- 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.
- 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.
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Senior Manager, Global Regulatory Operations Quality Review - San Mateo, United States - Gilead Sciences
Description
Senior Manager, Global Regulatory Operations Quality ReviewUnited States - California - Foster CityUnited States – Remote
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. Gilead's 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 company's five core values. That's 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
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
We empower our leaders to step up, share ideas, listen, learn, and lead. We're welcoming bright, diverse, and imaginative minds; we're nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. Join Gilead and help create possible, together.
Job 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.
Gilead has established employee resource groups to support diversity and inclusion and provides a competitive benefit package including flexible work options and exceptional support for the family and the individual.
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 include:
You Will Need:
For additional benefits information, visit:
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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 for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' 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.
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