Manager MRC Operations
Manager MRC Operations
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$ 146540 - 189640
1 Vacancy
Job Description
At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID19 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 lifechanging 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.
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 were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID19 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 lifechanging 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.
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 Operationsis 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 crossfunctional 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 endtoend 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 processrelated metrics on monthly/quarterly basis
SME and point of contact for MRC operational process and Veeva MedDocs systemrelated questions including but not limited to metadata completion review workflow management naming convention standardization & other contentrelated 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 crossfunctionally 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:
Bachelors 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 crossfunctional 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
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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 disabilitygenetic information or characteristic gender identity and expression veteran status or other nonjob 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 theKnow 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 apply via the Internal Career Opportunities portal in Workday.
Required Experience:
Manager
Employment Type
Full-Time
