Sr Manager, Medical Information

At Gilead were creating a healthier world for all people. For more than 35 years weve 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

Every member of Gileads 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 were looking for the next wave of passionate and ambitious people ready to make a direct impact.

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Job Description

Medical Information Specialist: Senior Manager

Job Overview

• Responds to unsolicited medical requests regarding Gilead products from HCPs members of the public and internal Gilead colleagues. Responses are provided in a timely manner using approved standard documents up-to-date literature support and other resources

• Uses scientific and MI expertise to drive strategic initiatives and empower Gilead partners HCPs patients and other requestors with globally aligned resources that enable timely informed decisions and improved patient outcomes.

• Prepares local resources (affiliate MI specialist).

• Identifies reports and records adverse events and product complaints in a timely manner in accordance with SOP.

• May be asked to provide medical review for promotional and/or medical materials depending on geography or role

• Contributes to development of MI strategy and represents MI cross functionally.

Responsibilities

Routine responsibilities may include the following depending on geography:

• Respond to unsolicited requests for medical and scientific information regarding Gilead products and documents in the request handling system (MiQ).

• Researches and collaborates with cross functional colleagues to provide response to complex requests.

• Create update and participate in review quality check and may approve MI response documents in accordance with local laws and regulations.

• Collaborates with affiliate internal partners who may include medical affairs development regulatory global patient safety and operations commercial to manage global response topics and content.

• Prepares and support use of local response documents for resolution of 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.

• Understand the needs and preferences of internal and external partners and customers.

• 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 plan and support MI booths at scientific congress and answer scientific questions travel may be required. Affiliate specialists may participate in global conference support. May attend relevant sessions to enhance TA knowledge.

• Create TA and product training materials and provide training to cross functional colleagues and vendors.

• Support departmental strategic initiatives to address major activities within affiliate (product launches labelling updates patient engagement etc.)

• Execute and drive global initiatives and actions in a timely way to advance the provision of MI to improve patient care.

• May participate in events from external MI organisations across the pharmaceutical industry.

• Identify report and record adverse events and product complaints in a timely manner in accordance with SOP.

• Participate in global and regional MI activities and projects in line with global and regional strategic MI plans.

• Serve as department SME for one or more product(s) or TA.

• Local affiliate specialist may participate as medical reviewer for local approvals as required.

• Manage local QA processes including the evaluation of medical request reports to ensure documentation and consistency in responses.

• Collect present and share MI customer interaction reports (global or affiliate) identify data gaps and develop strategy for creation of relevant content.

• Collaborate with global MI team affiliate stakeholders to align for global content planning and therapeutic area strategy.

• Lead patient engagement initiatives such as the development of patient response documents (if local laws allow in affiliate market)

• Participate in development or update of department policy guidelines and SOPs.

• Lead/co-lead and partner with other affiliate MI teams on global and local MI initiatives and team projects.

• 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.

• Serve as liaison for all TA and department specific training for new staff members cross-functional colleagues and vendors as required.

• Manage local distributor or MI vendor including quality and compliance.

• Lead timely communication of trends customer insights and data gaps with key stakeholders.

For affiliate MI department lead without direct reports responsibilities may include the following depending on geography:

• Overall performance of the department and reports.

• Departmental compliance to local and global policies/ procedures relevant to Med Info.

• Quality and compliance of all departmental activities.

• Department audit and inspection readiness.

• QA and oversight of department and vendor.

• Report and customer interaction generation.

• Executing the global and local MI strategy.

• Development and maintenance of departmental policies and procedures relevant to MI.

• Participates as a member of the affiliate Medical Affairs leadership team; and participates in cross-functional affiliate projects/initiatives.

• Oversight of third-party vendor.

• Contribution and leadership in local and global cross-functional projects.

• Allocation of departmental resources.

• Continual improvement of the department.

• Increasing department visibility.

• Maintaining departmental budget and metrics.

• Setting direction for the department.

• Participates as a member of the affiliate Medical Affairs leadership team; and participates in cross-functional affiliate projects/initiatives.

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 and understanding of Gileads marketed and investigational products.

• Knowledge of applicable regulatory and legal requirements for the provision of MI in the pharmaceutical environment with understanding of regional or country regulations related to the provision of MI services.

• Ability to provide analysis and evaluate clinical biomedical and scientific data.

• Ability to develop and maintain good working relationships with departmental and cross-functional colleagues.

• Understanding of internal and external stakeholder needs and priorities.

• Serve as an advocate for MI affiliate or Global MI.

• Demonstrates Gileads core values and Leadership Commitments.

• Has a 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.

• Awareness of digital solutions for communicating with healthcare providers and patients.

• Previous experience with problem-solving and project management preferred.

• Preferably prior specialist in MI at local affiliate or global level with ability to draw on previous experience.

• Strong problem-solving and project management skills preferred and ability to manage multiple projects in a fast-paced environment for both self and others.

• Previous leadership experience preferred.

• Demonstrates strategic thinking. Reviews metrics regularly to identify data gaps and develops strategy for creation of relevant content in collaboration with internal partners.

• Demonstrates success in developing and maintaining good working relationships with internal and external stakeholders.

• Ability to lead trainings for departmental cross-functional colleagues and vendors. Ensures inclusion of relevant MI colleagues in medical affairs activities and trainings.

• For those who have responsibility for the work of others: demonstrated ability to manage and lead staff members.

• 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.

• Ability to actively build cross functional relationships.

• Strong knowledge and understanding of all applicable local regulatory and legal requirements for Medical Affairs activities such as the provision of MI services.

Education and Experience

• Pharmacy Nursing or Medical/ Life Sciences degree/advanced degree or equivalent.

• Experience in MI preferred or comparable experience within a healthcare/clinical environment required.

• Experience in the pharmaceutical industry or a MI vendor required.

Levelling Guide (number of years does not apply in all affiliates (outside of the United States) due to local employment laws.

Previous experience minimum 7 years preferred (may include advanced degree course)

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.