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Job #03269

About our client Our client is the biotech division of a world leading healthcare company that has developed a reputation for successfully bringing complex products to the market in a variety of therapeutic areas. With an experienced clinical team and empowering corporate culture that is focused on the professional development of its employees, this is a great opportunity for the right candidate! Position Location Manager, Clinical Southern California Salary Highly competitive package, commensurate with experience Responsibilities 1) Provide clinical expertise within an individual therapeutic unit and clinical knowledge for the entire product line(s) related to that therapeutic unit 2) Lead strategic assessment, planning and execution of scientific communications as well as post-market research initiatives 3) Supervise/train employees within the therapeutic area 4) Provide medical/clinical expertise related to products to internal (marketing, manufacturing, QA, RA, R&D and legal) as well as external (healthcare professionals, patients, etc.) customers from the US and abroad 5) Assist in resolving product queries/complaints 6) Review/approve advertising and promotional as well as scientific and educational materials within the therapeutic area 7) Conduct strategic assessment (gap analysis) of information needs within the therapeutic area and develop fulfillment strategies (publication/research planning, educational activities, attendance at key medical meetings and advisory boards, etc.) 8) Serve as a member of the advertising/promotional review committee representing Global Medical Affairs and provide editorial input related to product line/therapeutic area 9) Develop/execute internal and external education/internal training programs with respect to medical/clinical issues within the product line/therapeutic area 10) Maintain current knowledge and understanding of regulatory and quality requirements 11) Lead the planning, development and execution of product launches (write/amend package inserts, license submissions and develop training materials) 12) Maintain/possess a current familiarity of the published medical literature relating to the product line/therapeutic area and serve as a resource regarding clinical trends and their potential impact 13) Participate in post-market research initiatives including development of safety surveillance registry protocols, study database analyses and reporting 14) Develop strategies and initiatives that will improve and streamline current processes within Global Medical Affairs to improve scientific data and communications services to internal/external customers 15) Oversee product development including clinical appropriateness reviews Requirements 1) Advanced degree (Pharm. D., Ph. D., M.D.) 2) 2+ years of experience in a pharmaceutical, medical device or biotech company preferred 3) Supervisory or clinical experience preferred 4) Familiarity with ICH guidelines/GCP 5) Strong interpersonal and communication (written and oral) skills 6) Superb presentation, teaching and IT skills 7) Ability to manage conflict situations and a proven track record of responsible actions 8) Ability to participate in a cross-functional team by approaching and influencing, initiating, accepting change and addressing complex, multi-faceted question/issues 9) Exceptional follow-through with respect to tasks and projects