Develop responses to medical information inquiries
Ensure written materials are accurate, timely, and scientifically balanced
Manage materials through the Medical-Legal-Regulatory approval process
Screens inquiries for safety and product issues per company policies
Assist in the management of Medical Information Booths at medical meetings including but not limited logistics, staffing, and medical information training
Supports maintaining the Medical Information database with periodic reviews and updates and appropriate documentation of inquiries
Assist in the management of vendors contracted by the Medical Information Services
Conducts scientific searches and reviews clinical data to develop content for standard response letters
Additional responsibilities may include involvement in Pharmacovigillance and/or Medical Educational activities as determined by Medical Affairs leadership.
Significant experience relevant to Medical Information throughout product life cycle.
Advanced scientific degree or equivalent preferred (PhD, MD, PharmD, RN) in clinically relevant area (Neurology).
At least 2-3 years of experience in Medical Information in the pharmaceutical industry.
Working knowledge of regulatory guidances and general medical information practices.
Excellent written, oral communication and presentation skills to ensure that scientific information is communicated accurately.
Excellent technical (scientific) and writing skills.
Excellent ability to search and evaluate medical literature.
Ability to work in fast-pace and ever-changing environment a must, as well as the proven track record of working effectively in diverse teams involving multi-functional disciplines
Strong analytical skills necessary to interpret clinical data.
Ability to maintain high level of productivity with minimal supervision.
Medical Affairs experience in pre-launch and launch activities of drug product desirable.
Expertise in MS Office programs (Word, PowerPoint, Excel, etc).
IMPAX Laboratories - 19 months ago