Senior Manager, R&D Information Systems

Senior Manager, R&D Information Systems
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

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Position Overview

• Implements and manages business applications determined by immediate manager in the Development organization.
  
• Applies implementation methodology to deliver the application to the business.
  
• May coordinate and/or direct the work activities of staff or other team members on project-oriented tasks.
  
• Assesses and analyzes business requirements and recommends technical solutions and implementation plans.
  
• Understands and performs validation efforts in accordance with legal requirements (e.g. GxP).
  
• The Sr. Manager will be able to apply their technical expertise to make a major contribution to a specific business unit or department.
  
• Manages design, build, and deployment of Regulatory software platforms, applications, and tools, as well as support and administration of these systems.
  
• Provides technical expertise in electronic information management and submission tools and strategies to assist other members of Development during submission preparation and delivery.
  
• Lead Tier 1*, Tier 2†, and Tier 3‡ system activities. Manages and mentors team members to ensure they meet the full requirements of their role.
  
• Conducts professional appraisals for team members and effectively manages performance.
  
• Work across geographic regions to provide technical support in conjunction with other members of DevOps Systems.
  

Supervisory Responsibilities

• May provide direction to subordinates based on general policies and management guidance
  
• Work is reviewed upon completion for adequacy in meeting objectives
  
• Interprets and executes policies and procedures that typically affect subordinate organizational units
  
• Recommends modifications to operating policies
  

Key Responsibilities

• Interacts frequently with other functional areas
  
• Manages complex architecture within the document management and publishing tools to ensure adherence to appropriate regulatory guidelines.
  
• Participates in both group and cross-functional process improvement and development initiatives
  
• Represents the organization as a technical contact for projects and systems
  
• Serves as a System Administrator (privileged user) on Regulatory systems
  
• Administers and manages configurations for Regulatory systems
  
• Reviews and assesses system changes and releases
  
• Develops and implements system solutions
  
• Develops and documents system processes
  
• Conducts business requirements analysis
  
• Troubleshoots technical issues and resolves tickets
  
• Works closely with the training team within DevOps to provide analysis and documentation support for training, as needed
  
• Maintains a proficiency and expertise with the tools and processes associated with regulatory submissions
  

Qualifications

• Requires 8+ years of experience with a BA or BS degree in a technical discipline or equivalent, or 6+ years with an MS or MBA degree, and at least 3 years of experience in computer system software management and application support.
  
• In-depth technical knowledge of Regulatory systems, including but not limited to: Regulatory Information Management systems (eg, Veeva Vault, Documentum, CARA, DocuBridge, Liquent InSight), Collaboration tools (eg, SharePoint, Office 365), and Cloud solutions (eg, Amazon Web Services, Azure)
  
• Familiarity with global Regulatory submissions and document management processes
  
• Strong computer skill set and working knowledge of electronic submission requirements
  
• Strong knowledge of computer system validation
  
• Must have a working knowledge of Word, Word templates, Adobe Acrobat and standard Office tools
  
• Must be able to prioritize and balance multiple tasks simultaneously to achieve goals and satisfy customers
  
• Must be able to work effectively within an environment that has quickly changing processes, priorities, and deadlines
  
• Detail oriented
  
• Strong troubleshooting\\problem analysis skills
  
• Strong interpersonal skills, including teamwork, facilitation, and negotiation
  
• Experience working with cross-functional teams
  
• Strong verbal and written communication skills and the ability to describe and present information
  
• Must be able to master new software and technical skills as the industry and the company evolves
  
• Familiarity with pharmaceutical development and Regulatory global submissions
  

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.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.\u200b

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

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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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