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The job details are as follows:Manage and oversee day-to-day operational and scientific activities within medical affairs and ensure assigned Investigator Sponsored Studies (ISS) and data query programs are managed appropriately. Represent medical affairs interests and needs in multi-disciplinary teams (e.g. project teams, clinical study team meetings). Additionally, conduct and oversee small strategic studies by medical affairs.
- Oversee the ISS program in partnership with other Medical Affairs staff and provide scientific and operational support to enhance the ISS review, approval, documentation, and tracking processes
- Communicate with investigators in the ISS program and foster timely execution of newly approved and ongoing studies; lead quarterly data reviews of new data generated from ISS program
- Design, execute, and manage small strategic studies by medical affairs
- Provide operational oversight and manage external vendors/CRO for small strategic studies and non-interventional, minimal risk studies conducted by Medical Affairs; provide input for clinical operations/product development operations, as needed
- Prepare and present detailed tactics for phase IV data generation
- Collaborate with cross-functional teams to support products throughout their lifecycle (launch planning, medicine development plans, project team meetings, etc.)
- Generate material for Medical Affairs field teams and Advisory Board
- Stay abreast of developments and gather information and insight on Medical Affairs activities to leverage critical data and synthesize information for key stakeholders
- Perform back up medical technical reviews of promotional materials, sales training materials, and other material for external use (e.g. advisory board content and non-promotional reprints) by providing medical/scientific input, validation of data, and consistency and compliance with product package inserts, established guidelines, institutional laws, regulations and practices
- Collaborate with external HCPs, KOLs, and CROs to author scientific publications that further UT's medical strategy
Minimum Requirements
- Doctor of Philosophy (PhD), Doctor of Pharmacy (PharmD) or MD
- 5+ years of pharmaceutical/biotech company experience in Medical Affairs or a post-doc fellowship in Medical Affairs; Alternative pharma experience may be taken into consideration
- Excellent written and oral communication skills
- Excellent team building
- Ability to initiate and lead projects
- Record of accomplishment and increasing responsibility in scientific, clinical and/or pharmaceutical industry setting
- Solid working knowledge of word processing, spreadsheet, email and presentation software (MS Office suite)
- Ability to travel up to 35%
Job Location & Travel
This position will be located in the RTP, NC office of United Therapeutics. Currently this job is a hybrid role requiring at least three days per week in the office. In office requirements could increase based on business needs. This position will require candidates to have the ability to travel up to 35%.
In addition, this role is eligible for our short-term and long-term incentive programs. We offer a comprehensive benefits suite, including medical, dental, & vision healthcare; savings plans (401 (k) and ESPP); employee wellness resources; paid time off & paid parental leave; disability benefits; and more. For additional information on our benefits, please visit United Therapeutics Jobs | Benefits & Amenities.
