Senior Medical Writer
Skills
BrochuresCTRContract Research OrganizationHealth PromotionInvestigator BrochuresLeadershipRegulatory Requirements
What the job involves
The main requirements, responsibilities and hiring steps.
Requirements
- Bachelor's degree in a scientific discipline or equivalent relevant qualification required
- Advanced degree preferred
- 5+ years of regulatory writing experience
- Experience in the pharmaceutical or CRO industry
- Required experience managing complex medical writing projects
- Knowledge of regulatory guidelines and drug development processes
- Strong organizational leadership interpersonal and communication skills
- Understanding of quality control and compliance processes
- Self-motivated adaptable and able to work independently
- EU CTR experience preferred
Nice to have
- Leadership
- Independent decision making
- Problem solving
- Adaptable
- Self-motivated
Day to day
- Write and edit clinical and regulatory documents such as clinical study reports protocols investigator brochures and regulatory submissions
- Collaborate with cross-functional teams to collect accurate information and ensure documents are complete and compliant
- Manage timelines deliverables and quality while mentoring junior medical writers and supporting complex projects