Description
Gilead Sciences is a research-based biopharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet medical need including virology, oncology, and inflammation. With each new discovery and investigational drug candidate, we seek to improve the care of patients around the world living with life-threatening disease.
Quality Review is an exceptional team of highly skilled professionals within the Global Regulatory Operations (GRO) department which resides in the Regulatory Affairs organization. We collaborative with our stakeholders to advance Gilead’s business strategy and ensure high-quality submissions to regulatory health authorities. Quality Review also supports audits and process improvements. We are dedicated to attracting new talent with diverse backgrounds and experiences and committed to providing individual development and growth opportunities while promoting a healthy work-life balance.
Key responsibilities
- Serves as the primary point of contact for GRO Quality Review department scheduling. Ensures projects are resourced in a timely manner in accordance with business need and vendor outsourcing strategy. Evaluates document review scope appropriately and estimates review time. Develops document review strategy if needed.
- Collaborates with QR Portfolio Strategy Lead to develop resourcing proposal for approval and implementation.
- Drives automation and optimization of resourcing processes.
- Proactively identifies and communicates potential department workload peaks. Ensures all staff is utilized and not overburdened.
- Routinely monitors the GRO Quality Review inbox and resourcing tool. Responds to general Quality Review questions and acts as a liaison between Quality Review, stakeholders, and vendors.
- Engages routinely with vendor business manager(s) and vendor staff, including leading meetings, taking minutes, following up on action items, delivering feedback, escalating issues, and training refreshes.
- May perform Quality Assurance activities to ensure vendor work is in line with Gilead Quality Review standards, with input or supervision as needed. Updates, develops, and presents metrics to ensure vendors are performing at a high level. Consults Continuous Improvement Lead as needed.
- Efficiently manages contractor onboarding/offboarding and provides input on relevant training roles. Ensures vendor staff training is in compliance.
- Reviews vendor invoices for accuracy and determines vendor efficiency. Tracks vendor utilization and ensures outsourcing stays within budget. Provides budget tracking for GRO as needed.
- Typically does not develop project timelines; however, understands timeline inputs and deliverables and GRO Quality Review standard timelines. Negotiates timelines with stakeholders as needed. Facilitates document handoff and completion delivery as needed.
- Participates in GRO Quality Review team meetings presenting vendor updates and outsourcing metrics.
- May represent GRO Quality Review team on cross-functional initiatives with input or supervision from a more senior colleague.
The GRO Quality Review Senior Manager may be assigned additional responsibilities within the department as needed.
Education and Experience
- Experience reviewing a wide range of regulatory deliverables or relevant experience. Strong data review and/or editing background preferred. Relevant experience could include technical data review or scientific review experience in biotechnology or pharmaceutical industries.
- A strong understanding of the drug development process and regulatory document landscape.
- Responsive and diplomatic communication skills.
- The ability to make risk-based decisions and develop risk mitigation strategies.
- The ability to prioritize competing tasks and projects.
- The ability to understand the needs of a variety of teams and individuals, manage expectations, and use various communication styles to work effectively with teams.
- The ability to continuously anticipate and solve problems, as well as adapt to changing priorities and ambiguity.
- The ability to lead and influence programs, projects and/or initiatives.
- Proficiency in Microsoft Office suite (including Word, Visio, Project, PowerPoint, Excel, and PowerBI), as well as Adobe Acrobat, SharePoint, Smartsheet, and a regulatory document management system such as Veeva.
- PharmD/PhD with some relevant experience.
- MA/MS/MBA with 6+ years’ relevant experience.
- BA/BS with 8+ years’ relevant experience.
- A minimum of 5+ years of relevant experience in a medical writing/clinical submissions environment reviewing documents for regulatory submissions.
