Principal Scientist, Medical Writing

About the role

Author, review, and coordinate medical writing deliverables across the product lifecycle, from clinical development through the post-marketing phase. Prepare and coordinate key clinical and regulatory documents, including clinical trial protocols, protocol amendments, clinical study reports, investigator’s brochures, submission documents, and responses to health authority questions.

What you'll do

• Prepare and coordinate key clinical and regulatory documents, including clinical trial protocols, protocol amendments, clinical study reports, investigator’s brochures
• Work cross-functionally with Clinical Development, Biostatistics, Pharmacovigilance, Regulatory Affairs
• Manage document plans, timelines, review cycles, and stakeholder input to ensure accurate and timely delivery
• Maintain documents and workflows in Veeva Vault or símilar document management systems, ensuring compliance with applicable regulatory requirements, internal procedures

What you need

• 5–9 yrs of experience
• Writing
• Pharmacovigilance
• CRO
• GCP
• Regulatory affairs
• Documentation
• M.Sc or M.Pharm or PhD