Director, Regulatory Information Management Regulatory Operations

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Job description

Director, Regulatory Information Management Regulatory Operations
United Kingdom - CambridgeUnited Kingdom - Uxbridge

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


The impossible is not impossible.

It's simply what hasn't been achieved yet.

Creating Possible drives everything we do. It's evident in our mission and core values. This is how we built a culture of excellence that is fuelled by a passion for improving the lives of people around the world and advancing the care of patients suffering from life-threatening diseases worldwide.

We have an exciting opportunity within our Regulatory Operations team for a Global Director with unique strategic responsibility to lead the implementation of new Regulatory Information Management (RIM) capabilities at Gilead. This will be the first dedicated RIM specialist within the organisation and offers opportunities to directly influence the direction of the business.

Regulatory Information Management (RIM) is now recognised as the key for unlocking the value of an organisation's data. This new role offers a rare opportunity to build a small team of dedicated experts who will be committed to implementing foundational RIM capabilities. They will also raise awareness by working globally across functions and identifying opportunities to improve efficiency.

The Role

Based in the UK and reporting directly to the Senior Director of International Regulatory Operations, this role will be fundamental to setting the strategic future state of RIM within Gilead and will take immediate functional leadership for the implementation of an industry-leading, end-to-end RIM programme. This will be a multi-year and multi-phase implementation which will require close partnership with the IT and Development Systems groups, detailed coordination across the business functions as well as engagement with executive leadership.

In parallel, this role will act as the main point of contact to translate Regulatory Affairs' technology requirements to internal partners and support the comprehensive business adoption and implementation of new technology. There will be a focus on matching appropriate technology solutions to business needs while building a robust infrastructure of dedicated in-house RIM experts, crossfunctional champions and operational contract resources. Opportunities to increase the efficiency of data entry and take accountability for sustainable data quality and governance will be explored over time.

Job Responsibilities

• Be a cross-functional subject matter expert in RIM
  
• Develop and implement the business strategy required to ensure that Global Regulatory Affairs systems continue to meet ongoing and emerging business needs.
  
• Deliver expert business analysis to support the development of strategic system roadmaps
  
• Provide system and data related business change management
  
• Support data integration, data quality and the development of data governance standards to facilitate reporting and business decision making
  
• Partner with industry organisations and health authorities to influence outcomes relating to emerging requirements such as ISO IMPD
  
• Coordinate cross-functional technology awareness and education sessions
  
• Provide strategic updates and guidance to the Regulatory Affairs Senior Leadership Team as well as petitioning for endorsement of new initiatives
  
• Be a key member of the Regulatory Operations leadership team, helping to identify, propose, develop and manage improvement projects that align with Gilead's global working philosophy
  
• International travel
  
• Representation at external events
  
• Line management responsibilities such as coaching, development and performance management (FTEs and contractors)
  
• Workload, resource and budget planning and forecasting
  
• Assist with audit and inspection activities as required
  

You Will Need

• Demonstrated in-depth knowledge of Regulatory Information Management with previous experience of functional oversight of successful system implementations
  
• Detailed understanding and current knowledge of existing and planned Global regulatory agency implementations (e.g. CTIS, DADI, IRIS)
  
• Experience with xEVMPD and IDMP, including process definition and optimization for RIMS
  
• Knowledge of industry regulatory standards (eCTD, CDISC, EVPRM, SPL, ISO IDMP etc)
  
• Previous exposure to using one or other proprietary regulatory information management, document management or submission publishing solution common in Life Sciences, e.g., InSight Suite, Documentum, OpenText, Livelink or Veeva, etc.
  
• Demonstrated detailed understanding of industry trends and emerging technologies
  
• Understanding of regulatory business processes: regulatory submission, CMC, product strategy etc.
  
• Demonstrated people management skills and experience and a desire to manage the performance of others
  
• Strong strategic and "out of box" thinking, with a focus on process improvement and optimization
  
• Demonstrated strong project management skills, with the ability to manage and appropriately delegate tasks to a team and prioritization
  
• The ability to understand the needs of a cross-functional team and manage expectations
  
• The ability to balance integrity and efficiency when managing attention to detail
  
• Significant relevant years of experience
  

LOCATION

You can be based at Stockley Park or Cambridge office

Why Work at Gilead

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.

Our Core Values and Leadership Commitments:

• Integrity (always doing the right thing),
  
• Teamwork (collaborating in good faith),
  
• Excellence (working at a high level of commitment and capability)
  
• Accountability (taking personal responsibility).
  
• Inclusion (encouraging diversity)
  

Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.


For Current Gilead Employees and Contractors:
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