Job Description
Job Overview:
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.
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.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
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.
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.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Overview:
The Manager, MRC Operations is responsible for facilitating the medical review committee review process of scientific materials intended for use by medical affairs team members during scientific exchange. The individual will assure process compliance and efficiency of the MRC review cycle, including assessing that materials submitted for review are ready to progress, creating meeting agendas, managing meeting logistics and facilitating review meetings. This role is responsible for annotating materials during MRC review meetings, working with medical content creators to reconcile comments and progress materials through approval and release within established timelines.
The MRC process involves various cross-functional internal resources (e.g., Legal, Medical Information, Regulatory, USMA, GMA), and it is important that the MRCs are managed to function as teams that meet deadlines and adapt to unique challenges. To this end, this role will be responsible for managing all aspects of offline and live reviews and optimal tracking of materials during their life cycle and providing training to medical content creators and agency partners on processes and procedures. This role will also provide oversight of vendor resources supporting the MRC operational review process.
This position reports into the Senior Director, Medical Content Strategy as part of the Global Medical Strategy & Operations (GMSO) organization in Medical Affairs.
Key Responsibilities:
Manage the end-to-end review, approval and expiration lifecycle of medical materials, utilizing the content management system (Veeva Vault MedDocs)
MRC meeting management and facilitation: This includes but is not limited to agenda planning, calendar management, expedited reviews, leadership escalations, and annotating materials/capturing consensus outcomes during live discussion meetings
Oversee and track electronic review cycles to meet approval timelines and other key MRC process-related metrics on monthly/quarterly basis
SME and point of contact for MRC operational process and Veeva MedDocs system-related questions including, but not limited to metadata completion, review workflow management, naming convention standardization, & other content-related requirements
Lead facilitation of MRC Operational Process Trainings to stakeholders (document owners, agency partners, etc.) and development of new and maintenance of existing training materials
Lead MRC review material prioritization efforts in partnership with Medical Strategy content creators & AD, Medical Content Strategy & Enablement role
Support, or lead when appropriate, medical content readiness initiatives/workstreams applicable to Scientific Content Ecosystem.
Collaborate cross-functionally with Regulatory, Medical, Legal, Document Owners, and Agencies
Oversight and management of vendor resources supporting MRC review meetings and operational process
Involved in project work supporting continuous improvement and innovation
Education and Experience:
Bachelor's Degree and 5 years of experience OR Masters' Degree and 3 years of experience
Experience working with medical review committees or promotional review committees preferred
Experience with content management systems (Veeva MedDocs or Veeva PromoMats) preferred
Excellent verbal, written, and interpersonal skills
Ability to resolve problems logically, quickly and proactively
Understanding and application of principles, concepts, practices and standards applicable to Medical Review
Must possess strong project management and organizational skills
Adept to working in a complex and cross-functional environment
Possesses a growth mindset and ability to embrace change and pivot when needed
Ability to influence people without direct authority
Entrepreneurial attitude is essential, e.g. challenges the status quo and takes calculated risks
Learning, agility and growth mindset
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
For jobs in the United States:
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, 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 ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
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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.
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For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
