Medical Writer (China)
Department: Clinical/Medical - Medical Science
Job Title: Medical Writer
Report to: Clinical Research Physician Director
- Responsible for implementing and maintaining the effectiveness of the quality system.
- Serves as the Medical Writing representative on product teams. Coordinates all activities related to the preparation and compilation of data and information into a single comprehensive package for new and revised domestic and international regulatory submissions, market labeling, clinical labeling, troubleshooting guides, training aids, and customer communications for diagnostic assays and instruments. Communicates deliverables needed and writing process to team members.
- Accesses resource needs as timelines progress and communicates those needs to management.
- Utilizes submission templates (if available) and format/style guidelines established by Medical Writing.
- Obtains relevant product data and information. Assesses accuracy of information.
- Understands sources of information. Converts relevant product data and information into a form that meets submission requirements. Reviews, circulates, edits, assembles, inspects, and duplicates product submissions.
- Uses ADD manufacturing/ testing documentation systems. Determines format for submissions and documents.
- Interprets data and verifies that results are consistent with protocols. Confirms completeness of information to be presented.
- Confirms label and package insert claims are supported by and consistent with data presented in the submissions.
- Acts as interface to resolve issues and questions arising during writing process.
- Arranges and conducts review meetings with teams on submission and related labeling.
- Coordinates responses to inquiries, questions, and deficiencies received from submission reviewers both in the US and internationally.
- Interprets and explains data generated from a variety of sources, including internal experiments, research documentation, charts, graphs, and tables.
- Explains the data in a manner consistent with the target audience and regulatory requirements.
- May recommend and implement process improvements.
- Responsible for implementing and maintaining the effectiveness of the Quality System.
- Bachelor’s degree in Science, Medical Technology, English, or equivalent experience.
- Minimum 4-6 years relevant professional experience, in a related area such as R&D, Technical Product Development, Quality, Regulatory Affairs, Clinical Research, or Medical Writing.
- 4 years writing experience as a medical writer in the health care industry preferred.
- 2-4 years’ experience in experimental design and data interpretation preferred.
- Knowledge of Abbott Molecular Division products desirable. Good written and oral communication skills.
- Superior attention to detail. Ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity, and accuracy.
- Fluent in word processing, flow diagrams and spreadsheets. Good working knowledge of personal computer software programs in Windows environment.
- Good communication, interpersonal, and team skills.
- Ability to critically review own work before sending out for internal/external review by team.