for scientifically rigorous study design. You will write clinical protocols, investigator brochures, clinical study reports, consent forms, and integrated summaries. The work also includes Module 2 documents, presentations, and journal publications.
Key Responsibilities:
- Evaluate medical literature for rigor, significance, and bias
- Write and edit clinical development and regulatory documents
- Maintain assignment timelines and workflow
- Coordinate projects directly with clients and contributors
- Mentor medical writers and project team members
Requirements:
- Scientific, medical, or clinical degree required
- At least six years of regulatory writing experience
- Lead-author clinical study protocol experience
- Experience leading teams under aggressive timelines
- Expert proficiency with Microsoft Word, Excel, and PowerPoint
Bring regulatory writing expertise, clinical study leadership, and strong organization to principal medical writing assignments at MMS.
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