Senior Associate, Global Regulatory Operations Quality Review

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.