Senior Medical Writer
Thermo Fisher Scientific View all jobs
- Shanghai
- Permanent
- Full-time
As a Principal Medical Writer, you will serve as the primary author by writing and providing input on routine documents such as clinical study reports and study protocols and summarizes data from clinical studies.What You'll Do:
- Provide high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients.
- As the lead writer, review documents for the team and provide training and guidance to junior team members.
- Provide advice on document development strategy, regulations and industry best practices.
- Demonstrate subject matter and therapeutic area expertise.
- Act as backup program manager.
- Collaborate with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence.
- Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred
- Experience within regulatory medical writing (comparable to 8+ years) required
- Experience working in the pharmaceutical/CRO industry preferred
- Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous.
- Significant knowledge of global, regional, national and other document development guidelines
- In-depth knowledge in one or more specialty areas such as preclinical, therapeutic, regulatory, submissions, communications, etc.
- Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills
- Excellent project management skills
- Advanced interpersonal, oral and written communication, and presentation skills
- Excellent negotiation skills
- Excellent judgment; high degree of independence in decision making and problem solving
- Ability to mentor and lead junior level staff.