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Job #02541

About our client Our client is in the field of human bone and connective tissue processing for transplants and is a world leader in their field. They are also an innovator in the development, manufacturing, and marketing of biological, biometrical, and device systems for musculoskeletal surgery. The company’s present and development-stage technologies address the needs within many musculoskeletal disciplines. Position Location Manager Clinical Affairs New Jersey Salary Highly competitive package, commensurate with experience Responsibilities 1) Report to the responsible executive for Regulatory, QA and Clinical affairs 2) Manage the activities and performance of the Clinical Department and Clinical staff with strategic and tactical talent 3) Generate global study protocols, which support prospective, retrospective and post market applications in consultation with clinicians and regulatory agencies 4) Act as a primary contact, providing support to clinicians and patients for worldwide investigational products and product licensing 5) Ensure data collection and study protocols comply with regulatory requirements for clinical studies conducted by the company 6) Provide statistical clinical outcomes and reports, which support worldwide regulatory submissions 7) Support reimbursement activities for company’s products 8) Provide and assist in the assurance of regulatory compliance in the distribution and use of study and/or regulated products Requirements 1) BS degree, RN in Nursing or related Sciences, Public Health Degree, Biomedical Engineering, Masters Degree preferred 2) 4-8 years of clinical experience in the medical device, biologics or pharmaceutical industries 3) Minimum 1 year of supervisory experience 4) Designed, completed and obtained 3 or less clinical studies, which supported a product approval through FDA and an international registration 5) Experience in biologics or combination product strategies preferred 6) Excellent written and oral communication skills 7) Strong knowledge of human anatomy and scientific methods 8) General computer knowledge i.e. Excel and Microsoft Project 9) Bilingual – English with Asian Pacific, Spanish a plus 10) Self-motivated with a proactive attitude and the ability to work independently 11) Excellent organizational skills 12) Willingness to travel – up to 25%