RegScribe Consulting
MEDICAL WRITER REGULATORY
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RegScribe Consulting is supporting an international client in the search for an experienced Freelance Regulatory Medical Writer to support upcoming regulatory writing projects.
We are seeking a skilled writer who can work independently while collaborating effectively with cross-functional and international teams.
Key Requirements
- Minimum 1 year of independent regulatory medical writing experience
- Demonstrable experience developing and/or contributing to regulatory and clinical documents
- Strong understanding of regulatory writing standards, document structure, and scientific accuracy
- Familiarity with relevant ICH guidelines and major regulatory authority expectations
- Excellent written and spoken English
- Strong ability to interpret and communicate complex clinical and scientific information
- Excellent attention to detail, organization, and deadline management
- Ability to work independently and collaborate effectively within multidisciplinary teams
- A portfolio or examples of previous regulatory writing work is required
- Previous regulatory or clinical writing experience in Ophthalmology will be a strong advantage.
- Experience with documents such as clinical study reports (CSRs), protocols, investigator’s brochures (IBs), clinical summaries/overviews, regulatory submission documents, and related clinical development documentation will be valuable.
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How to Apply
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Please submit:
- Updated CV
- Cover letter highlighting your regulatory writing experience
- Portfolio or suitable examples of previous regulatory writing work
- Details of any Ophthalmology experience, where applicable
Applications: info@regscribeconsult.com
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