Job Summary (Primary function):
Essential Functions of the Job (Key responsibilities):
Manage day-to-day call center operations, including provision of outstanding customer service through timely and compliant handling of medical inquiries, AEs, and PCs consistent with Company and regulatory guidelines
Provide oversight to third party call center agencies, including communicating pertinent business and process updates, ensuring adequate staffing, provision of training, and monitoring of AE, PC, and medical inquiry handling
Has supervisory responsibilities for MICC team members
Serves as member of Medical Affairs Leadership Team (MALT), and contributes actionable input towards department strategy, hiring, budget, process, and policy decisions
Generate and disseminate metrics and analytics related to MICC operations
Oversee the day-to-day utilization of MICC systems, and interface with IT and other functions to ensure appropriate updates and maintenance
Develop annual MICC goals and objectives and deploy to team members
Assist in developing written scientific materials, including custom responses, standard response documents, and Question & Answer documents (Q&As)
Participate in cross-functional meetings to share customer insights and provide timely updates on inquiry trends and related responses
Collaborate with global and regional Medical Affairs colleagues to develop and communicate operational standards, best practices, and relevant scientific resources
Develop and maintain MICC-related standard operation procedures, work instructions, and other pertinent reference documents
Ensure MICC operation operates in state of audit readiness and serve as point-of-contact for audits
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 significant experience working in a Medical Information/Medical Affairs capacity for a pharmaceutical or medical device company, is required.
Experience handling medical inquiries, AEs, and PCs, including processing in a Medical Information system, is required.
Knowledge of FDA regulations regarding the dissemination of Medical Information, drug promotion, and adverse event and product quality complaint reporting, is required.
Experience creating scientific content, including MIRLs, 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 oncology, hematology, dermatology, or immunology is strongly preferred.
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.
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