Medical Information Manager

United Therapeutics•Rtp, NC

2d•Hybrid

About The Position

The Medical Information Manager will 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 MIM will be adept at recognizing and capturing adverse events and product complaints and escalate to Global Patient Safety. They will be an expert in Veeva MedInquiry electronic system and assure consistency in documentation of cases to produce meaningful metrics. 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, educational resources such as slide decks and leave behinds. Develop and update scientifically balanced responses to unsolicited request for both on- and off-label indications. Assist in maintaining a standard response database by obtaining internal review and approval; Maintain and distribute as appropriate and necessary Assist in the development and maintenance of AMCP format product dossiers Act as a subject matter data on UT products and data. Stay abreast of emerging scientific literature and clinical trial data, translate the 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 to 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 reporting data and competitive intelligence and other insights Report adverse events and product complaints in a timely manner to Global Patient Safety/Pharmacovigilance according to SOPs and Compliance Assist in maintaining the Publications Library and Clinical Trials sections of our Corporate website Evaluate existing templates used in writing Medical Information documents Contribute actively to medical affairs workstreams, launch meetings, insights forums and other projects/initiatives

Requirements

Doctor of Pharmacy (PharmD) with an active pharmacy license
2+ years of direct industry medical information through a post-PharmD MI fellowship or 2+ years of pharmaceutical industry/medical information experience or hospital clinical 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 communication skills, including verbal and written
Self-motivated and willing to learn new skills
Demonstrated ability to work cross-functionally and be an exceptional collaborator
Proficient in Microsoft Word, Power Point, and Excel and have database experience
Ability to travel up to 10%

Nice To Haves

1+ years of medical writing experience
Experience and knowledge with developing field medical slides for external use
Participation in accredited medical writing associations a plus (e.g. American Medical Writers Association)
IRMS – Information Request Management System or Veeva MI experience as user and administrator; or be technically proficient and can quickly learn
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, educational resources such as slide decks and leave behinds.
Develop and update scientifically balanced responses to unsolicited request for both on- and off-label indications.
Assist in maintaining a standard response database by obtaining internal review and approval; Maintain and distribute as appropriate and necessary.
Assist in the development and maintenance of AMCP format product dossiers.
Act as a subject matter data on UT products and data.
Stay abreast of emerging scientific literature and clinical trial data, translate the 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 to 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 reporting data and competitive intelligence and other insights.
Report adverse events and product complaints in a timely manner to Global Patient Safety/Pharmacovigilance according to SOPs and Compliance.
Assist in maintaining the Publications Library and Clinical Trials sections of our Corporate website.
Evaluate existing templates used in writing Medical Information documents.
Contribute actively to medical affairs workstreams, launch meetings, insights forums and other projects/initiatives.