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Director, Medical Affairs- Orthopedic Tissue Technologies

Overview
Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, reconstructive and general surgery, and regenerative wound care.
Integra's orthopedic products include devices and implants for foot and ankle, hand and wrist, shoulder and elbow, tendon and peripheral nerve protection and repair. Integra is a leader in neurosurgery, offering a broad portfolio of implants, devices, instruments and systems used in neurosurgery, neuromonitoring, neurotrauma, and related critical care. Integra's Tissue Technologies is an in-patient and outpatient Regenerative product portfolio, which includes products for wound care, burns, abdominal reconstruction, and plastic & reconstructive surgery. In the United States, Integra is a leading provider of surgical instruments to hospitals, surgery centers and alternate care sites, including physician and dental offices.
Founded in 1989 Integra is headquartered in Plainsboro, New Jersey and has over 3,300 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART."
Responsibilities
Integra's orthopedic products include devices and implants for foot and ankle, hand and wrist, shoulder and elbow, tendon and peripheral nerve protection and repair, and wound repair.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Sets and communicates a strategy and vision for Integra's global medical affairs organization in collaboration with the ELT.
Executes the yearly strategic and operational objectives for medical affairs.
Sets a framework for results oriented approach of medical affairs activities in partnership with regional and divisional stakeholders, including the Global Franchise Leads and business presidents.
Oversees compliant and cost effective development and use of clinical evidence in support of product development, product approvals/registrations, product positioning & claims, coverage/reimbursement, and post-marketing surveillance.
Ensures that effective leadership and appropriate resources are utilized in order to meet objectives and assures technical excellence of all staff within the medical affairs functions.
Drives the development and maintenance of corporate standard operating procedures to allow adherence to compliance requirements, as well as setting a framework for results oriented approach of medical affairs activities in partnership with regional and divisional stakeholders.
Directs the development of systems, practices and processes to ensure a compliant and collaborative framework for business support with adequate interpretation and use of medical information and clinical evidence in:
product strategy (VOC, unmet needs),
product development (design input, risk assessment, product validation)
product marketing (messaging, KOL relations, clinical training, customer inquiries)
medical device vigilance such as, evaluation of adverse events and post-market surveillance reports, and support of Health Hazard Evaluations.
Develops strategy, framework, resources, and oversight for providing medical input into:
the translation of VOC / unmet needs into medically relevant product design specifications
the development, review and approval of company sponsored clinical studies, investigator initiated studies and publication planning.
medical writing activities including clinical evaluation reports, clinical sections of regulatory submissions, white papers and publications, and clinical training materials
product post-market surveillance activities
internal (e.g. clinical sales specialists) and external (CME courses, labs, ...) training programs
Develops strategy, framework, resources, oversight and execution of all medical education activities to internal and external stakeholders on a global basis
Manages Medical Affairs resources leading product risk assessment and product validation activities, and providing support of other product development activities.
Aligns the compliant generation and dissemination of medical information with our brand strategies, in collaboration with key stakeholders.
Develops and manages the processes internal and external medical information requests, including off-label requests.
Builds strong professional relationships with KOLs. Engages in consulting agreements with surgeons for input into medical affairs activities. Supports development and execution of KOL development and KOL relations programs i.e. advisory boards, speakers' bureau, medical safety board etc., in collaboration with divisional stakeholders, in support of product development, post-market support and surveillance and medical education.
Supports building value proposition (EBM / VBM) strategies to patients & physicians, in collaboration with marketing and (enterprise) sales functions, including the development of publication plans and medical education activities. Provides oversight of medical information in promotional materials.
Drives alignment & coordination with other centralized related functions (Product Development, Clinical Operations, Medical Writing, HEOR) for the collection and use of medical information and clinical evidence.
Leads stakeholder management, working across divisions and geographies and building internal and external networks globally.
Represents the company in scientific organizations and industry associations, and regulatory group meetings regarding medical expertise.
Assists in assessing internal product development strategies and business development opportunities.
Leads stakeholder management, working across divisions and geographies and building internal and external networks globally.
Supports the CSO office with external stakeholder interactions to improve and broaden Integra's scientific, medical and business image.
Qualifications? MD or DO with background in Medical Affairs management preferred. Ten years industry experience (pharma or medical devices) required, with a minimum of five years in a medical affairs function.? PhD, PharmD, PA-C, NP, RN in related science/medical field and significant industry experience in medical affairs (pharma or medical devices) will be considered.



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