Writer, Clinical Evaluation

Job Summary – Responsible for compiling technical, clinical, sales & marketing, and peer review publications for up-classification submissions to European Union (EU) regulatory bodies. Will summarize information and write justifications for product use based on clinical research and peer review publications. Assist in submission of final up-classification documents for Zimmer’s product lines including: reconstruction, trauma, and biologics. General Functions – Identify and compile pertinent internal and external technical, clinical, sales & marketing, and peer review publications. Build EU document using relevant information from compiled information. Summarize findings based on EU requirement for usability of product or product line. Work with Clinical, Regulatory, Sales, and Marketing groups to validate and approve content of final up-classification document. Provide verbal updates and written reports regarding progress of projects on a monthly basis. Manage the Product Reclassification archives and provide bibliographic research and documentation as a service to clinicians, staff and other personnel. Manage and/or perform additional tasks and projects, as assigned by the Clinical Outcomes Manager and executive management. Assist in the preparation and management of departmental projects, as requested. This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADAExpected Areas of Competence (i.e. KSAs) – Excellent written and verbal communications skills. Demonstrated bibliographic research and editorial skills. Strong organizational, attention to detail skills, and proofreading skills. Strong ability to organize, interpret and disseminate relative product information. Proficiency in MS Office applications, EndNote and/or Reference Manager. Basic understanding with FDA compliance for medical devices. Demonstrated project management skills.Education Requirements – B.S. with a background in biological sciences/joint reconstruction/medical devices or equivalent work experience. Licenses/Certifications – Skill Requirements – Clinical or regulatory experience a plus.Travel Requirements – less than 10%Education: BachelorsJob Level: 3 - 5 yearsPercent Travel: 1-10%