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Job #02537

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 Director Clinical Affairs New Jersey Salary Highly competitive package, commensurate with experience Responsibilities 1) Manage the activities and performance of the Clinical Department and Clinical staff with strategic and tactical talent 2) Generate global study protocols, which support prospective, retrospective and post market applications in consultation with clinicians and regulatory agencies 3) Act as a primary contact, providing support to clinicians and patients for worldwide investigational products and product licensing 4) Ensure data collection and study protocols comply with regulatory requirements for clinical studies conducted by the company 5) Provide statistical clinical outcomes and reports, which support worldwide regulatory submissions 6) Support reimbursement activities for company’s products 7) Provide and assist in the assurance of regulatory compliance in the distribution and use of study and/or regulated products Requirements 1) Master’s or other advanced degree in Life Sciences, Nursing, Medical technology, Biomedical Engineering or a related discipline 2) 8 years or more of clinical supervision in medical device, biologics or pharmaceutical industries experience 3) Experience in designing, completing and obtaining 5 or more clinical studies, which supported a product through FDA and multiple country registrations 4) Experience in the support and implementation of reimbursement strategies 5) Experience in biologics and/or combination product strategies 6) Excellent problem-solving and decision-making skills 7) Excellent written and oral communication skills 8) Strong knowledge of human anatomy and scientific methods 9) Strong knowledge of human anatomy and scientific methods 10) Bilingual – English with Asian Pacific, Spanish a plus 11) Self-motivated with a proactive attitude and the ability to work independently 12) Excellent organizational skills 13) Willingness to travel – up to 25%