Medical Information Scientist / Medical Writer

Job Title

Medical Information Scientist / Medical Writer

Position Overview

Serve as the primary author for medical information letters, dossiers, and other documents/presentations as needed. Disseminate relevant scientific and medical information that is consistent, current, accurate, and fair-balanced in manner, capturing cases including adverse events and product complaints when presented, while maintaining corporate compliance.

Key Accountabilities / Responsibilities

• Researches, writes and edits Global Medical Information documents, including but not limited to medical information letters, AMCP dossiers for branded products, abstracts/manuscripts, slides for Medical Affairs use.
• Stay abreast of emerging scientific literature and clinical trial data, translate the data in applicable knowledge and develop scientific materials for key internal and external audiences (healthcare providers and various internal teams such as Medical Science Liaison slide development).
• Prepare/update scientifically balanced responses to unsolicited request for both labeled and off-label indications. Establish and maintain a standard answers database by obtaining internal review and approval. Maintain and distribute as appropriate and necessary.
• Document inquiry data in the Medical Information database in accordance with SOPs.
• Participate in congress strategy, including staffing of scientific booths, and collecting and reporting data and competitive intelligence
• Perform technical reviews of scientific materials for clinical and scientific accuracy for Medical Affairs, promotional materials, sales training materials, and external use materials (e.g. advisory board content and non-promotional reprints); provision of medical/scientific input, ensuring data accuracy, and consistency and compliance with product package inserts, established guidelines, institutional laws, regulations and practices.)
• Assist in the development and maintenance of product dossiers.
• Report adverse events and product complaints in a timely manner to Drug Safety and/or Product Surveillance according to SOP and compliance
• Evaluate existing templates used in writing Medical Information documents.
• Support product launches.
• Perform other duties as assigned

Minimum Education and Experience Required

• PharmD or Bachelor’s degree in pharmacy with an active/previously held pharmacy license
• One year of medical writing experience required for PharmD candidates; 2-3 years’ medical writing experience required for Bachelor of Pharmacy candidates
• Experience managing multiple projects

Education and Experience Preferred

• PharmD degree
• Residency or Fellowship in Medical Information
• Prior experience in medical writing for a biotechnology or pharmaceutical company
• Experience with medical slide development
• Experience with review of promotional materials
• Additional qualification in medical writing (e.g. American Medical Writers Association)

Knowledge, Skills, and Abilities

• Experience with literature searches and full-text document retrieval
• Excellent organizational skills
• Superb communication skills, including speaking and writing
• Self-motivated and willing to learn new skills
• Demonstrated ability to work cross-functionally
• Awareness of regulations and guidelines related to Medical Information and Medical Affairs
• Must be coachable and trainable, with an eagerness to learn
• Self-motivated
• Demonstrates initiative
• Proficient in Microsoft Word, Power Point, and Excel and have database experience.
• Experience in abstracting database (Embase and PubMed)
• IRMS – Information Request Management System experience as user and administrator preferred

United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer – EOE Minorities / Females / Protected Veterans / Individuals with Disabilities