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Manager, Medical Affairs, Codman Specialty Surgical

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 is a leader in neurosurgery, offering a broad portfolio of implants, devices, instruments and systems used in neurosurgery, neuromonitoring, neurotrauma, and related critical care. 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.Product strategy & product development support:
Supports the development of strategy and procedures related to Medical Affairs input into product development activities for Neuro activities.
Support the translation of VOC / unmet needs into medically relevant product design specifications
Lead product risk assessment and product validation activities, and providing medical input into other product development activities
Support defining strategy and design of company sponsored clinical studies
Support medical monitoring activities of company sponsored clinical studies, including the organization and oversight of DSMB / CEC activities as required
Collaborate with medical writing team on the generation of clinical evaluation reports, clinical sections of regulatory submissions and clinical training materials
Assist in assessing business development opportunities
Post-market product support:
Collaborates with Integra's Medical Device Safety functions to develop strategy and drive the execution of Medical Affairs input into post-market safety related issues
Provide medical input into medical device vigilance activities such as, evaluation of adverse events, post-market surveillance reports, and support of Health Hazard Evaluations
Support building value proposition (EBM / VBM) to patients & physicians - in collaboration with marketing, enterprise) sales functions, and professional affairs - including the development of publication plans and medical education activities. Provides oversight of medical information in promotional materials
Support the review and approval of post-market clinical research initiatives, including physician initiated clinical studies
Provides medical input for promotional and commercial activities as requested. Reviews and approves promotional materials
Medical-Scientific communications:
Supports the development of strategy and procedures related to Medical Inquiry activities
Leads Medical Inquiries related activities related to the assigned product portfolio
Drives the generation and dissemination of medical and clinical information to internal and external clients, including requests related to medical issues, practice trends, literature, etc. as appropriate
Provide evidence landscape and gap analysis via comprehensive literature reviews
Support internal cross-functional publication planning strategies
Upon request present data on Integra products to healthcare professionals
In collaboration with Medical Writing: create literature summaries, clinical quick guides and/or white papers in support of field sales
KOL interactions & engagements:
Drive alignment with Professional Affairs, Product Development, Marketing and Clinical Operations on Medical Affairs interactions with KOLs
Develop and maintain a network of leading KOLs and engage in consulting agreements with surgeons for input into medical affairs activities
Support KOL development and KOL relations programs, in collaboration with divisional stakeholders
Organize and conduct advisory boards and clinical study steering committees as required
Communicate relevant information from KOLs to internal cross-functional stakeholders
Technical knowledge:
Stay abreast of medical and scientific developments within the assigned therapeutic area by reviewing current literature, monitoring competitor activities, attending scientific conferences and networking with experts
Support internal (e.g. clinical sales specialists) and external (CME courses, labs ...) training programs
Represents the company in scientific organizations and industry associations, and regulatory group meetings regarding medical expertise
Qualifications
Education, type and number of years' experience
Five (5) years industry experience (pharma or medical devices) required, with a minimum of two (2) years in a medical affairs function
MD or DO with background in Medical Affairs management preferred
DPM, 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
Competencies
Proven understanding of the medical device or pharmaceutical arena and healthcare system requirements
Strong interpersonal, verbal and written communication skills. Ability to form strong and constructive internal as well as external professional relationships
Excellent organizational and management skills
Position requires composition ability, data analysis skills, scientific writing and presentation skills
Relevant experience in applied science, with leadership skills and ability to merge science with business goals
Thorough knowledge of FDA regulations and OIG guidance on the medical affairs functions within pharmaceutical and medical device industry
Experience with design and development of scientific research protocols, clinical investigational plans, and regulatory strategies
Effectively interacts with and collaborates at all levels in the organization, including effective interface at the senior management level
Project management experience is a plus



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