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Regulatory Operations Associate II

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Job Description

Publishing:

  • As a member of the Regulatory Operations team, performs routine and non-routine submission compilation and publishing activities associated with generating hard copy and electronic submissions.
  • Publishes and validates large and complex submissions with some supervision from senior publishers and managers. Adopts responsibility for defined activities such as acting as Lead Publisher for a non-routine submissions, trainer, or SME for an area of publishing knowledge.


Archiving:

  • As a member of the Regulatory Operations team, archives high volume, semi-complex international documents, as well as routine documents. Publishes Advertising and Promotional submissions. Identifies basic issues and proactively engages senior associates for a resolution.


Document Processing:

  • Routine and complex document formatting and report processing of all types with some supervision and involvement by senior associates and manager.


Adopts responsibility for defined activities such as acting as Lead Document Processor for a non-routine activities, trainer, or SME for an area of document processing knowledge.

Specific Responsibilities:

Publishing:

  • Prepares a variety of routine and non-routine submissions including utilization of publishing tools for electronic and paper submission generation, scanning.
  • Performs filing and data retrieval functions as directed, or in conjunction with departmental SOPs.
  • Supports current routine electronic initiatives in moving the company forward with electronic submissions and electronic archives.
  • May interface with project managers, regulatory product managers, and or content authors to discuss routine and non-routine submission preparation and content.
  • May, with guidance, participate 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 Operations management.
  • Leads routine projects. Attends project meetings and takes guidance from senior colleagues in making decisions. May participate in cross-functional projects. Proactively communicates the status of ongoing projects and submissions to the manager.


Archiving:

  • Archives a variety of routine International documents for the electronic and paper archives.
  • Prepares OPDP submissions including utilization of publishing tools for electronic and paper submission generation.
  • Performs filing and data retrieval functions as directed, or in conjunction with departmental SOPs.
  • Supports current routine electronic initiatives in moving the company forward with electronic archives.
  • Performs workflows and procedures regarding document tracking, indexing, retrieving and disseminating of agency correspondence and submissions as defined by Regulatory Operation management.
  • Leads routine projects. Attends project meetings and takes guidance from senior colleagues in making decisions. May participate in cross-functional projects. Proactively communicates the status of ongoing projects to the manager.


Document Processing:

  • 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.
  • Supports current routine electronic initiatives in moving the company forward with electronic submissions and electronic archives.
  • Interface with projects managers, regulatory product managers, and or content authors to discuss routine and non-routine documentation preparation and content.
  • Participate 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 senior colleagues. Provides the status of their ongoing projects and Document Processing activities to the manager when required.
  • May assist and/or provide training to others on software tools used and educating authors on Document Processing procedures and submission-ready requirements.


Leads routine projects. Attends project meetings and takes guidance from senior colleagues in making decisions. May participate in cross-functional projects. Proactively communicates the status of ongoing projects and Document Procession activities to the manager.

Knowledge, Experience & Skills:

Publishing:

  • Demonstrates an ability to lead projects involving regular submissions with minimal supervision.
  • Demonstrates knowledge of how system implementations work.
  • Demonstrates an understanding of eCTD.
  • A consistent demonstration of attention to detail, timeliness, and accuracy is critical.


Archiving:

  • Demonstrates an ability to lead projects involving regular archiving with minimal supervision.
  • Demonstrates knowledge of how process implementation work.
  • Demonstrates an understanding of document management.
  • A consistent demonstration of attention to detail, timeliness, and accuracy is critical.
  • Demonstrates an understanding of OPDP eCTD.


Document Processing:

  • Demonstrates an ability to lead projects involving regular Word and PDF formatting, with high-quality work output that requires minimal supervision.
  • Advanced technical knowledge of current systems (Word, Acrobat, document management system, Document Processing supporting tools).
  • Demonstrates knowledge of how system implementations work.
  • Demonstrates an understanding of requirements for documentation sent to agencies by Gilead.


A consistent demonstration of attention to detail, timeliness, and accuracy is critical.

  • 4+ years of relevant experience and a BA or BS.
  • 3+ 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.

About Gilead:

Gilead Sciences, Inc. 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.

Meet the team:

https://regulatoryaffairs-careers.gilead.com/

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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 contactcareers@gilead.comfor assistance.

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

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.

Regulatory Operations Associate II

Foster City, CA
Full Time

Published on 10/23/2018