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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
Regulatory Information Management (RIM) is a core function within Gilead's Global Regulatory Affairs organization. RIM acts as a critical strategic partner by providing process improvement, information management and other technical solutions to support their internal business partners and stakeholders for all regulatory-related activities. This includes partnering with Regulatory Affairs and other business functions to interpret and analyze business needs, processes, and specifications to develop, enhance, and maintain regulatory information management processes, systems architecture, platforms, applications, functionalities, and outputs to support global regulatory activities and meet health authority requirements.
One strategic component of RIM is to provide automation solutions that support the global RA business process across RIM and external systems. The RIM Automation team designs, develops, tests, validates, maintains, and improves automation solutions, which involves additional responsibilities for preparing and delivering operating instructions and user training, compiling and managing technical documentation, analyzing and evolving systems capabilities, and partnering with other Gilead development systems and information technology groups to enhance and simplify the overall user workflow and effort for time consuming tasks. RIM Automation defines and sets the automation and technology strategy for Global Regulatory Affairs. The RIM Automation team also supports ongoing maintenance and management of existing automation for various regulatory activities.
You will act as the Business Analyst lead for RIM Automation, which will include defining and managing a program to discover automation needs with functional department leadership, defining and managing an intake system/process for automation requests that includes a process for solution assessment and prioritization, complex business process design or improvement, automation and technology strategy, platform development, end user support, and data management. You may manage one or more direct reports, which will include offshore business analyst resources. You will work with your manager to define business and technical objectives for the RIM Automation area. You will investigate technical project feasibility and provide input into project cost, benefit estimates, and project resource needs. Where applicable, you will coordinate infrastructure requirements with other development systems and/or IT partners. You will work directly with internal customers to diagnose business process and technical needs of increasing complexity. You will author automation process, business process and technical documentation when needed. Where applicable, you may also author user acceptance or validation test cases. You will typically be involved in setting the short- and longer-range automation and technology strategy for Global Regulatory Affairs.
EXAMPLE RESPONSIBILITIES:
Works with manager and internal user groups to define business and technical objectives for RIM Automation. Participates in setting the short- and longer-term automation and technology strategy for Global Regulatory Affairs.
Manages the establishment of programs and process to discover automation needs with functional department leadership on a regular basis.
Takes a lead working with various regulatory functions and teams to evaluate their automation and related needs.
Defines and manages an intake system/process for automation requests that includes a process for solution assessment, prioritization and user feedback.
Leads evaluation of current and future state automation solutions to meet business needs and objectives, which can include business process design, data / information needs, data standards, data management and governance requirements, reporting functionalities, tools, templates, standards, systems, applications, and any other relevant technologies.
Works with other development systems and/or IT partners to evaluate business needs, plan for changes, other updates, and/or maintenance, and create and implement roadmaps and action plans to address business needs.
Reviews business specifications with internal users, stakeholders, and partners to ensure appropriateness and alignment.
When needed, conducts research into project feasibility and/or provides input into project costs, benefit estimates, and project resource needs.
Documents or oversees documentation of changes / updates to regulatory business processes, databases, other systems, platforms, and/or applications according to automation business requirements and standards.
Authors automation business process, technical documentation, user experience and/or test cases associated with automation solutions
May train regulatory systems and users on automation solutions, platforms, applications, functionalities, business process design, and other related areas.
May support other regulatory functions and colleagues with information management or related actions to aid audit and inspection activities.
May manage one or more direct reports, which may include offshore business analyst resources.
Ensures own work complies with established practices, policies, and processes, and any regulatory or other requirements.
REQUIREMENTS:
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
U.S. Education & Experience
MA/MS/MBA with 6+ years’ relevant experience.
Preferred degree would be in Computer Science, Data Science, Information Management or Business Systems, but other science subjects will also be considered.
BA/BS with 8+ years’ relevant experience.
Preferred degree would be in Computer Science, Data Science, Information Management or Business Systems, but other science subjects will also be considered.
Significant business process and technical support experience for regulatory business processes and regulatory systems and applications in a business environment, including experience leading small to medium-size projects and project teams.
Proven effectiveness managing business process and technical projects and teams in a business environment.
Rest of World Education & Experience
BA/ BS or advanced degree with significant business process and technical support experience for regulatory business processes and regulatory systems and applications in a business environment, including experience leading small to medium-size projects and project teams. Proven effectiveness managing business process and technical projects and teams in a business environment.
Knowledge & Other Requirements
Experience with cloud-based end user solutions such as Veeva, Salesforce, Oracle, SAP, SharePoint Online functionality is strongly preferred
Experience working with custom automations or RPA-based automations and associated tool set, such as Blue Prism, Automation Anywhere and UI Path is ideal
Demonstrated interest in automation technology, innovation, artificial intelligence, machine learning, natural language processing and intelligent automation.
Demonstrated ability to envision and drive successful automation solutions that are unique and appropriately scaled to fit “real world” operational problems.
Demonstrated ability to describe processes in a clear, understandable manner to colleagues and non-technically minded users.
Has advanced knowledge of regulatory business processes, information applications and systems best practices and tools and has shown ability to apply these to improve business efficiencies and effectiveness.
Demonstrated ability to be a fast learner.
Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
Demonstrates strong analytical thinking skills, attention-to-detail, strong communication and writing skills, project management skills and proficiencies with Microsoft Office suite, as evidenced through accomplishments in past roles.
Strong communication and organizational skills.
Ability to lead and influence programs, projects and / or initiatives.
When needed, ability to travel.
The salary range for this position is: $154,020.00 - $199,320.00. 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:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
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 [email protected] for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' (https://www.eeoc.gov/employers/eeo-law-poster) poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf)
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION (https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf)
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 (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) 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.
Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all Canada, Australia, Singapore, and Hong Kong employees and contractors to be fully vaccinated against COVID-19 as a condition of employment. T he health of our employees, contractors, their loved ones, our partners and the communities and people we serve is a top priority. Vaccination is the most effective way currently available to deliver on that priority.
The purpose of the vaccination requirement is to minimize the spread of COVID-19 in the workplace and support the health and safety of our communities. A person is considered fully vaccinated two weeks after the second dose of a two-dose vaccine or two weeks after 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 an accommodation.