Medical Affairs Operations

Duties:
The Contractor, Medical Education & Grants is responsible for driving processes and maintaining systems critical to the compliant and efficient execution of US and Global Medical Education plans that support impactful independent medical education programs for HCPs.

Drive medical education grant strategy including areas of interest, gap analysis, funding, etc in collaboration with cross-functional partners
Oversight and management of incoming medical education grant requests (review, summarize, and make recommendations) for the companies therapeutic areas of interest while adhering to corporate policies and regulatory guidelines
Oversight of compliant grants management system, grant review committee meeting facilitation, contracting, budget planning, audit readiness, development of project management tools, reports, and timelines for medical education programs.

Develop medical education strategy and deliver related tactics including live and enduring independent medical education programs (i.e. CME programs)
Summarize/create reports for grants tracking, status reports, metrics, and comprehensive outcomes analyses for Medical Affairs internal stakeholders
Work with the Finance department to develop and track budgets; facilitate contracting; participate in annual budget and forecasts
Establish, maintain and lead training on data management systems that effectively supports the review/approval process, archiving and maintenance of all grants programs
Identify and communicate any key findings on educational gaps, updates and/or enhancements needed that support medical education and grants strategy
Support standardization across global geographies and country regulations to ensure consistent, compliant and best in class educational/grants resources
Communicate with medical education providers to facilitate timely, consistent outcomes reporting, metrics, reconciliation, follow-up, program close outs, etc
Ensure the Medical Education Grants process is consistent with the companies policies & SOPs and compliant with current relevant guidelines including, but not limited to, FDA and regulatory guidelines (i.e., PhRMA guidelines, OIG, AMA, ACCME, CME Open Payments reporting, etc.)
Observe supported medical education programs online and on-site as needed
Drive continual process improvement to enhance efficiency and effectiveness
Manage other grant types (i.e. charitable donations, medical sponsorships, research awards, external research such as investigator initiated research, research grants) as needed

Skills:
A minimum of 7-10 years of relevant experience in the pharmaceutical/biotech industry, of which at leat 5 years in Medical Education Grants management required.
Expert knowledge of relevant guidelines including, but not limited to medical and regulatory affairs, drug development, FDA and regulatory guidelines (i.e., PhRMA guidelines, OIG, AMA, ACCME, Sunshine Act, etc.)
Strategic thinking with ability to connect multiple components
Leadership presence and ability to present and engage across the organization
Strong communication skills
Ability to build effective relationships with internal partners
Enables creative problem solving, encourages unique solutions, and effectively solves challenges problems
Flexible approach to changing priorities and business needs
Forward looking with continuous process improvement mentality
Ability to create, track and plan timelines and budgets
Experience in management of grants management system
Ability to manage external vendors and provide clear, concise direction

Education:
Bachelor’s degree required, advanced degree preferred (PharmD, PhD, MD, NP-C )

Pay ranges between $105-116.48/hr based on experience