As part of Medical Affairs team and reporting to the Executive Director, Medical Affairs, this individual would work with Medical, Commercial and Regulatory team members in planning, implementing and executing projects related to the development and management of a commercially-ready risk management program, in accordance with company SOPs, FDA and ICH guidelines and regulations. Additionally, this role will provide support for Medical Review Committee (“MRC”) activities, including coordination of the review of medical and scientific materials intended for use in non-promotional settings with healthcare providers, presentations to Managed Care, Market Access Pharmacy and Therapeutics (P&T) Committees, and Medical Affairs training.
This individual will play a pivotal role in managing timelines and deliverables for key risk management and MRC milestones for the company. He/she will need to apply project management related support to teams and team leaders to meet overall corporate objectives in building a compliant REMS program and MRC process. This individual must work collaboratively with all levels of internal and field staff in addition to maintaining professional demeanor with outside contacts.