- Responds to unsolicited medical requests regarding Gilead products from HCPs, members of the public, and internal Gilead colleagues. Responses are provided promptly 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 global resources in collaboration with local affiliate teams (TA specialist team).
- Identifies, reports, and records adverse events and product complaints promptly.
- Provides a medical review for promotional and medical materials
- Contributes to the development of MI strategy and represents MI cross-functionally
- 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
- 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 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.)
- Execute and drive global initiatives and actions in a timely way to advance the provision of MI to improve patient care
- Participate in global and regional MI activities and projects in line with global and regional strategic MI plans
- TA Specialist is the medical reviewer of promotional (e.g., PRC) and medical materials (e.g., MRC).
- 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, 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
- 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
- Advanced Pharmacy, Nursing or Medical/ Life Sciences degree
- Experience in MI preferred or comparable experience within a healthcare/clinical environment required
- Experience in the pharmaceutical industry or a MI vendor required
- Experience in medical review of promotional and medical materials required
- Please NOTE: This position is located Foster City, CA, must be local or willing to relocate
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Medical Information Specialist: Senior Manager - Foster City, United States - BioSpace
Description
Job DetailsMedical Information Specialist: Senior Manager -HIV Prevention (PrEP) and COVID-19
United States - California - Foster City
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the company's five core values. That's because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
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.
We empower our leaders to step up, share ideas, listen, learn, and lead. We're welcoming bright, diverse, and imaginative minds; we're nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.
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.Job Description
Job Overview:
For additional benefits information, visit:
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
For jobs in the United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. 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 for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
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