The Director of Europe Medical Information and Communications will lead the Medical Information and Communications Function for region Europe at Clovis Oncology. This includes oversight of the external call center’s activities to support Europe, training and managing the appropriate staff in Europe, and establishment of a call center in Europe in collaboration with the Global Director of Medical Information. The Director will be responsible for developing European and country specific standard response letters (SRLs) and frequently asked questions (FAQs) for use by the call center, and adapting globally developed SRLs and FAQs. The position interacts with and supports the European Market Access team in regard to HTA submissions. Additional responsibilities include the development and adaptation of tools, resources and training for the Medical Science Liaison team, congress planning and development of congress booth materials.
The Director coordinates with Europe Medical Science Liaisons to communicate results from related medical information requests, and interacts collaboratively with Europe Commercial Leadership, Clinical Development Teams, corporate partners and others. This position has extensive scientific and clinical knowledge and experience. He/She also has knowledge of information systems and vendors.
• Manage the Europe Call Center and vendors.
• Provide clinical, product and process training to all call center staff and monitor the quality of service.
• Contribute to medical review of Clovis externally presented materials and promotional materials.
• Maintain the Medical Information Management system for tracking and Management of Medical inquiries and responses related to company products.
• Knowledge and experience with regulatory issues relating to medical information including those related to unsolicited requests for unapproved uses, and ensuring dissemination of medical information meets European and country specific regulatory guidelines in collaboration with country Medical Directors.
• Generate appropriate reports and dashboards documenting categories/types of information requests and the responses to these requests.
• Develop standard response letters and create and update frequently asked questions responses.
• Partner with the Pharmacovigilance (PV) team to ensure that the reported AEs on commercial products are captured and triaged to PV in a timely manner.
• Partner with Clovis Quality Assurance (QA) team to ensure that the reported product quality complaints on commercial products are captured and triaged to QA in timely manner.
• Maintain clinical and technical expertise in the relevant therapeutic areas.
• Lead the development, implementation, and maintenance of best practices, standard operating procedures, policies, work instructions, technologies, etc. to maximize compliant, effective and efficient delivery of Medical Information services.
• Partner with other Clovis Oncology functions, in order to ensure medical information needs are met.
• Lead the identification of, planning and development of necessary tools and resources specific to the European MSL team in collaboration with Global Medical Communications and the country Medical Directors.
• Create new and update existing tools and resources in a timely manner, including but not limited to slide decks and digital assets.
• Participate in congress planning.
• Deliver key congress materials such as session searches, session assignments, pre-meeting reports, nightly reports, post meeting executive summaries, pre meeting data reviews/preparation, Post meeting live data reviews.
• Attend scientific conferences to enhance therapeutic knowledge and contribute to execution of Medical Affairs conference deliverables.