61 The medical writer develops, translates or supports a variety of documents that include but not limited to:
o Investigational New Drug (IND), New Drug Applications (NDA), and/or Biologic License Applications (BLA)
o Clinical study protocols and amendments
o Investigator Brochures
o Clinical study reports
o Protocol procedure manuals
o Informed consent forms
o Statistical analysis plans
o Powerpoint presentations
o Scientific manuscripts and/or posters
61 The clinical medical writer works collaborative with Regulatory Affairs (RA) and Medical Affairs (MA) to support written documents for eventual product registration that would enable review by both English and Chinese language audiences (eg, strategic partners, United States Food and Drug Administration, European Medicines Agency as well as the National Medical Products Administration [China]) for either pharmaceutical or medical device applications.
61 Interacts with department head and key stakeholders in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
61 Adheres to established company standard operating procedures (SOP), regulatory guidance, and established templates when completing medical writing projects, on-time, and on-budget.
61 Continues professional development to keep pace with regulatory guidance and company expectations that affect medical writing and to improve skills
61 Completes required tasks within specified timeframes.
61 Performs other work-related duties as assigned. Minimal travel may be required (eg, investigator meeting) less than 15% of time.
Qualifications
61 Master’s degree or higher in clinical medicine, basic medicine, pharmacy or other related major. Overseas study background and doctoral degree are preferred.
61 Greater than 3 years of medical writing experience in a pharmaceutical company or contract research organization (CRO) with more than 1 year or project management or medical writing preferred.
61 Fluent in Chinese and English (reading/writing/listening/speaking), and English proficiency is equivalent to College English Test (CET) level 6 or above.
61 Computer: proficient in using Word, Excel, Powerpoint, Outlook, and other software
61 Excellent verbal and written communication skills with demonstrated ability to work collaboratively in a matrix work environment