Lead regulatory medical writing at MMS through clinical data interpretation, document authorship, and client coordination for complex research projects. Work independently under minimal supervision.
As Principal Medical Writer, you will critically evaluate medical literature and author clinical development documents. The work spans protocols, investigator brochures, clinical study reports, consent forms, integrated summaries, Module 2 documents, presentations, and publications. You will also mentor writers and manage project contributions.
Key Responsibilities:
- Evaluate medical literature for rigor, significance, bias, and study design
- Write and edit clinical development and regulatory documents
- Coordinate projects directly and independently with clients
- Maintain assignment timelines, workflows, and timely completion
- Mentor medical writers and project team members
Requirements:
- Scientific, medical, clinical, or related degree required
- At least six years of regulatory writing experience
- Substantial lead-author clinical study protocol experience
- Experience leading teams and authoring regulatory documents
- Expertise in Microsoft Word, Excel, PowerPoint, and related tools
Bring exceptional regulatory writing, clinical data understanding, and project leadership to Principal Medical Writer work at MMS.
