Director, Medical Affairs - (Job Number: 0809850)

Director, Medical Affairs - (Job Number: 0809850) DescriptionEthicon Endo-Surgery, Inc., a member of Johnson && Johnson's Family of Companies, is currently recruiting for a Director, Medical Affairs, located in Cincinnati, OH. Ethicon Endo-Surgery, Inc. develops and markets advanced medical devices for minimally invasive and open surgical procedures. The company focuses on procedure-enabling devices for the interventional diagnosis and treatment of conditions in general and bariatric surgery, as well as gastrointestinal health, gynecology and surgical oncology. The Director, Medical Affairs is responsible for defining and growing the Medical Affairs area at Ethicon-Endo Surgery. This person will be responsible for the medical aspects of lifecycle management for Ethicon-Endo products. This position presents the opportunity to integrate medical knowledge and clinical based evidence throughout the organization using a lifecycle adviser model. The Director, Medical Affairs will manage a staff of other medical affairs professionals. In this capacity, he/she will be responsible for worldwide quality, medical and liability issues (EES/ASP) support. This will include quality board/health hazard assessment; complaint investigation and follow-up; copy clearance and claims review and legal and regulatory consultation (depositions, etc). Additionally, the Director, Medical Affairs will influence and consult with R&&D and new product development. This will encompass preclinical product performance and validation; and TDR support (e.g., FMEA, risk analyses, product inserts, literature reviews, and historical/products inquiry data). The Director, Medical Affairs will be responsible for clinical operation support. This will include training and technique development/review strategies, medical monitoring, safety data analysis, and trial design input. Also, this role will oversee new technology and procedure assessment. This includes assessment of new technologies and due diligence for business development; evaluation of medical/surgical application of new technologies and procedures; and focus on guiding new franchise areas such as GI/Ther Endo and Oncology. Other key responsibilities will include management responsibility for organizational structure and professional development of Medical Affairs associates; interact with key opinion leaders, medical societies and medical personnel in collaborative relationships; direct Medical Affairs to successfully achieve registration of key products with the FDA; partner with Clinical Management Team to execute clinical studies under GCP (Good Clinical Practice) standards; maintain knowledge and awareness of product inquiries and MDR (Medical Device Reporting) as they pertain to the products; transmitting this information to appropriate teams or individuals, and keeping the company informed as to safety considerations associated with our products; assess the implications of product malfunction, product design and potential user error as to the safety of the patient; ensure Medical Affairs works closely with Franchise Development, Business Development, R&&D, QA, and Regulatory Affairs to provide timely and expert support to product development; ensure Medical Affairs works closely with global commercial functions to implement a research strategy that will facilitate development of new products and procedures in all specialties cited in the EES Strategic Plan; ensure Medical Affairs has mapped out all critical processes and is employing process excellence for continuous improvement; and lead efforts to create an environment that encourages and recognizes creativity, innovation, teamwork, risk taking and empowerment. Other responsibilities may be assigned. This position requires an MD degree. Board Certified/Board Eligible in Surgery or Procedure-Based Specialty strongly preferred. A minimum of 2 years of clinical trials or medical affairs experience in the medical devices or pharmaceutical industry or CRO is required. A minimum of 2 years in a direct management role is strongly preferred. Having worked in a global capacity is an asset. Excellent oral and written communication skills are required. Success working in a matrix environment is a strong plus. Must be a strategic thinker with excellent interpersonal skills and influencing skills. An understanding of FDA regulatory environment for devices and/or drugs is required. Experience with health risk assessment, facilitation of medical expert panels, clinical carepath mapping and business and clinical due diligence is preferred. This position will require from 20-40% travel (domestic and international). If you want to explore the many small-company environments behind the big-company impact of the Johnson && Johnson Family of Companies, bid on this position today! Apply Now