Job Code: CNCD05
Position: Medical Writer
Department Clinical Development – Medical Science
Reports to: Medical Director, Asia
Location: Taicang Office/ Remote, China
The primary goal of the Medical Writer is to communicate complex medical information in clear and compliant writing. Work with clinical and pre-clinical teams to understand the nature of the scientific work that they will be covering. Assess data or products using medical expertise, and quickly develop expertise in new areas as needed for their writing. Conduct comprehensive literature searches to enhance background understanding and evaluate and analyze the information.
- Compile, write, and edit medical writing deliverables covering all phases of clinical and pre-clinical research for submission to regulatory agencies.
- Writings include, but are not limited to, comprehensive clinical study reports, study protocols, annual reports, investigator brochures, risk/benefit analysis and integrated summaries from raw data.
- The writing is also used in publications or medical journals, or for internal company use. Also write scientific copy for a broader audience, including scientific liaisons, healthcare professionals, and pharmaceutical representatives.
- Prepare abstracts, scientific exhibits, posters, and verbal presentations.
- A key task is to be sure that all deliverables are in accordance with regulations, standards, and guidelines. The regulatory documents must meet GLPs, and GCPs, the Connect writing style guide, and often the company template.
- Must understand the levels of evidence required to achieve, marketing and regulatory goals.
- Bachelor’s degree in a Medical, biomedical, pharmacy, nursing field or English. Scientific degree with significant drug development experience is required. D or Ph.D. is strongly preferred.
- 3-5 years clinical drug development or medical writer experience within a pharmaceutical company or CRO Company.
- Publication experience is preferred.
- FDA submission experience will be an asset.
- Expertise in the immunology therapeutic area and knowledge of relevant products is highly desired.
Skills and Attributes:
- Knowledge of current literature, emerging science, technological developments, and medical trends.
- Extensive knowledge of English grammar with a familiarity of a standard AMA style guide.
- Ability to communicate scientific or medical information in a clear and concise manner.
- Proficiency in Word, Excel, PowerPoint, email, and the Internet.
- Familiarity with the principles of clinical research.
- Ability to interpret and present clinical data and other complex information.
- Aware of current industry practices and regulatory requirements that affect medical writing.