Sr Manager, Medical Information

Sr Manager, Medical Information United States - California - Foster City Medical Affairs Regular

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

We are looking for a Sr Manager, Medical Information to join our team in out Foster City, CA Headquarters.

Responsibilities:

• Respond to unsolicited requests for medical and scientific information regarding Gilead products
• Researches and collaborates with cross-functional colleagues to respond to complex requests; TA specialist responds to complex requests from affiliate MI and internal colleagues
• Create, update, and participate in the review, and quality check and may approve MI response documents by local laws and regulations
• TA specialist collaborates with affiliate MI and relevant internal partners who may include medical affairs, development, regulatory, global patient safety and operations, and commercial, to manage global response topics and content
• TA specialist prepares and approves data on file to support response documents and complex requests
• Maintain document repository with regular/routine review of approved documents for new data from regulatory updates, scientific conferences, up-to-date literature searches, proactive literature surveillance, or newly published materials
• Ensuring medical and scientific accuracy of medical information content deliverables and input into the Promotional Review and Medical Review Committees
• Review and provide analysis of MI databases for trends, customer insights, and data gaps to guide content development and prepare customer interaction reports to share with internal stakeholders
• May oversee and evaluate external consultant writers
• Plan and support MI booths at the scientific congress and answer scientific questions – travel may be required
• Support departmental strategic initiatives to address major activities within TA (product launches, labeling updates, patient engagement, etc.)
• Participate in global and regional MI activities and projects in line with global and regional strategic MI plans
• Collect, present, and share MI customer interaction reports, identify data gaps and develop a strategy for the creation of relevant content
• Participate in the development or update of department policy guidelines and SOPs
• Lead/co-lead and partner with MI teams on global and local MI initiatives and team projects
• TA Specialist may have direct line management responsibilities for one or more non-permanent colleague e.g., contractor or MI fellow, with responsibilities as defined in the management track

Knowledge and Skills:

• Excellent written, verbal, and interpersonal communication skills, and the ability to work well in multidisciplinary teams, across geographies
• Ability to create and provide clear communication of scientific data for different audiences, including members of the public
• Knowledge of applicable regulatory and legal requirements for the provision of MI in the pharmaceutical environment, with an understanding of regional or country regulations related to the provision of MI services
• Ability to provide analysis and…