Legal Information Manager

4 weeks ago

Uxbridge Greater London, United Kingdom Gilead Sciences, Inc. Full time

Medical Information - Manager
United Kingdom - Uxbridge Medical Affairs Regular Job Description
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.

Join Gilead and help create possible, together.
The Medical Information Manager is an integral member of the Medical Information (MI) team who utilizes therapeutic and product knowledge of Gilead Cell Therapy products to optimize internal and external customer communications. You will report to the Associate Director of Medical Information.
This job is fulltime and 3 days per week in the office are required.
Expectations of this role include, but not limited to, researching, and preparing responses for MI inquires, as well as interfacing with and supporting MI escalations from the Medical Information vendor/call centre:
Responds to unsolicited medical requests regarding Gilead Cell Therapy products from HCPs, members of the public, and internal Gilead colleagues. 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.
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.
Respond to unsolicited requests for medical and scientific information regarding Gilead Cell Therapy products and documents in the request handling system (MiQ)
Create, update, and participate in review, quality check and may approve MI response documents in accordance with local laws and regulations.
Collaborates with relevant internal partners who may include medical affairs, development, regulatory, global patient safety and operations, commercial, to manage global response topics and content.
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.
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 support MI booths at scientific congress and answer scientific questions – travel may be required.
Identify, report, and record adverse events and product complaints in a timely manner in accordance with SOP.
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.
Participate in development or update of department policy guidelines and SOPs.
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 understanding of regional or country regulations related to the provision of MI services.
Ability to provide analysis and evaluate clinical, biomedical, and scientific data.
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
Reviews metrics regularly, to identify data gaps and develops strategy for creation of relevant content, in collaboration with internal partners
Experience in Medical Information is required.
Experience in the pharmaceutical industry is required.
Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.We promote and support individual differences and diversity of thoughts and opinion.
Full Time/Part Time Full-Time

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