Medical Information Manager

United Therapeutics CorporationRTP, NC, NC
Hybrid

About The Position

United Therapeutics (Nasdaq: UTHR) is a publicly-traded biotech or pharmaceutical company operating as a public benefit corporation, focused on developing novel pharmaceutical therapies and technologies for rare, deadly diseases and expanding the availability of transplantable organs. Founded in 1996, the company has developed six FDA-approved therapies for conditions like pulmonary arterial hypertension (PAH), pulmonary hypertension associated with interstitial lung disease (PH-ILD), and neuroblastoma. Their near-term pipeline targets PAH and pulmonary fibrosis (PF). Recognizing the organ transplant shortage, United Therapeutics is also working on creating manufactured organs to eliminate transplant waiting lists. The company is described as passionate, inspiring, bold, and unconventional, with a mission to provide a brighter future for patients. The primary objectives of the Medical Information Manager is to develop and maintain medical affairs materials that support all stages of a brand's life cycle, including standard response documents, frequently asked questions, and educational resources such as slide decks and leave behinds. This role is responsible for communicating in writing or verbally, relevant scientific medical information that is consistent, current, accurate, and fair-balanced in a timely manner to healthcare providers that use United Therapeutics products. The Medical Information Manager will be adept at recognizing and capturing adverse events and product complaints and escalating to Global Patient Safety. This role will be an expert in Veeva MedInquiry and will assure consistency in documentation of cases to produce meaningful metrics.

Requirements

  • Doctor of Pharmacy (PharmD) with an active pharmacy license
  • 2+ years of pharmaceutical industry medical information experience or hospital experience
  • Experience in abstracting database (Embase and PubMed) for literature searches and full-text document retrieval
  • Ability to manage multiple projects simultaneously and according to agreed upon time lines and budgets
  • Awareness of regulations and guidelines related to Medical Information and Medical Affairs
  • Excellent organizational skills
  • Superb verbal and written communication skills
  • Self-motivated with a willingness to learn new skills
  • Demonstrated ability to work cross-functionally and be an exceptional collaborator
  • Proficient in Microsoft Word, Power Point, and Excel with database experience

Nice To Haves

  • 1+ years of medical writing experience
  • 1+ years of a Medical Information Fellowship
  • Experience and knowledge with developing field medical slides for external use
  • Participation in accredited medical writing associations (e.g. American Medical Writers Association)
  • Experience with Information Request Management Systems (IRMS) or Veeva MI as an end user and/or administrator, or demonstrated technical aptitude with the ability to quickly learn new systems and processes
  • Clinical experience in pulmonary hypertension

Responsibilities

  • Collaborate with GMI Product Leads to research, develop, and maintain materials supporting all stages of a brand’s life cycle, including standard response documents, frequently asked questions, AMCP dossiers, and educational resources such as slide decks and leave behinds
  • Develop and update scientifically balanced responses to unsolicited requests for both on- and off-label indications; assist in maintaining a standard response database by obtaining internal review and approval and maintaining and distributing responses, as appropriate
  • Assist in the development and maintenance of AMCP-format product dossiers
  • Act as a subject matter expert on company products and data; stay abreast of emerging scientific literature and clinical trial data, translate data into applicable knowledge, and develop educational materials for key internal and external HCP audiences
  • Develop a working knowledge of Veeva Med Inquiry to efficiently manage medical information requests and escalations supporting the Contact Center Team and ensure timely, accurate responses
  • Assist in the planning and execution of scientific congress booth strategies, including the creation of study design handouts, adverse event management materials, and pipeline overview slides; provide staffing support for Medical Information and Medical Affairs booths; collect and report data, competitive intelligence, and other insights
  • Report adverse events and product complaints to Global Patient Safety/Pharmacovigilance in a timely manner in accordance to SOPs and compliance requirements
  • Assist in maintaining the Publications Library and Clinical Trials sections of the corporate website
  • Evaluate existing templates used in the development of Medical Information documents
  • Actively contribute to medical affairs workstreams, launch meetings, insights forums, and other projects and initiatives

Benefits

  • medical / dental / vision / prescription coverage
  • employee wellness resources
  • savings plans (401k and ESPP)
  • paid time off & paid parental leave benefits
  • disability benefits
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