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Regulatory Affairs

Associate Director, RIM Data Standards, Governance & Operations

  • Titre Associate Director, RIM Data Standards, Governance & Operations
  • Fonction Regulatory Affairs
  • Sous-fonction Regulatory Compliance
  • Lieu Wayne, Pennsylvania, United States; Malvern, Pennsylvania, United States; Leiden, South Holland, Netherlands; Titusville, New Jersey, United States; Allschwil, Basel-Country, Switzerland; Beerse, Antwerp, Belgium; High Wycombe, England, United Kingdom; Spring House, Pennsylvania, United States; Chesterbrook, Pennsylvania, United States
  • Date de mise en ligne
  • Référence 2306103529W
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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 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.

Primary Responsibilities:

  • 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.



  • Master’s degree in computer science, Engineering, or 8-10 years of equivalent work experience relevant experience supporting large scale enterprise data solutions in the healthcare industry is required.


  • Strong data analysis skills with the ability to translate data into information, and strategies into actionable plans.
  • Knowledge of quality management and/or compliance principles.
  • Knowledge of compliant implementations of enterprise-wide technology-based business capabilities.
  • Understanding of business aspects of data standards, data architecture and related governance.
  • Knowledge of external factors (standards, regulatory requirements) that impact the work.
  • Excellent verbal and written communication skills, ability to work and thrive in a multi-cultural environment, and ability to work in a matrix environment.
  • Experience leading and motivating internationally based high performance teams.
  • Experience leading projects and driving change initiatives in a global, outsourced and matrix management environment.
  • Strong decision making and problem-solving skills. Ability to manage and prioritize multiple workstreams
  • Facilitation, presentation and meeting management skills for internal and external audiences at all levels.
  • Conflict resolution/management and negotiation skills.


  • Knowledge of global regulatory affairs and in-depth understanding across and outside of regulatory affairs.
  • Knowledge of the drug development and safety business area processes.
  • Experience with vendor management.


  • This position may require up to 5-10% domestic and international travel.

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit .

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

The base pay range for this position is $129,500 - $223,100. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. The Company maintains highly competitive, performance-based compensation programs.  Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan.  The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year.  Bonuses are awarded at the Company’s discretion on an individual basis.  Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. For additional general information on company benefits, please go to: - (The compensation and benefits information set forth in this posting applies to candidates hired in the United States.)

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