Medical Information Specialist
Edison-New Brunswick Metro Area, NJ
Work with team of medical information professionals to capture unsolicited medical inquiries from health care professionals, consumers, and corporate business partners. Research and respond to requests for scientific/medical information using various search and retrieval techniques and medical literature database (product label, published and unpublished studies) to develop a medical/scientific response that is accurate, fair balanced, complete and delivered in a timely manner. Develop, disseminate, and maintain up-to-date verbal and written responses such as standard response letters (SRLs) and short approved responses (SARs) to include clinical data, package insert information, and published information. Assist in staffing of the medical information booth according to the company policies and procedures. Assist in on-boarding and training of new hires. Prepare and deliver assigned department and company training and presentations. Represent department and provide compliance support for medical information activities in external venues.
Essential Job Functions:
Respond to a variety of medical information inquiries from various sources with nominal supervision. Have frequent and direct communication with a diverse audience to relay technical/medical information that is accurate, balanced and meets compliance guidelines. Recognize and forward adverse drug events and/or product complaints in timely fashion to Pharmacovigilance and Quality departments, and document accordingly. Ensure response time to Quality assurance requests is done within one business day. Assist in staffing of the medical information booth according to the company policies and procedures.
In collaboration with medical scientific colleagues, analyze and determine appropriate scope of information response to be disseminated for non-standard inquiries. Peer review of SRLs, creation of SRLs if information is readily available and/or update existing SRLs when new or additional information is available.
Update and maintain knowledge and awareness of company s products, clinical research and current regulations through reading, attending seminars, meetings or formal classes. Represent department and provide compliance support for medical information activities.
Facilitate onboarding and training of department new hires. Assist with providing foundation training to field sales teams on current medical information request and dissemination policy.
Required Knowledge and Skills:
Knowledge of Essential Skills and Abilities
Analyzing problems, identifying alternative solutions, projecting consequences of proposed actions and implementing recommendations that support department goals and objectives.
Familiarity with pharmaceutical principles, practices and their application, comprehension of medical terminology and treatment modalities and knowledge of pharmacology principles, theory and their application.
Researching, analyzing and evaluating medical information materials using critical thinking skills and interpreting and applying medical information, instructions, policies and procedures and guidelines pertaining to medical communications and release of medical communications.
Attention to detail and excellent analytical aptitude and clear, concise communication skills both verbally and in writing
Knowledge and experience in use of computer systems and database and software applications, including Microsoft Office, Power Point, and Excel preferred.
Education and Experience
Minimum of B.S. degree with an emphasis in Science, Health Care or related fields from an accredited college or university and/or 1-2 years of pharmaceutical or related experience required. Experience can be appropriate internships or residencies. Advanced degree (PharmD, PhD) with at least three years pharmaceutical or related experience would be preferred. Working knowledge of current Food and Drug Administration (FDA), and/or other US regulatory requirements and guidelines and knowledge of therapeutic areas and research interests desired.