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Gilead Sciences Inc.

Manager, Regulatory Documentation and Submissions Quality

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 Current Gilead Employees and Contractors:

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

Job Description

The Quality department resides organizationally within Regulatory Documentation and Submissions (RDS) at Gilead and provides various services including, but not limited to: quality reviews (data/content verification and consistency, style application, editing), audit readiness support, and process improvement support, to support a wide variety of regulatory submissions across all therapeutic indications.

  • Functions as the Quality Lead for complex regulatory deliverables
  • Manages all aspects of deliverable quality review (QR), including targeted training
  • Assigns and oversees QR department scheduling
  • Performs high-quality reviews of regulatory deliverables
  • Oversees Quality audit readiness
  • Supports Quality initiatives
  • Acts as a RDS Quality resource

Essential Duties and Job Functions :

  • Develops deliverable review strategy, monitors Quality timelines, informs project team if deliverable is at risk, responsible for any quality-related issues
  • Ensures Quality standards are consistently met, actively identifies areas of process/tool improvement, and provides intra-/interdepartmental training as needed
  • Monitors QR request SharePoint inbox, estimates required QR time, assigns deliverable QR Lead
  • Forecast team workload and proactively identify and communicate potential workload peaks and develop associated resourcing plan
  • Conducts Quality team meetings presenting timelines and updates of assigned deliverables alerting team of any potential resourcing issues.
  • Performs detailed and thorough QRs to ensure data integrity, internal content consistency, and completeness in a wide range if regulatory deliverables (CSRs, IBs, Protocols, CTDs, etc)
  • Performs editorial reviews to ensure style is consistent with the R&D Manual of Style and correct grammar application within regulatory deliverables
  • Closely collaborates with Audit SME and Lead Writer to oversee Quality audit preparation
  • Assists with the development and delivery of relevant training and new hire onboarding
  • Serves as a contributing author for Quality training manuals, business practices, and SOPs
  • Responds to general Quality questions, liaison between Quality and Medical Writing, and remains current with Gilead and industry Quality standards

Knowledge, Experience and Skills :

  • Understanding of Medical Writing industry guidelines and regulations with ability to identify areas of non-compliance
  • Extensive experience reviewing and editing wide range of regulatory deliverables
  • Ability to work independently on basic job duties and understands criticality and time expectations of assigned activities and prioritizes as appropriate.
  • Has developed organizational skills; is detail oriented; and able to work in a fast‑paced, deadline-driven environment.
  • Displays flexible thinking and willingness to adapt to changing approaches based on project needs and expectations.
  • Familiar with AMA Manual of Style.
  • Strong editing background/editing certification preferred
  • Has excellent verbal and written communication skills and interpersonal skills.
  • Can effectively communicate with a variety of teams and individuals, including team leadership and members of senior management.
  • Is capable of using advanced functions of various software applications, particularly the Microsoft Office Suite, Adobe Acrobat, SharePoint, and a Regulatory Document Management System.

Typically requires:

  • A minimum of 8+ years of relevant experience with BA/BS degree or 6+ years of relevant experience with MA/MS degree within clinical R&D or regulatory affairs such as pharmaceuticals/biotechnology, including a minimum of 5+ years of relevant experience in a medical writing/clinical submissions environment preparing documents for regulatory submissions.
  • Ideal candidates include those who are familiar with Phase 1 to 3 clinical protocols and clinical study reports and understand the drug development process leading to marketing applications

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 [email protected] for 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.

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