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.
Duties and Responsibilities (Key Deliverables):
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.
Practicing Exactech’s Values.
Know and apply the Quality System and any appropriate Federal and International standards
Job Requirements: Education:
Bachelor’s Degree in a related field from an accredited institution required; Master’s Degree preferred
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.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)