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Drug Information Specialist
* Design, structure, and manage de novo comprehensive product-related standard response letter and standard verbal response Q&A documents; create ad hoc letters for marketed and/or investigational products or disease state.
* Liaise with key stakeholders, including medical development, medical disclosure, medical research, clinical affairs, regulatory affairs, and global safety to obtain information and to ensure data accuracy.
* Evaluate published medical literature; provide critical review and editing on the response documents created in-house; attend scientific conferences to strengthen knowledge of company products, technologies, current trends in relevant therapeutic areas.
* Manage selected projects independently; create medical backgrounders on company's products; provide training to Med Info team at Customer Support Center (CSC), field sales and potentially field medical teams on relevant scientific information and/or operational processes; provide current medical information, communicate timelines to support medical communications strategies and department initiatives.
* Identify issues that are relevant to departmental functions and provide appropriate input and suggestions to project team or manager. Perform other duties assigned by the manager.
* Perform all responsibilities in accordance with company Standard Operating Procedures, Good Clinical Practices, and appropriate industry and regulatory guidelines. Satisfactory execution of long-term interdepartmental projects as assigned.
* Ensure that initial information regarding adverse events or product complaints of which s/he is made aware during handling of a medical information inquiry is gathered and handled according to FDA mandates and company policies.
Doctorate degree in pharmacy or medicine; PhD in bioscience or equivalent area.
2-5 years of drug information experience. Or, other health science degree such as nursing or physician assistant with 7 years of drug information experience in a pharmaceutical setting.
Solid technical writing skills, ability to assess and interpret clinical study data, tabulate and graph data; ability to conduct medical literature searches and evaluation; ability to communicate medical information verbally or in writing; expertise in using MS Word, Excel, PowerPoint, and literature management system (e.g., Reference Manager, EndNote, or ProCite.)
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BioTech FYI Center