Janssen Research & Development, LLC. is recruiting for an Associate Director, RIM Data Standards, Governance & Operations. This position can be located in the United States (Malvern/Chesterbrook, PA; Spring House, PA; Titusville, NJ), Europe (Leiden, Netherlands; High Wycombe, United Kingdom; Allschwil, Switzerland or Beerse, Belgium).
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research and Development, LLC. is part of the Janssen Pharmaceutical Companies.
The Associate Director, RIM Data Standards, Governance & Operations works in partnership with the GRA teams at the global, regional, and local levels, and with other key business partners and external third parties including suppliers, support teams and Regulatory Authorities as needed. This position identifies and recommends improvements to business processes, regulatory data, data definitions and technology with input from Subject Matter Experts (SME). This position works to align business processes to an enterprise data strategy to ensuring that the solution provides the ability to identify, prioritize, and execute the data and analytics initiatives supporting GRA business outcomes.
- Assesses processes to ensure that organizational responsibilities are met for quality, delivery, and effectiveness. · Develops opportunities for business process improvement.
- Lead and facilitate the compliance and implementation of EMA SPOR IDMP as well as future regulatory authority SPOR implementations.
- Identify gaps and develop reusable IDMP assessment frameworks. Additionally, they will need to investigate and understand how other parts of the organization are using IDMP data. The role could expand to encompass other elements of the IDMP program including supporting data curation/remediation.
- Participate in the conception and development of the technical data warehouse solution, including vision, scope, and system architecture.
- Lead and collaborate with peers to create detailed functional specifications, design models and schemas, and system workflows from which the data fabric will be developed and implemented.
- Partner with peers and leadership to develop strategic goals and direction needed to continuously enhance the regulatory data fabric, related processes and ensure measures and results support end-user and data analytics requirements.
- Collaborate with peer groups and stakeholders to create data process pipelines for data ingestion and transformation, data modeling, documentation, and version control.
- Lead data discovery discussions with stakeholders, conduct data model reviews, and map the business requirements to logical and physical data modeling solutions.
- Maintains effective and timely interactions with FA contributors.
- Assists in technical training of GRA team members & provide ongoing guidance to ensure internal standards/procedures are adhered to.
- Determines the scope of the submission requirements for tool maintenance and development.
- Supports the implementation of new and updated software.
- Manages data governance processes. Makes and publishes decisions. Ensures that decisions made follow the regulatory guidelines and internal standards/policies.
- Aligns data governance practices across Janssen R&D.
- Oversees the initiation and deployment of special projects and activities to meet changing regulatory requirements.
- Creates a top down and strategic approach to the development of Business Systems Architecture to meet the strategic business needs of GRA.
- Participates in external industry cross industry forums and works to influences best practices. Maintain expertise and proficiency in the various application areas. Maintain current knowledge of industry trends and standards.