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Senior Associate, Regulatory Operations

Employer
Gilead Sciences, Inc.
Location
Foster City
Salary
See job description.
Closing date
Aug 8, 2021

View more

Discipline
Other, Legal/Regulatory Affairs
Position Type
Full Time
Job Type
Other
Organization Type
All Industry, Pharma


Senior Associate, Regulatory Operations
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


Gilead is a research-based biopharmaceutical 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.

Job Overview:

  • As a member of the Regulatory Operations team, performs routine and complex document formatting in Word and PDF. Has the ability to report process complex documents of all types with little supervision and involvement by manager.
  • Adopts responsibility for document processing activities occurring under their guidance.
  • Identifies issues and proactively engages manger for a resolution.
  • Manages routine projects of low complexity.


Job Responsibilities:

  • Prepares a variety of routine and non-routine Word and PDF formatting including utilization of Document Processing supporting tools for submission-ready documentation.
  • Performs filing and data retrieval functions as directed, or in conjunction with departmental SOPs.
  • Participates in supporting and promoting current routine electronic initiatives in moving the company forward with electronic submissions and electronic archives.
  • Confident interface with projects managers, regulatory product managers, and or content authors to discuss routine and non-routine documentation preparation and content.
  • May take significant responsibilities in submission planning meetings to become familiar with the submission priorities.
  • Performs workflows and procedures regarding document tracking, indexing, retrieving and disseminating of regulatory agency submissions as defined by Regulatory Operation management.
  • Carries out project tasks under the direction of manager. Provides the status of their ongoing projects and Document Processing activities to the manager when required.
  • Provide training to others on software tools used and educating authors on Document Processing procedures and submission-ready requirements.
  • Leads projects of high complexity. Makes independent and appropriate decisions.
  • May lead cross-functional projects and represent Reg Ops at project meetings. Proactively communicates the status of ongoing projects and submissions to the manager, and suggests solutions to problems


Knowledge & Skills:

  • Demonstrates continued success leading involving regular Word and PDF formatting, with high-quality work output that requires minimal supervision.
  • Expert technical knowledge of current systems (Word, Acrobat, document management system, Document Processing supporting tools)
  • Demonstrates knowledge of how system implementations work.
  • Demonstrates strong project management skills, with the ability to manage the tasks of more junior associates.
  • Demonstrates a depth understanding of requirements for documentation sent to agencies by Gilead.
  • A consistent demonstration of attention to detail, timeliness, and accuracy is critical.


Education & Experience:

  • 6+ years of relevant experience and a BA or BS.
  • 5+ years of relevant experience and an MS.
  • Relevant experience includes electronic document management systems, global regulatory submissions, or other experience directly related to Regulatory Operations.



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/Senior-Associate--Regulatory-Operations_R0021308-1





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