Medical Information
2 weeks ago
Description
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.
Job Overview
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:
Serves as the subject matter expert for MI on Gilead Cell Therapy products and associated therapeutic area(s)
Responds to unsolicited medical requests regarding Gilead Cell Therapy 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.
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
Respond to unsolicited requests for medical and scientific information regarding Gilead Cell Therapy 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 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.
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 oversee and/or evaluate external consultant writers.
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.
Serve as department SME for one or more product(s) or TA.
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.
Lead patient engagement initiatives such as the development of patient response documents
Participate in development or update of department policy guidelines and SOPs.
Participate and support department audit and inspection readiness.
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 Gilead Cell Thearpy’s 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.
Demonstrates Gilead’s 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
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.
Strong knowledge of, or ability to learn quickly, the TA and Gilead Cell therapy’ products.
Education and Experience
An advanced degree (PharmD, MD) is preferred.
Experience in Medical Information is required.
Experience in Cell Therapy / Oncology is preferred.
Experience in the pharmaceutical industry is required.
Experience of working with MI vendors preferred.
Previous experience minimum 5 years preferred (may include advanced degree course)
Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
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