About the Company
Our Client, a commercial leader in regenerative medicine, is currently seeking a Manager of Medical Information to join their team. This is a highly-visible role inside a phenomenal work culture, and a chance to work among the top-talent in medicine and make a difference in people's life.
The Manager, Medical Information will be responsible for appropriately triaging, processing, and handling unsolicited inquiries from internal and external stakeholders related to any company assets and/or therapy areas. Key responsibilities include:
- Development and maintenance of a repository of high quality medical information standard response documents (SRDs)
- Developing, organizing and centralizing the process of collecting and sharing scientific information and serve as the internal knowledge management expert/resource.
- Serving as the non-promotional review committee (NPRC) coordinator for facilitating the review approval of all externally-facing medical materials.
- Evaluating and identifying initial reports of adverse events and product/technical complaints and forward potential adverse events and product/technical complaints in accordance with company SOP's
- Conducting comprehensive, targeted, and thorough literature and information searches (including databases, PubMed, government websites, etc.) to assist in the development/revision of MI response documents
- Participating in the creation of, and ensure adherence to, OI departmental policies and SOPs
- Developing and maintaining a structured, up-to-date literature repository of medical/scientific literature references for internal stakeholder use
- Providing medical information booth support at key medical/scientific conferences (as required)
Share This Position:
- Successful track record in medical information and/or medical affairs with a minimum of 2 to 4 years of medical information experience
- Thorough understanding of federal regulations and guidance pertaining to medical information/communications processes and adverse event reporting
- Advanced scientific degree required equivalent to PharmD, PhD, PA, MD/DPM, RN or similar advanced degree
- Excellent organizational, interpersonal, and communications skills
- Ability to effectively manage time while balancing numerous high-priority projects with a sense of urgency
- Must be a strong team player and be willing to work in an environment where individual initiative and accountability to the team are required