Sr Associate, Reg Documentation and Submission

Sr Associate, Reg Documentation and Submission
United States - California - Foster City

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

Senior Associate, Regulatory Documentation and Submission

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), Regulatory Affairs (RA) business process support, audit readiness support, process improvement support, and compliance monitoring to support a wide variety of regulatory submissions across all therapeutic indications.

Responsibilities of the RA Business Process Senior Associate, RDS Quality, include the following:

• Expands development and support of the software/platform (KaiNexus) utilized to manage departmental improvement initiatives.
• Performs independently as executing project manager for improvement initiatives.
• Supports the development of the RA Business Process Team.

Essential Duties and Job Functions:

• Oversees KaiNexus user training and develop training materials.
• Generates progress reports of all ongoing and planned initiatives utilizing tools in KaiNexus.
• Develops features within KaiNexus to ensure platform meets the needs of RDS tracking and reporting
• Works with project lead and stakeholders to ensure project framework, objectives, and milestones are aligned with business objectives.
• Schedules project team meetings, creates meeting minutes, develops next steps/action items, and updates and captures all project artifacts in KaiNexus.
• Drives continued team progress on multiple projects during and between meetings through meeting follow-ups, conversations, and emails.
• Supports the development and implementation of a tracking tool for RA training lists of procedural documents.
• Supports the development and implementation of a tracking tool for RA procedural documents for routine reviews and required updating.
• Supports the development and implementation of a tracking tool for RA CAPAs to ensure communication between Compliance and RA functional representative.
• Acts as a Regulatory Affairs procedural document resource.
• Actively participates in RA Business Process Team activities.
• Trains and mentors junior employees/contractors on KaiNexus system and process improvement initiative tracking.

Knowledge, Experience and Skills :

• Fluency in project management platforms/software
• Familiarity with highly regulated industry environments or drug development
• Excellent program and project management, consensus-building, and leadership skills
• Exceptional verbal and written communication skills and interpersonal skills.
• Ability to collaborate across the organizational hierarchy and cross-functionally
• Experience managing teams in a business operations or technical processes environment
• Has developed organizational skills; is detail oriented; and able to work in a fast?paced, deadline-driven environment.
• Ability to work independently on basic job duties and understands criticality and time expectations of assigned activities and prioritizes as appropriate
• Displays flexible thinking and willingness to adapt to changing approaches based on project needs and expectations.
• Capable of using advanced functions of various software applications, particularly the Microsoft Office Suite, Adobe Acrobat, and SharePoint

Typically requires:

• A BS degree
• 5+ years of relevant experience with a Bachelor's Degree
• 3+ years of experience in the biotechnology or pharmaceuticals industry
• Familiarity with KaiNexus or similar platform
• Experience with Six Sigma or other process improvement methodologies
• Experience managing and collaborating with virtual or remote teams
• Experience with SharePoint administrator activities

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 careers@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the 'EEO is the Law' 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:
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