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Company
Orion Healthcare Recruiters/ Consultants
Contact Name:
Kevin Coughlin
Phone:
(905) 331-6552 1-888-347-8272
fax (905) 331-6537 Cell 416-561-3606
Email:
orionhc@bellnet.ca
TITLE: Medical Advisor, Oncology
LOCATION: Mississauga - Biotechnology - based
ROLE:
-To assist Medical Director in the development and implementation of the TA Medical Strategy and Medical activities for the product(s) in accordance to internal and external regulations
-To provide state-of-the-art medical insight into specific molecules to Local and global teams and serve as the focal point of contact
-Management of internal and external relationships within area of responsibility
-Product(s) lifecycle management
-Under guidance of Medical Director, develops study protocol concepts and data analysis plans for Local Sponsored Trials (ASTs); works with Clinical Senior Manager and Statistician to finalize protocols
-Visits selected KOL’s and study groups for strategic discussions and protocol development in areas assigned by Medical Director
-Works with Clinical Senior Manager to ensure preparation, implementation and completion of Local AST’s
-Reviews Local Investigator Sponsored Study (ISS) proposals prior to approval and works with Clinical Senior Manager to get proposals through company review processes
-Partners with the Senior Marketing Manager/Product Manager(s) in the development and execution of the Local product(s) lifecycle management plan
-Supports Development Operations for global/local studies in assessing feasibility and site selection, as well as activities necessary to ensure recruitment targets are met.
-Supports Local regulatory and ethics approvals for development protocols
-Participates in the development of North American regional medical strategies and tactics in close collaboration with the Medical Director and NAML in area of responsibility
-Oversees in-sourced/outsourced Medical programs and logistics
-Review of medical content during the Copy Review of both Commercial and Medical dockets when requested
-Ensuring consistency of Medical content and scientific messages across various tools and materials
-Participates in/conducts Local Advisory Board Meetings, Investigator Meetings and/or Expert Panels
-Provides Medical expertise for Health Economy and reimbursement requests
-Member of Brand Teams, Therapeutic Area Teams and Medical Affairs Teams as appropriate
REQUIREMENTS:
-Minimum of 2 years in pharmaceutical industry, or proven industry collaboration in academia
-Experience in affiliate Medical Department or Clinical Development an asset
-Experience with clinical study management and conduct
KNOWLEDGE:
-Medical and scientific expertise / Therapeutic area knowledge
-Knowledge of pharmaceutical product development, product lifecycle and commercialization process with advanced understanding of other functions; including, but not limited to, Clinical Operations, Commercial, Regulatory, and Medical Affairs
-Continuously expanding medical and scientific knowledge
-Working/expanding knowledge of the marketing and sales process, particularly marketing communications
-Strong clinical research knowledge (study design, study evaluation, expert panel conduct, symposium and workshop management, KOL management, HE understanding)
-Ability to work in a cross-functional team (e.g., Commercial, Clinical Development, EU teams, HE, Regulatory, Safety, etc.)
-Demonstrated leadership skills
-Role model for others in line with company Values
-Strong customer orientation; science-based;
-Network of customer contacts in therapeutic area
-Strong communication and presentation skills
-Finance and budgeting experience
-Fluency in English, both oral and written communications. Fluency in French would be an asset.
-Proficient in Outlook, PowerPoint, Excel, and Word software programs
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