Integra LifeSciences

Medical Affairs Manager (Japan)

Vacancy ID
2017-22309
JP-Home Office
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, reconstructive and general surgery, and regenerative wound care.  Founded in 1989 Integra is headquartered in Plainsboro, New Jersey and has nearly 4,000 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART."

 

Integra LifeSciences has entered into an acquisition agreement of Codman Neurosurgery.   This transformational acquisition creates compelling value for our shareholders, employees and patients, and enhances our global position in neurosurgery by adding a complementary product portfolio and the world-recognized Codman brand. This expansion position is open as a result of this exciting acquisition.

Responsibilities

Product strategy & product development support:

  • Supports the development of strategy and procedures related to Medical Affairs input into product development 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 
  • Support building value proposition (EBM / VBM) to patients & physicians 
  • Support the review and approval of post-market clinical research initiatives
  • Provides medical input for promotional and commercial activities

Medical-Scientific communications:

  • Supports the development of strategy and procedures
  • 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
  • Provide evidence landscape and gap analysis via comprehensive literature reviews
  • Support internal cross-functional publication planning strategies
  • Present data on Integra products to healthcare professionals

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
  • Organize and conduct advisory boards and clinical study steering committees 
  • Work closely with 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 and any related organizations 

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
  • Good understanding of the medical device or pharmaceutical arena and healthcare system requirements
  • Strong interpersonal, verbal and written communication skills in both Japanese and English
  • Excellent organizational and management skills
  • Relevant experience in applied science, with leadership skills
  • Knowledge of FDA (or HHS) 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
  • Project management experience is a plus

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