Integra LifeSciences

Manager, Medical Affairs

Vacancy ID
2017-24391
US-NJ-Plainsboro
Position Type
Regular Full-Time
Category
Medical Affairs

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, spine surgery, and reconstructive and general surgery.

 

Integra's orthopedic products include devices and implants for spine, foot and ankle, hand and wrist, shoulder and elbow, tendon and peripheral nerve protection and repair, tissue reconstruction and wound 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. 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 3,500 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART."

Responsibilities

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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