RESPONSIBILITIES
The Senior Medical Writer- CER supports and executes general medical writing activities, systematic literature reviews for the generation of Clinical Evaluation Reports (CER) for assigned therapeutic area and projects within R&D Medical Device sector. The high-level activities may include:
- Responsible for the planning and execution of general medical writing activities and systematic literature reviews for assigned therapeutic area
- Collaborates with Operations Team members including Technical Writers, Medical Writers and Project Managers as applicable to gather information (timelines, projects, documents)
- Ensures documents are produced in accordance with procedures, internal and external guidelines (e.g. MDD and MDR), and electronic templates.
- Provides oversight in scientific and medical writing and/or critically edits the deliverables (e.g. protocols and reports) from medical writing staff
- Provides oversight in the development of the Clinical Evaluation Plans, Clinical Evaluation Reports, and Safety Surveillance Report
- Demonstrate exceptional knowledge in CER and win clients’ confidence by understanding their internal processes and helping the client by reducing their involvement in training and oversight of our teams
- Build a strong relationship with client to ensure sustainable growth or our services. Support new business development
- Develops and maintains medical writing procedures, processes, and training program
- Supports Client Engagement team as Medical Writer Lead SME
REQUIRED QUALIFICATIONS:
- B.S., M.S. required; advanced degree preferred (Pharmacy/Life Sciences)
- Minimum of 3 years of related job experience is required for this position
- Experience within the medical device industry and knowledge of clinical evaluation reports requirement, evidence generation, and CER document creation is required
- Strong knowledge of Clinical and Scientific Research Methodology
- Strong knowledge and experience in Professional Medical Writing (Medical/Clinical; Regulatory; and Safety)
- Highly proficient in Microsoft Office Suite and bibliographic software (e.g. Endnote, Reference Manager)
- Excellent communication skills (writing and verbal) in English
- Demonstrated knowledge and experience in quality regulatory compliance, complaint handling, adverse event reporting, medical device risk management processes, and experience with common bio statistical methods is preferred
- Regulatory/Notified Body audit experience is preferred