Amgen Medical Advisor, Inflammation – 18 Month Contract Temporary in Mississauga, ON


Branch Mississauga ON CA

Medical Advisor, Inflammation – 18 Month Contract
Mississauga, ON

Knowledge of pharmaceutical product development, product lifecycle and commercialization process with advanced understanding of other functions….

Title: Medical Advisor, Inflammation – 18 Month Contract
Location: Mississauga
Grade: 5 or 6
Reports to: Medical Director, Inflammation
• The Medical Advisor will help manage the medical affairs aspect of the Inflammation Therapeutic Area, but with added responsibilities for certain Nephrology activities as delegated by the Medical Director.
– Under guidance of Medical Director, develops study protocol concepts and data analysis plans for Local AST’s; works with Clinical Senior Manager and Statistician to finalize protocols
• Works with Clinical Manager to ensure preparation, implementation and completion of AST’s (Amgen sponsored trials )
• Supports Development Operations for local studies in assessing feasibility and site selection, as well as activities necessary to ensure recruitment targets are met.
• Oversees in-sourced/outsourced Medical programs and logistics
• Participates in Local Advisory Board Meetings, Investigator Meetings and/or Steering Committees
• Review of medical content during the Copy Review of both Commercial and Medical dockets as directed by Medical Director
• Oversees the preparation of Final Study Reports
• Liaises with Medical Communication Manager for publication purposes
• Liaises with RMLs for LAST activities
• Vendor management where appropriate
• Interacts with KOLs within the Therapeutic Area for strategic discussions and protocol development as agreed with the Medical Director
• Reviews Local ISS proposals prior to approval and works with Clinical Manager to get proposals through the CaPRG, TAPRG, Regional and Global PRC processes where appropriate
• Partners with the Senior Marketing Manager/Product Manager(s) in the development and execution of the Local product(s) lifecycle management plan
• Supports Local regulatory and ethics approvals for development protocols
• Provides Medical expertise for Health Economics and reimbursement requests
• Member of Brand Teams, Therapeutic Area Teams and Medical Affairs Teams as appropriate
• Conducts TA and/or product specific Medical training where needed
• Other activities as assigned by the Medical Director
Basic Qualifications
– Medical education or deep scientific expertise and experience in relevant therapeutic area. Doctorate level degree with speciality training in the therapeutic area preferred
• Knowledge of pharmaceutical product development, product lifecycle and commercialization process with advanced understanding of other functions
• Experience in clinical trial protocol development preferred or a working knowledge thereof
• Finance and budgeting experience preferred
• Experience of interaction with Opinion Leaders on a regional and national basis
• Successful track record of managing multiple projects and competing priorities
• Solid skills in critically appraising scientific literature and conducting comprehensive searches
• Sound working knowledge of ethical, legal and regulatory guidelines and requirements applicable to scientific affairs activities
• Experience in both scientific and business presentations and communications
• Proficient in Outlook, PowerPoint, Excel, and Word software

or proceed with Standard Application Form.

Employment Type: Temporary
Location: Mississauga, ON, CA
Posted on: 2015-05-24
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