Senior Medical Writer

MAJOR RESPONSIBILITIES AND DUTIES

1. Coordinate and lead the composition and production of a wide range of different types of documentation concerned with health care and medical topics. The work of a medical writer involves strong skills in such areas not only as writing but also analytical and research skills; as well as some knowledge in the medical field and regulatory policies / requirements for documents used in regulatory submissions.
2. Develop and implement training for medical writers in areas of expertise
3. Serve as an mentor to junior staff members
4. Perform other tasks as directed by the line manager

Qualifications

1. Have strong writing skills and a firm understanding of medical terms. He/She might use diagrams, anatomical images, photographs and charts to explain medical content, so proficiency with word processing software is a must. Researching is a required job skill, hence familiarity with reputable medical journals, regulatory requirements, and clinical research publications is a plus.
2. Be familiar with authority regulations and follow all steps in the submission and approval process.
3. Shall have a minimum of a bachelor's degree in health science. Advanced degree, such as MSc, M.D, Pharm.D. or Ph.D. in health care or a scientific field is a plus.
4. Medical writer experience in pharmaceutical / biotech company or CRO
5. Be proficiency with word processing and other office software
6. Experience in clinical study and relevant documents writing
7. Good communication skills required

Internal-External Relations

1. Internal: HUTCHMED study team, regulatory team
2. External: CRO, Pharmaceutical company