![Gilead Sciences, Inc.](https://media.trabajo.org/img/noimg.jpg)
Senior Associate, Global Regulatory Operations Quality Review
1 month ago
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.
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.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. 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.
Medical Writing is a global, dynamic, and diverse team residing within Global Regulatory Affairs. We work collaboratively to advance the strategy and create high-quality documents for successful regulatory submissions, by bringing our passion for science, discovery, and innovative strategic thinking into our daily work. Our team of highly skilled Medical Writing and Quality Review professionals support the authoring and quality review for a variety of clinical and regulatory documents. 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:
- Serves as one of the primary points of contact for department scheduling of projects. Ensures projects are resourced in a timely manner in accordance with business need and vendor outsourcing strategy. May evaluate document review scope and estimate required review time. Escalates to more senior team members if special document strategy is needed.
- Collaborates with more senior team members to implement resourcing strategy.
- Participates in automation and optimization of resourcing processes.
- Routinely monitors the inbox and resourcing tool. Responds to general queries and acts as a liaison between team, stakeholders, and vendors.
- Engages with vendor business manager(s) and vendor staff as needed. May participate in meetings, taking minutes, following up on action items, delivering feedback, escalating issues, and coordinating training refreshes.
- May perform Quality Assurance activities to ensure vendor work complies with Gilead document standards, with input or supervision as needed.
- Updates department metrics with supervision.
- Efficiently manages contractor onboarding/offboarding and provides input on relevant training roles.
- Reviews vendor invoices for accuracy and tracks vendor utilization.
- Typically does not develop project timelines; however, understands timeline inputs and deliverables and standard timelines. Facilitates document handoff and completion delivery as needed. Escalates timeline negotiations as needed.
- Participates in team meetings by presenting vendor updates, outsourcing metrics, and other relevant topics.
The position may be assigned additional responsibilities in support of day-to-day operations within the department according to the business needs.
You Will Need:
- An understanding of the drug development process and regulatory document landscape.
- Experience with clinical regulatory documents is preferred. Relevant experience could include technical data review or scientific review experience in biotechnology or pharmaceutical industries.
- Responsive and diplomatic communication skills.
- 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.
- 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.
U.S. Education & Experience
- PharmD/PhD with some relevant experience.
- MA/MS/MPH/MBA 2+ years' relevant experience.
- BA/BS with 4+ years' relevant experience.
- Experience preparing and/or contributing to regulatory, scientific, and/or medical documentation is strongly preferred.
Rest of World Education & Experience
BA/BS or advanced degree in life sciences or related field with some related work experience in the biopharma industry, e.g., clinical R&D, regulatory affairs, quality, or other related discipline.
The salary range for this position is: $115, $149, Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
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.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
-
Foster City, California, United States Gilead Sciences, Inc. Full timeSenior Associate, Global Regulatory Operations Quality ReviewUnited States - California - Foster CityGilead 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...
-
Foster City, California, United States Gilead Sciences Full timeJob DescriptionGilead Sciences, a leading biopharmaceutical company, is seeking a highly experienced Senior Director to lead its Commercial Biologics Quality Control team. As a key member of the organization, you will be responsible for providing strategic leadership and overseeing daily operations to ensure the success of our commercial biologics...
-
Quality Assurance Regulatory Specialist
1 week ago
Foster City, California, United States R&D Partners Full timeA leading biotechnology organization is seeking a Regulatory Affairs Specialist (CMC) to enhance the Data Administration team. This position offers a hybrid work arrangement.Key ResponsibilitiesConduct data entry utilizing internal systems to accurately input and maintain essential product details for cross-departmental collaboration.Collaborate effectively...
-
Senior Director, Medical Review
3 months ago
Foster City, California, United States Gilead Sciences, Inc. Full timeSenior Director, Medical Review (MR)United States - California - Foster CityGilead 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...
-
Senior Medical Review Specialist
1 day ago
Foster City, California, United States Gilead Sciences Full timeJob SummaryGilead Sciences is seeking a highly skilled Medical Review Director to join our team. As a key member of our organization, you will be responsible for overseeing the medical review of individual case safety reports (ICSRs) and line listings for marketed and investigational products.Key ResponsibilitiesEstablish and maintain recognition as an...
-
Foster City, California, United States Gilead Sciences, Inc. Full timeSenior Associate, Global External Manufacturing, Small Molecule Drug Substance (DS)United States - California - Foster CityGilead 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...
-
Foster City, California, United States Gilead Sciences, Inc. Full timeSenior Research Associate II Biologics Quality Control (Commercial Analytical Operations)United States - California - Foster CityGilead 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...
