at Incyte Corporation in Wilmington, Delaware, United States
Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
Job Summary (Primary function):
The Senior Specialist/Manager, Medical Information is responsible for responding to inbound medical inquiries from healthcare professionals (HCPs), patients, and caregivers. The position will also be responsible for the intake and handling of adverse events (AEs) and product quality complaints (PQCs) related to marketed products. In addition, the individual will be responsible for the development of scientific materials used to address customer inquiries.
Essential Functions of the Job (Key responsibilities):
Provide timely, accurate, thorough, and balanced responses to unsolicited customer requests for medical information consistent with Company and regulatory guidelines
Identify, capture, and process AEs and PQCs in accordance with Company guidance documents
Assist in developing written scientific materials, including medical information response letters (MIRLs), custom responses, and Question & Answer documents (Q&As)
Manage day-to-day call center operations, including maintenance of standard operating procedures (SOPs), and oversight of third-party call center vendor
Generate and exchange routine customer insights/reports with internal partners
Demonstrate ongoing scientific and business expertise relevant to therapeutic areas, including products, disease state management, emerging therapies, and the competitive landscape
Provide medical information support at medical meetings
Comply with all guidelines, policies, legal, regulatory, and compliance requirements
Qualifications (Minimal acceptable level of education, work experience, and competency):
Healthcare Professional (PharmD, MD, RPh, PhD in related field) with 1-3 year experience working in a Medical Information/Medical Affairs capacity for a pharmaceutical or medical device company, or equivalent clinical experience, is required.
Experience creating scientific content, including MIRLs, is required.
Knowledge of FDA regulations regarding the dissemination of Medical Information, drug promotion, and adverse event and product quality complaint reporting, is required.
Ability to query scientific literature (via PubMed, Embase, Scopus, etc.) and identify and summarize pertinent findings is required.
Excellent oral and written communication skills are required.
Excellent project management skills, including the ability to plan, prioritize, and execute multiple projects are required.
Experience in using IRMS systems is desired.
Experience in oncology, hematology, dermatology, or immunology is strongly preferred.
Approximately 10% travel commitments.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
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We appreciate, celebrate, and thrive on one another’s differences and strengths and are proud to be an Equal Opportunity Employer. By valuing diversity of backgrounds and perspectives and prohibiting all forms of harassment, we are able to promote a collaborative and innovative work environment in which everybody can contribute to their fullest potential.