Responsible for building, optimizing, and leading a Best-in Class Medical Information function and team. Manage Medical Information across all product offerings, including budget and all processes related to cross-functional areas. The ideal candidate will also have experience in medical writing to support creation of standard response letters and managing external vendors; potentially an outsourced medical information call center.
- Develop Medical Information strategy and plan in collaboration with Director of Medical Information in alignment with global medical strategy.
- Provide oversight of scientific and medical information to address unsolicited inquiries from healthcare professionals, patients, and other stakeholders.
- Develop, maintain, and provide high-quality medical and scientific information, including standard response letters (SRLs), customized responses, and medical frequently asked questions (FAQs) to both internal and external stakeholders.
- Provide oversight for all activities related to the delivery of accurate, scientifically balanced, and timely responses to unsolicited inquiries from healthcare professionals and other stakeholders to ensure medical information responses address stakeholder needs.
- Ensure accurate, appropriate and timely availability of medical information in full regulatory compliance to medical science liaisons, clinical teams, and senior management.
- Take leadership where appropriate and engage with cross-functional team to ensure HCPs and patients needs/issues are resolved with the ultimate goal of ensuring patients receive the best care.
- Ensure documentation of medical information inquiries and responses comply with relevant Standard Operating Procedure (SOP)/ Work Instructions and regulatory guidelines.
- Provides subject matter expertise for SOP development and process improvements for managing Medical Information function. Ensure SOP’s accurately reflect best industry practices and that compliance with SOP’s is documented for all processes.
- Monitor adverse events and product quality complaints and processes in accordance with SOPs and work instructions.
- Establish monthly or quarterly (MI) reports and support the Medical Affairs Operations and Program Management functions in development of relevant reports and dashboards including key performance indicators (KPIs).
- Build and maintain strong working relationships with cross-functional teams (i.e. Pharmacovigilance, Regulatory Affairs, and Supply Chain functions, Subject Matter Experts) and key internal and external stakeholders.
- Maintain a thorough understanding of disease biology, scientific data, and competitive data in order to develop scientifically rigorous and high-quality products and programs.
- Ensure all MI activities follow applicable company, governmental, and industry guidelines globally.
- Develop and maintain outstanding knowledge of Lantheus products, competitor products, and relevant disease areas.
- Ensure that all interactions and activities adhere to corporate and healthcare compliance guidance in all activities, including those related to scientific interactions with internal and external groups, and responses to unsolicited requests for medical/scientific information.
- Oversee external partners, including the Medical Information call center, to execute using agreed-upon process.
- Train Medical Information team and call center specialists on processes and disease state/product information.
- Identify, on a continuous basis, areas of improvement for call center operations (e.g. compliance, efficiency, quality) and work closely with internal stakeholders and external partner to prepare solutions.
- Lead the overall medical affairs insight gathering process in order to collate intelligence gathered through MSLs and other channels and provide insights to internal stakeholders on unmet needs/data gaps and work collaboratively towards innovative solutions.
- Actively demonstrates and promotes the Lantheus values of accountability, quality, efficiency, customer service, collaboration and safety.
Typical Minimum Skills and Experience and Education
- Advanced healthcare professional degree (e.g. PharmD, PhD, or MD) strongly preferred.
- Overall combination of 10+ years scientific and/or clinical experience in industry with 5+ years in Medical Information activities.
- Must have excellent relationship management skills.
- Project management training or one or more years of experience.
- Working knowledge of current regulatory guidelines.
- Demonstrated strong interpersonal and communications (verbal and written) skills with both internal and external partners.
- Organizational awareness (e.g., inter-departmental relationships, business priorities), including significant experience working cross-functionally and in global teams.
- Knowledge of oncology and/or radiopharmaceuticals, medical imaging field, and diagnostics agents preferred.
- Demonstrated ability to efficiently assimilate diverse and complex medical and scientific data from sponsored or clinical studies and articulate summary information in verbal and written form.
- Occasional travel based on educational or business purposes.