Fulfills the executive role responsible for leading and directing the overall medical affairs function for the company. Oversees and implements the strategies for addressing the medical affairs requirements necessary for the promotion and sales of the company's approved products as well as for all product development programs. The Vice President, Medical Affairs will lead efforts to communicate with physicians and other health care professionals about NovoTIF lOOA and other investigational NovoITF products. This includes responsibility for the design, creation and production of training, publications and posters, phase 4 clinical studies, adverse events, advisory boards and C:ME/CNE. Working with all relevant internal and external groups (consultants, companies) the candidate will assure accurate information is communicated and all programs are in compliance with legal and regulatory requirements and guidelines.
Responsibilities: Participates as an active member of the senior management team to ensure the strategy and vision of medical affairs is in constant support of the strategic development vision of the company.
Build, create and maintains Medical Affairs Department, with responsibility for (but not limited to) the following areas:
o NovoTTF Certification process
o Investigator Sponsored Trial Program
o Grants and Sponsorships
o Medical Communications and Information
o Clinical Science Liaison Program
o Publication Planning
Participates in organizing and conducting advisory boards, speaker training and Phase 4 research. Reviews literature, attends scientific meetings, and interacts with key opinion leaders. Management of adverse events directly with physicians as needed.
Manages and coordinates activities in producing publications and posters on clinical
trials. Participates in the review of requests for educational and training grants, CME programs
and speakers.
Operates as the primary point of technical contact for health care professionals seeking information and training about company products. Includes answering both on label and unsolicited off-label requests for product information.
Coordinates reviews and reports on technical, scientific and medical information relevant to corporate products.
Functions
Maintains close working relationship with Executive Operating Committee, Marketing and Sales Slaff, Clinical Development, and Investor Relations (as needed).
Qualifications: Professional License/Specialized Training
10 years experience working in a combination of medical affairs and clinical development function required
Strong team orientation and collaboration Ability to work independently
Organized and effective time management skills
Strong interpersonal and communication skills
Ability to manage deadlines
Good understanding of Medical Affairs and comprehensive understanding of the compliance issues concerning Medical Affairs functions
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