Senior Medical Writer
Skills
Educational MaterialsInvestigator BrochuresMarketing Authorisation ApplicationMedical WritingNew Drug ApplicationPremarket ApprovalPresentations
What the job involves
The main requirements, responsibilities and hiring steps.
Requirements
- Advanced degree in health sciences like nursing pharmacy or natural science
- At least 10 years of regulatory or scientific writing experience
- Direct experience with technically complex document preparation for regulatory submissions
- Experience in the pharmaceutical industry
- Global experience in regulatory processes highly preferred
- Ability to collaborate effectively across multidisciplinary departments and interact with clients.
Day to day
- Collaborate with project teams across diverse Regulatory and Scientific Affairs projects
- Research and develop background information for projects
- Write and edit scientific documents including protocols clinical study reports and designation requests
- Ensure high-quality medical writing deliverables through established processes
- Implement project deliverables on time and within budget
- Provide project status reports and interact effectively with clients.