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Manager, Promotional Review Committee

Employer
Gilead Sciences, Inc.
Location
Foster City
Salary
See job description.
Closing date
Dec 19, 2020

View more

Discipline
Other, Other
Position Type
Full Time
Job Type
Manager
Organization Type
Pharma


Manager, Promotional Review Committee
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. Gileads 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 companys five core values. Thats 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


At Gilead, we are driven to develop lifesaving products that make a difference for patients around the world. Everyday, we transform the promise of science and technology into breakthrough, innovative therapies that have the power to cure, prevent or treat disease. As a research-based biopharmaceutical company, we are revolutionizing healthcare by bringing medicines to patients in the areas of unmet need including HIV, AIDS, liver diseases, hematology and oncology, and inflammation and respiratory diseases. When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives.

Making an impact on a global scale

For over 30 years, Gilead has been a leading innovator in treating disease, but this expertise is just a foundation for our ambitions. As we continue to expand our scope into new disease states and new markets, we are investing in our global commercial capabilities.

Reporting to the Sr. Manager of PRC Operations, the Manager, PRC Operations has responsibility for managing the PRC process and serves as the primary point of contact for the PRC submissions for one or more Brands. Excellent project management skills and communication skills are required.

Primary Responsibilities

  • Manages logistics of meetings with PRC members including the creation of the meeting agenda
  • Facilitates review meetings including recording PRC comments during discussions
  • Coordinates the review of materials through the PRC process including reviewing submissions for completeness and accuracy
  • Tracks electronic review cycles and adherence to deadlines
  • Works with PRC manager to plan and coordinate projects and to develop department records and/or metrics
  • Works with agencies to implement revisions and submissions
  • Ensures timely distribution of materials to be reviewed.
  • Answers questions related to the submission process
  • Drives the use of the PRC master planning calendar
  • Utilizing a document management system, maintains records for potential FDA audits, ensuring they are accurate and complete
  • Collaborates cross-functionally with Regulatory, Medical, Legal, Marketing, and Agencies


Knowledge and Skills

  • 7+ years of related experience and a BS or BA degree
  • Excellent verbal, written, and interpersonal skills are required
  • General knowledge of industry practices, techniques, marketing concepts and principles
  • Must possess excellent project management and organizational skills, including written and oral communication skills, high attention to detail, high-level customer service skills, positive attitude, and resourcefulness
  • Able to take on additional responsibilities outside of primary routing duties, i.e. special projects, process improvements, etc.
  • Ability to professionally interact with senior management and stakeholders
  • Ability to resolve problems logically, quickly and proactively
  • Ability to navigate ambiguity around new process implementation and proactively looking to improve or add value
  • Must be able to consistently perform work requiring a high level of attention to detail
  • Ability to influence people without direct authority


The Gilead Difference

Everyone at Gilead is motivated by our overarching mission to discover and deliver innovative therapies that improve patient care in areas of unmet medical needs. But it's not just what we do that gives us an edge, it's how we do it. We expect everyone at Gilead to lead by example, guided by our core values:

  • Integrity - Doing What's Right
  • Inclusion - Encouraging Diversity
  • Teamwork - Working Together
  • Accountability - Taking Personal Responsibility
  • Excellence - Being Your Best


Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually, and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.


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 careers@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the EEO is the Law' 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.


To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-States---California---Foster-City/Manager--Promotional-Review-Committee_R0015983-1





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