Senior Manager, Regulatory Information Management (RIM), Automation Business Analyst

Key Skills

Aartificial intelligence, Effective communication skills, Machine learning techniques, Oracle, Project management, Salesforce, SAP, SharePoint

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.