Medical Information Specialist
Influence and lead the successful adoption and utilization of CSL Behring products in all markets with Key Opinion Leaders, formulary decision makers, prescribers, other healthcare professionals (HCPs), patients and caregivers through medical and clinical expertise, scientific knowledge, literature evaluation and medical writing skills. Create and review evidence-based standard response documents, slide presentations and managed care responses used in global CSL Behring markets to share critical product information with healthcare professionals. Drive the detailed, accurate review of US commercial advertising and promotional materials, providing insights and perspectives based on medical product expertise in compliance with US regulations. Lead training initiatives within Medical Affairs and other internal organizations including Sales, Sales Training, Marketing and Corporate Accounts. Provide guidance on labeling documents for current and pipeline CSL Behring products. Actively engage at medical congresses and provide competitive updates back to CSL personnel. Manage vendor relationships for after-hours coverage and other partnerships.
Create accurate, balanced and medically relevant medical information responses to answer unsolicited questions for all CSL Behring approved product line and pipeline products received from HCPs via phone, email, Medical Information Request Form (MIRF), medical and sales field teams (MSLs, CAMs, sales representatives) for scientific exchange of information. Engage live with HCPs and KOLs via phone or video conference, responding to immediate medical inquiries. Prompt execution and completion on researching and developing unique responses for escalated, complex off-label medical information inquiries from HCPs. Identify, evaluate and gather pertinent information for documentation and triage of adverse drug events and product technical complaints to appropriate company stakeholders to comply with regulatory guidelines. Ensure customer interactions are accurately documented using Medical Information database, to share and provide analysis of information for stakeholders, including internal auditors and regulatory authorities. Conduct monthly QA review of incoming medical inquiries handled by medical affairs to report on trends, competitive intelligence and compliance requirements. Analyze the need for new standard response documents by evaluating usage and trends over time; determine when unique responses should be transferred to standard responses, as well as when standard responses should be retired.
Develop and maintain a level of medical and scientific knowledge to serve as the medical information expert for the assigned therapeutic area. Lead efforts in researching, reviewing, creating and updating Standard Response Letters (SRLs) and Frequently Asked Questions (FAQs) to ensure Medical Information database remains up-to-date with accurate, evidence-based, balanced medical information for utilization by US and Global Medical Affairs in responding to inquiries received from external stakeholder such as Key Opinion Leaders (KOLs) and HCPs. Champion the needs of our customers by evaluating new scientific literature to interpret and convey most significant scientific data on CSL Behring products. Collaborate with Global Medical Affairs in preparation for launches and support of pipeline and product portfolio and take the lead in the development of medical documents housed in an electronic platform for broad access by Global Medical Affairs counterparts. Collaborate with various internal colleagues across all levels, including senior marketing executives and commercial development partners to analyze database for strategic relevance and optimization.
Lead and maintain responsibility for medical aspects of review and approval of promotional and medical affairs materials for accuracy and clinical relevance of medical information by applying regulatory, therapeutic and clinical knowledge. Function independently as a core medical member of PRC with signing and approval authority. Actively participate in Promotional Review Committee (PRC) and Medical Legal Regulatory (MLR) meetings and document all reviews in ZincMaps, articulating information and feedback to a variety of audiences, and effectively negotiating with counterparts from cross-divisional or functional areas, including Therapeutic Area Directors, Marketing, Legal, Regulatory, and Business Operations. Propose solutions that continue to maintain marketing objectives while mitigating regulatory risk in a timely manner for execution by US Commercial Operations. Serve as primary medical contact and provide expert consultation on relevant medical aspects and clinical considerations to Marketing, Sales, Medical Affairs, Learning and Development, Commercial Development teams for CSL Behring products including new campaigns, launch preparations and pipeline development. Lead the medical strategy in close collaboration with Therapeutic Area Directors on core claims guide and concept reviews, which is the basis of all promotional messages for new and soon to be approved products. Maintain comprehensive understanding of relevant advertising/promotional regulations and guidance including those related to labeling, product promotion and scientific exchange for drugs and devices.
Lead the development, implementation and maintenance of slide libraries and guidance notes for Therapeutic Area Directors and field Medical Affairs personnel in the US and for use by Global Medical Affairs for pre-launch and post approval scientific exchange to influence successful adoption of CSL Behring products in all markets. Lead the strategy development, evaluation and building of Medical Affairs resources for the US and Global Medical Affairs for effective presentations in close collaboration with Therapeutic Area Directors. Monitor and facilitate the update of these educational resources throughout the life cycle of the product.
Respond to escalated customer inquiries from vendor partners and ensure successful and prompt resolution. Supervise the daily activities of vendor partners to guarantee quality performance and services. Responsible for the overall coordination of vendor agents in alignment with CSL business, campaigns, products and services. Ensure adherence of all vendor agents to CSL Behrings company policies and federal regulations. Create training materials, conduct training and contribute to vendor partner oversight. Conduct monthly QA review for accuracy and compliance along with identification of trends, competitive intelligence and further assessment of response documents/database. Identify gaps and training needs of the vendor partners for continued success in representation of CSL Behrings commitment and services to our external stakeholders.
Requirements:
PharmD degree a must; advanced degree a plus.
Previous hospital or clinical setting experience required.
3 or more years of experience in the pharmaceutical industry; medical information experience preferred (fellowship or residency in the pharmaceutical industry may apply)
Advanced knowledge of pharmacotherapy
Knowledge of biomedical publication searching and literature review
Strong working knowledge of FDA regulations regarding drug promotion and the dissemination of medical and product information; previous promotional review experience preferred
Excellent verbal and written communication skills with experience in medical writing preferred
Ability to conduct professional and compassionate interactions with healthcare professionals and consumers regarding serious and complex disease-states or products
Worker Type:
Employee
Worker Sub Type:
Regular
