Medical Information Specialist

Job Summary

The Medical Information Specialist within Medical Affairs is responsible for responding to unsolicited inquiries related to Dendreon products, including PROVENGE®, by providing accurate, evidence-based medical information to healthcare professionals, patients, consumers, and payors. Reporting to the Director of Pharmacovigilance, the role supports medical response development, cross-functional collaboration, and pharmacovigilance activities to ensure the safe and effective use of PROVENGE®.

Responsibilities

• Serves as an essential link between Dendreon Medical Affairs and healthcare professionals (HCPs) and non-HCPs (including patients and payors); assisting with the appropriate dissemination of scientific information, while continuously monitoring enquiry trends and metrics and proactively identifying unmet content needs and product trends to the wider Dendreon audience.
• Works collaboratively with cross-functional teams (i.e. Apheresis Operations, R&MS/Process Engineering, Microbiology, Quality, Pharmacovigilance, Patient Operations and Nursing Services) on all lot failure notifications, reviews and follow-up communications with HCPs.
• Key activities include, but are not limited to:
• Initiation of medical lot failure notification call to practices
• Peer to peer conversations on type of product failure
• Post-lot failure follow-up communications with the purpose of increasing success with subsequent individual patient infusions
• Processing HCP orders for infusion parameters outside of label guidelines, monitoring manufacturing failures for sterility issues
• Following-up on sterility failures per product PI, managing and attending weekly rounds meetings
• Serving as an FDA inspection subject matter expert (SME) for Medical Information and point-person for Medical Affairs, and always ensuring audit readiness for Medical Information.
• Facilitating Medical Information services and support for Dendreon Medical Affairs at scientific conferences and meetings including, but not limited: Pre-conference preparation, scientific conference information topics, Attend scientific conferences, Answer questions at medical booths (in person or virtually).
• Serves as an FDA inspection subject matter expert (SME) for Medical Information and point-person for Medical Affairs, and always ensures audit readiness for Medical Information.

Qualifications

• Advanced clinical and scientific training required (Master’s, PharmD, PhD, RN, MD).
• 1-3 years of work experience within the pharmaceutical industry or related health care business field.
• Scientific/clinical experience in the therapeutic area [oncology/prostate cancer/immunology] highly desirable.
• Demonstrated ability to work in a small team and matrixed environment.
• Ability to work collaboratively and coordinate the efforts of in-house and field team members to resolve customer enquiries and produce high-quality responses.
• Demonstrated ability to produce clear, concise, and effective written and oral communications describing scientific and clinical data.
• Well-organized with ability to prioritize tasks, work simultaneously on multiple projects and produce high-quality work documents according to prescribed timelines.
• Able to work under limited direction.
• Proactively and independently approaches work with good problem-solving skills and ability to critically evaluate and synthesis data from a broad range of disciplines.
• Demonstrated ability to pay attention to details, good project management and critical-thinking skills.
• Able to work in a fast-paced, cohesive, collaborative work environment.
• Able to gain cooperation of others.
• Proficient in MS Office applications.

Preferred Requirements

• Previous work experience in Medical Information or Medical Communications a plus.
• Previous work experience in Pharmacovigilance a plus.
• Knowledge of applicable regulatory and legal requirements for the provision of medical information and PV reporting requirements in the pharmaceutical environment a plus.
• Previous IRMS software management experience a plus.
• Experience with medical content writing and/or presenting of scientific, health economic, and clinical data.
• Effective project planning, and an aptitude in presenting scientific and clinical data.