Integra LifeSciences

  • Manager, Medical Affairs, China

    Vacancy ID
    2018-26779
    Location
    CN-Shanghai-
    Position Type
    Regular Full-Time
    Category
    Clinical 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.

     

    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 4,500 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART."

    Responsibilities

    • Product strategy & product development support:
      • Support the translation of VOC / unmet needs for the Chinese market into medically relevant product design specifications
      • Support defining strategy and design of company sponsored clinical studies in China
      • Support oversight and stakeholder (e.g. investigator, CRO, etc.) interactions for company sponsored clinical studies in China
    • 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 (including those associated with clinical studies), post-market surveillance reports, and support of Health Hazard Evaluations for China
      • 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.
      • Support the review and approval of post-market clinical research initiatives, including physician initiated clinical studies in China
      • Provides medical input for promotional and commercial activities as requested. Reviews and approves Chinese-specific 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 and as pertains to the Chinese market
      • Provide evidence landscape and gap analysis via comprehensive literature reviews using Chinese databases
      • Upon request, present data on Integra products to healthcare professionals and CFDA
      • In collaboration with Medical Writing: create literature summaries, clinical quick guides and/or white papers in support of field sales for Chinese-specific audience
      • In collaboration with Medical Writing: Assist in compilation of Clinical Evaluation Reports for CFDA, including conducting literature review in Chinese-specific databases and comprehension of peer-reviewed publications
      • In collaboration with Medical Writing and Clinical Operations: Assist in compilations of clinical study documents such as research protocols and Clinical Study Reports (CSR).
    • KOL interactions & engagements:
      • Develop and maintain a network of leading KOLs and engage in consulting agreements with surgeons for input into medical affairs activities based in China
      • Support China specific KOL development and KOL relations programs, in collaboration with divisional stakeholders
      • Support the development of China specific clinical research investigators, including both KOLs and experienced clinical research centers that are not designated as KOLs
      • Organize and conduct advisory boards and clinical study steering committees as required
      • Communicate relevant information from Chinese 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, clinical studies, etc.) and external (CME courses, labs ...) training programs in China
      • Represents the company in scientific organizations and industry associations, and CFDA group meetings regarding medical expertise
      • Have detailed knowledge of CFDA registration requirements

    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, including medical writing experience
    • MD or DO with background in Medical Affairs management; Clinician with relevant degree 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
    • Must be fluent in Mandarin and English, both written and spoken
    • 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 CFDA regulations and OIG guidance on the medical affairs functions within pharmaceutical and medical device industry
    • Experience with conducting literature search and analysis of scientific publications
    • Experience with submitting Clinical Evaluation Reports to CFDA
    • 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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