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Warsaw, IN, US

Medical Safety Specialist (Warsaw, IN - 1 of 2 positions)-5467121214

Description

DePuy Synthes, a member of the Johnson & Johnson Family of Companies is recruiting for a Medical Safety Specialist. This position can be located in Raynham, MA or Warsaw, IN.

DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies will offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in today's evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

The Medical Safety Specialist insures that reports of safety information are documented, processed and reported following Company guidelines, internal business practices, and regulatory guidance to ensure compliance with worldwide safety regulations and corporate policies. This position will provide timely and careful documentation and investigation into reported incidents and provide the company with up-to-date safety information on products.

The Medical Safety Specialist will have responsibility for the following areas: Medical Safety Issues Management Support - manage medical safety issues and medical complaint/adverse event investigation and follow-up; Medical Input to Health Risk Assessment - e.g., FMEA, risk analyses, product inserts, literature reviews, historical/product inquiry data, and clinical readiness review, etc; and Post-Market Surveillance Support - product safety performance report preparation and communicating business related issues or opportunities to next management level.

Qualifications


A minimum of an RN, PharmD or MD with a minimum of 4 years of experience in therapeutic area (joints/neurology/sports/spine/trauma); or a Certified Physicians Assistant with a minimum of 4 years of experience in therapeutic area (joints/neuro/sports/spine/trauma) is required for this position. A minimum of 2 years of experience in the Pharmaceutical or Medical Device Industry is preferred.

Candidates for this position must possess medical knowledge of adverse events associated with medical procedures. Knowledge of regulatory requirements for the handling of adverse events/complaints is preferred.

Knowledge of medical device risk management processes is preferred as is knowledge and experience of common biostatistical methods. Broad knowledge of orthopaedic or neurological products and clinical applications of such products is also preferred.

Strong verbal and written communication skills, the ability to multi-task, effective time management skills and strong organizational skills are required, as is proficiency with the Microsoft Office suite of products. Medical writing and presentation skills are preferred.

BE VITAL in your career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-Indiana-Warsaw
Organization: DePuy Synthes, LLC (6149)