Sr Manager, Medical Information

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 evaluate clinical, biomedical, and scientific data
• Demonstrates Gilead’s core values and Leadership Commitments
• Has strong attention to detail, excellent project management and problem-solving skills, and ability to think creatively
• Good organizational and work planning skills and ability to manage multiple projects in a fast-paced environment
• Demonstrates strategic thinking. Reviews metrics regularly to identify data gaps and develops strategy for creation of relevant content in collaboration with internal partners
• Strong knowledge of, or ability to learn quickly, the TA and Gilead products
• Strong knowledge and understanding of all applicable local regulatory and legal requirements for Medical Affairs activities such as the provision of MI services

Basic Qualifications:

• Doctorate and 2+ years of relevant experience OR
• Master’s and 6+ years of relevant experience OR
• Bachelor’s and 8+ years of relevant experience OR

Preferred Qualifications:

• Advanced Pharmacy, Nursing or Medical/ Life Sciences degree
• Experience in MI preferred or comparable experience within a healthcare/clinical environment
• Experience in the pharmaceutical industry or a MI vendor
• Experience in medical review of promotional and medical materials