-
Foster City, California, United States Gilead Sciences, Inc. Full timeAssociate Director, Analytical Regulatory Sciences, Systems & Operations in CMC Regulatory AffairsUnited States - California - Foster CityGilead 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...
-
Associate Director, Regulatory Affairs
1 month ago
Foster City, California, United States Gilead Sciences, Inc. Full timeAssociate Director, Regulatory Affairs - InflammationUnited States - California - Foster CityGilead 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...
-
Senior Vice President of Safety Operations
4 days ago
Foster City, California, United States Milestone Technologies, Inc. Full timeFTE Role - Hybrid EnvironmentW2 Employment OnlyPOSITION OVERVIEWThe Vice President/Senior Vice President of Safety and Pharmacovigilance will be responsible for managing all elements of clinical and commercial drug safety as well as safety operations for Milestone Technologies, Inc. This role requires a leader who can effectively guide a safety department...
-
Regulatory Compliance Associate
1 week ago
Foster City, California, United States R&D Partners Full timeJoin a leading biotechnology firm as a Regulatory Compliance Associate focused on CMC (Chemistry, Manufacturing, and Controls) to enhance our Data Administration efforts.Key ResponsibilitiesConduct data entry utilizing internal systems to accurately input and maintain essential product details for various stakeholders.Collaborate effectively with the...
-
Senior Vice President of Safety Operations
4 days ago
Foster City, California, United States Milestone Technologies, Inc. Full timeFTE Role - Hybrid Work EnvironmentW2 Employment OnlyPOSITION OVERVIEWThe Vice President of Safety and Pharmacovigilance will be responsible for directing all facets of clinical and commercial drug safety and operational safety for Milestone Technologies, Inc. This role demands a leader who can manage a safety division and collaborate effectively with a...
-
Clinical Operations Associate
1 week ago
Foster City, California, United States Integrated Resources, Inc Full timeJob Title: Clinical Project Associate - IIJob Location: Not specifiedJob Duration: 12 Months (Possible extension)Pay Rate: $40 - $45/hour on W2FUNCTION:Clinical Operations – Biomarker and Bioanalytical OperationsPosition Overview:The Clinical Operations team is tasked with the global execution of all Phase I - IV clinical trials across various therapeutic...
-
Foster City, California, United States Mirum Pharmaceuticals Full timeJob SummaryMirum Pharmaceuticals is seeking a highly experienced Vice President, Drug Safety to lead the development and implementation of global safety strategies across both clinical development and commercial products.Key ResponsibilitiesProvide leadership and management for the infrastructure of the Drug Safety and Pharmacovigilance department.Develop...
-
Head of Regulatory Affairs for Advertising
4 days ago
Foster City, California, United States Milestone Technologies, Inc. Full timePosition OverviewThe Senior Director of Regulatory Affairs for Advertising & Promotion will lead, guide, and provide strategic direction on all advertising and promotional initiatives, ensuring adherence to regulations, alignment with approved product registrations, and compliance with company policies throughout the product lifecycle. This role will...
-
Senior Vice President of Clinical Operations
1 week ago
Foster City, California, United States Gilead Sciences Full timePosition OverviewThe Senior Vice President of Clinical Manufacturing plays a crucial role in the advancement of clinical production initiatives. At Gilead, we are dedicated to enhancing global health outcomes. For over three decades, we have confronted significant health challenges, including HIV, viral hepatitis, COVID-19, and cancer, tirelessly working to...
-
Senior Vice President of Safety Operations
1 week ago
Foster City, California, United States Milestone Technologies, Inc. Full timeFTE Role - Hybrid environmentW2 OnlyPOSITION OVERVIEWThe Vice President of Safety and Pharmacovigilance will be responsible for directing all facets of clinical and commercial drug safety and safety operations for Milestone Technologies, Inc. This role requires a leader who can manage a safety department and collaborate with a diverse team of clinical,...
-
Foster City, California, United States Gilead Sciences, Inc. Full timeSenior Director, CMC Regulatory Affairs Biologics Project LeadUnited States - California - Foster CityGilead 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...
-
Director, Regulatory Affairs
1 month ago
Foster City, California, United States Gilead Sciences, Inc. Full timeDirector, Regulatory Affairs - InflammationUnited States - California - Foster CityUnited States - New Jersey - ParsippanyGilead 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...
-
Senior Manager, Quality Assurance
2 months ago
Foster City, California, United States Gilead Sciences, Inc. Full timeSenior Manager, Quality AssuranceUnited States - California - Foster CityGilead 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...