Manager, Medical Operations (Cincinnati, Ohio)-1610141014
Description
Ethicon, a member of the Johnson & Johnson Family of Companies, is currently recruiting for a Manager, Medical Operations, to be located in Cincinnati, Ohio.
The Ethicon business offers a broad range of products, platforms and technologies-including sutures, hemostatic agents, surgical staplers, clip appliers, trocars and synthetic mesh devices-that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women's health conditions, hernias, cancer and obesity. The Ethicon business combines products and services of two market leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and electiveness of open surgery. Ethicon Endo-Surgery, Inc. was created 20 years ago in Cincinnati, Ohio, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today.
The Medical Operations Manager’s primary responsibility will be to collaborate closely with the medical directors, serving as a ‘physician extender’ in support of business responsibilities. This individual’s responsibilities include, but are not limited to: oversee literature review analysis and conclusions for CERs (Clinical Reviews); provide review of CERs and assist in preparation of periodic safety reports for biologic products; provide medical expertise perspective; provide initial hands on management of publications and maintain timelines; research, prepare and document responses to Medical Information Requests from Healthcare providers, prepare and maintain Standard Medical Responses; provide clinical perspective for copy review; assist in reviewing of product risk evaluation (PRE) documents, draft the health hazard evaluation and obtain additional information prior to final medical review; prepare and/or manage presentations and manuscripts around clinical data as well as medical and scientific information.
The Medical Director will be a real time resource to the individual in this position and will assist in providing oversight and guidance relating to activities. The Medical Operations Manager will need to ensure effective communication with the Medical Director(s). S/he will also assist in the coordination and prioritization of activities to meet business deliverable timelines. This individual may also assist site leadership on other aspects of Medical Operations as the need arises.
The Medical Operations Manager actively partners with cross-functional business partners such as Marketing, Post Market Surveillance, Design Quality Engineers, R&D, Clinical development and Regulatory Affairs, etc.
Qualifications
A minimum of a Physician's Assistant, Nurse Practitioner, BSN or other Health Science degree (e.g., PhD in Health Science area) is required. An Advanced degree is preferred. A minimum of 7 years of clinical experience with direct patient contact (settings can be in research, hospital, industry or other related area) is required. Clinical experience with medical devices is preferred. Knowledge of clinical trial design, evidence generation, adverse event reporting and surgical practices/principles are preferred. Demonstrated knowledge and experience in quality compliance, regulatory compliance, and healthcare compliance are preferred. Operating room or critical care experience is preferable.
Excellent communication (presentation and writing) skills are required when interacting with individuals at different professional levels. Excellent presentation skills, preferably with a history of presentations at the regional or national level, are preferred. Experience in performing targeted searches of the published medical literature in PubMed, OVID or Scopus is desired. Proven leadership and proven ability to drive results working with a team of individuals is required. Strong computer skills including presentation preparation, document management, and other digital product preparation is required.
Ability to travel approximately 15% of the time, including internationally is required.
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Primary Location:North America-United States-Ohio-Cincinnati
Organization: Ethicon Endo Surgery Inc (6041)
Travel:Yes, 10 % of the Time
Job Function: Medical Affairs
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