Medical Information Specialist
Leverage medical, scientific and product knowledge, clinical expertise, literature evaluation and writing skills to influence the successful adoption and utilization of CSL Behring products with Key Opinion Leaders, formulary decision makers, prescribers, other healthcare professionals (HCP), caregivers and patients. Be an expert resource in educating and training stakeholders about CSL products.
The Medical Information Specialist (MIS) is the medical data and disease state expert in writing evidence-based, balanced standard response letters (SRLs) and frequently asked questions (FAQs), managed care responses and medical presentation creation and review.
Ensures the accurate and detailed medical reviews of US commercial advertising and promotional materials, contributing insights and perspectives based on medical product expertise, in compliance with US regulatory requirements.
The MIS is seen as the expert consultant on database analysis, providing insights and trends on the market from healthcare professionals (HCPs) and consumers.
The MIS team facilitates communication and collaboration with internal stakeholders to optimize customer responsiveness and enhance CSL s reputation as a scientifically innovative industry partner. Maintain our commitment to quality and compliance in supporting our products through our corporate values of customer focus, innovation, integrity, collaboration and superior performance.
Requirements:
Main Responsibilities and Accountabilities:
1. Leads efforts in researching, writing, and reviewing database of accurate, evidence-based, balanced medical information SRLs and FAQs for US and Global Medical Affairs that results in effective communication with our internal and external stakeholders. Establishes and conducts periodic review of current literature for evaluation and inclusion in responses that results in appropriate utilization of our therapies. Collaborates with various internal colleagues across levels, including senior marketing executives and global Medical Affairs and commercial partners to analyze and manage database for strategic relevance and optimization.
2. Leads efforts to evaluate and respond effectively to unsolicited medical information requests from external customers for the entire FDA approved CSL Behring product line and pipeline products, increasing appropriate use. Identifies, evaluates and triages adverse drug events and product technical complaints, documenting accordingly and notifying appropriate company stakeholders. Extensively researches and develops responses for escalated, complex off-label medical information inquiries from HCPs for all therapeutic area(s).
3. Leads medical review of US promotional resources through promotional review committee (PRC) to certify that materials are medically and scientifically accurate, clinically relevant and balanced, as well as compliant with FDA regulations. Recommendations, actions and decisions made are critical to ensure compliance with applicable regulatory standards pertinent to the promotion of pharmaceutical products. The actions of this position impact decision-making regarding company products with respect to patient safety and prescribing behavior. Participates as active member of PRC meetings and documents all reviews in ZincMaps, articulating information to a variety of audiences, and effectively negotiating with counterparts from cross-divisional functional areas, including Medical Therapeutic Area Leaders, Marketing, Legal, Regulatory, and Business Operations. Functions independently in decision-making and prepares and recommends feasible solutions. Independently resolves higher risk or complex issues having the potential for financial, legal or regulatory implications. Facilitates and leads review of medical affairs resources through medical legal review (MLR).
4. Is seen as the expert in an assigned therapeutic area(s) and disease state(s) involving clinical issues related to CSL Behring s product. Works across various functions to maintain collaborative relationships. Is highly networked and remains current to be able to interpret, analyze and convey pertinent scientific data and evaluate new information to make relevant scientific contributions in the area. Collaborates with Medical Affairs team of Medical Therapeutic Area Lead, MSL Leaders, MSLs and Medical Science Managers to drive strategic therapeutic area(s) initiatives in a manner that demonstrates scientific excellence.
5. Develops, reviews and/or delivers scientific resources including AMCP dossiers used for formulary review, product or disease state slide decks, manuscripts, sales training modules, product monographs, scientific statements, managed care presentations, and product labeling (prescribing information), and proactively shares across Medical Affairs. Supports therapeutic area for new initiatives and develops related medical information resources.
6. Facilitates, leads and attends appropriate national or regional medical conferences to learn and evaluate new scientific, product or competitive information, and to respond to inquiries from HCPs and KOLs. Represents CSLB while managing unsolicited inquiries, interacting with customers and assess impact to our business. Uses the knowledge to enhance Medical Information strategy.
7. Analyzes medical information inquiries documented in Compass and issues reports to identify competitive intelligence trends, occurrence of new issues and any patterns for database improvement and new opportunities for scientific growth (training, collaboration). Advisory to the manager or other Medical Affairs personnel, including MTALs for development of overall strategy for US Commercial Operations as it relates to direct external customer interactions (HCP, customers, etc.).
8. Initiates collaboration with Pharmacovigilance, Regulatory Affairs, Clinical Research, R& D, Product Development, as well as Customer Support, Consumer Affairs, Quality, Manufacturing and Legal departments as appropriate to integrate responses to medical and product inquiries, and to assure that key messages are consistent and accurate throughout US Commercial Operations and Global Medical Affairs.
9. Advisory of governance of Medical Affairs and Medical Information departments through development of Standard Operating Procedures, Work Instructions, processes and style guides. Conducts training on CSL Behring products, related disease states and procedures for internal and external partners, including sales training, customer support and Medical Affairs vendors
10. Responds to elevated medical inquiries as the on-call expert for CSL Behring products after-hours.
11. Conducts monthly QA review of incoming medical inquiries handled by medical affairs and after hours vendor to ensure adherence to corporate compliance.
Education
PharmD or advanced degree in Pharmacy.
Experience
Previous hospital or clinical setting experience.
At least 2 years experience in the pharmaceutical industry with some drug or medical information experience (fellowship or residency in the pharmaceutical industry will apply).
Worker Type:
Employee
Worker Sub Type:
Regular
