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