Senior Principal Medical Writer

We are looking for a Senior Principal Medical Writer to lead the development of complex regulatory submission documents, ensuring scientific rigour and regulatory compliance. This role involves defining document strategy and mentoring writers. Ideal for an experienced professional with strong medical writing expertise in pharma/biotech.

Skills

• regulatory submission
• medical writing
• ctd/ctd-like knowledge
• clinical study report
• investigator’s brochure
• briefing book
• clinical summary
• pharmacovigilance
• regulatory affairs
• statistics
• mentoring
• vendor management
• document management systems
• sharepoint
• standard medical writing templates
• strategic document planning
• cross-functional leadership
• stakeholder management
• negotiation
• quality assurance
• regulatory guidelines
• lifecycle management