MI
Regulatory Writing Specialist (Clinical)
Med Communications International
Contract type
Ongoing
Work mode
Remote · Europe
Experience
Mid-level · 3+ years
Job description
A Regulatory Writing Specialist role focused on authoring clinical regulatory documents, preparing regulatory submissions, and performing document quality control for pharmaceutical clients. The position also involves client-facing project management of deliverables.
At a glance
- Work mode
- Remote · Europe
- Languages
- English
What you'll do
- Author and develop Clinical Study Reports (CSRs), clinical study protocols, Investigator's Brochures (IBs), briefing documents, briefing books, and other clinical regulatory documents.
- Prepare and support documentation for IND, NDA, BLA, and MAA submissions, including CTD Module 2 documents such as the Clinical Overview (Module 2.5) and Clinical Summary (Module 2.7).
- Where applicable, develop nonclinical summaries, overviews, and supporting documentation, including CTD Module 2.4, Module 2.6, and Module 4 documents.
- Work with clinical evidence reports, scientific source materials, statistical outputs, and, where required, Chemistry, Manufacturing and Controls (CMC) documentation.
- Conduct QC reviews to verify scientific accuracy, consistency, references, data, tables, figures, formatting, and compliance with project-specific requirements.
- Liaise with clients and cross-functional teams, manage review comments and document revisions, and coordinate deliverables to meet agreed timelines.
What we're looking for
- At least 3 years of hands-on pharmaceutical regulatory writing experience, with substantive document authorship rather than contribution or review alone.
- Clinical regulatory writing experience.
- Direct authorship of at least 3 different types of regulatory documents, such as CSRs, clinical protocols, Investigator's Brochures, briefing documents, or CTD Module 2 documents.
- Client-facing and/or project management experience.
- Practical document QC review experience and excellent attention to detail.
- Advanced Microsoft Word skills, including complex formatting, styles, tracked changes, tables, and document review.
- Excellent written English, scientific communication, and organisational skills.
Nice to have
- PhD, PharmD, MD, or another relevant scientific or medical qualification.
- Nonclinical or preclinical regulatory writing experience, particularly CTD Module 2.4, Module 2.6, or Module 4.
- Scientific, pharmaceutical, clinical, or research experience.
- Familiarity with CMC documentation and regulatory submission requirements.
- Experience with Veeva Vault, SharePoint, PleaseReview, or similar document management platforms.
- Basic understanding of biostatistics and clinical study data interpretation.
- Familiarity with ICH guidelines and FDA or EMA regulatory requirements.