The purpose of the Medical Writer is to provide medical writing and research services in support of Regulatory activities, Clinical Research activities, product risk/benefit assessments, and innovation.
Key Responsibilities
- Prepare clinical evaluation reports for submission to regulatory bodies to support new product registrations or continuing registrations.
- Perform data analysis of clinical outcomes data from internal and external sources.
- Perform literature reviews according to recognized scientific methodologies.
- Work with other functional areas to feed back the analysis of post-market information into Risk Management and the Design and Development process.
- Develop and support risk/benefit analyses.
- Independently manage multiple medium to large scale writing/research projects.
- Ensuring that company procedures, processes and documentation meet the required guidelines for maintaining FDA compliance and ISO/EC/CMDR certification, including the application of Design Control and Risk Management processes.
- Participate as needed in the complaint handling, corrective and preventive action and internal quality audit processes.
Providing knowledge and support to the company’s different business units to enable operation within company and regulatory guidelines. - Assisting and supporting other employees, teams, and sales personnel as necessary.
- Practice Exactech’s Values.
- Know and apply the Quality System and any appropriate Federal and International standards
Skills Knowledge and Expertise
Education
Bachelor’s Degree in a related field from an accredited institution required; Master’s Degree preferred
Experience
• Medical/Technical writing skills required
• Experience in systematic literature review required
• Experience in medical devices preferred
• Experience developing and documenting State of the Art reviews for medical products preferred.
Functional/Technical Knowledge, Skills and Abilities Required:
• Working knowledge of Windows based office productivity tools including word processor and spreadsheet
Bachelor’s Degree in a related field from an accredited institution required; Master’s Degree preferred
Experience
• Medical/Technical writing skills required
• Experience in systematic literature review required
• Experience in medical devices preferred
• Experience developing and documenting State of the Art reviews for medical products preferred.
Functional/Technical Knowledge, Skills and Abilities Required:
• Working knowledge of Windows based office productivity tools including word processor and spreadsheet