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Catalyst Clinical Research is seeking a Principal Medical Writer to produce and review regulatory and other medical writing deliverables in a remote setting. The ideal candidate should possess significant experience in medical writing, particularly with regulatory documents, and have strong communication and organizational skills.
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Job Summary
The role involves independently authoring and reviewing high-quality regulatory and medical writing deliverables for global submissions.
Candidates will lead a team by managing staff development, performance coaching, and ensuring departmental audit readiness.
The position requires collaboration with data analysts on evidence generation projects while adhering to ICH and regulatory guidelines.
Matching Summary
Match Score: 75
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Catalyst Clinical Research is seeking a Principal Medical Writer to produce and review regulatory and other medical writing deliverables in a remote setting. The ideal candidate should possess significant experience in medical writing, particularly with regulatory documents, and have strong communication and organizational skills.
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Skills & Requirements
Must-have
Authoring regulatory submission documents
5 years core medical writing experience
PharmD, PhD, MD or Life Science degree
Managing departmental staff and performance
Ensuring audit readiness and SOP development
Nice-to-have
Manuscript and publication writing experience
Real-world evidence generation projects
Automation and process improvement initiatives
Thought leadership activities in domain
Flexible writing style across therapeutic areas
Key Requirements
10-11 years total experience in medical writing
Minimum 5 years in core regulatory medical writing
Advanced proficiency in Microsoft Word macros
Doctorate or Master's degree in Life Sciences
Strong project management and organizational skills