Regulatory Affairs Systems, Data Governance Senior Manager

Job Type:Full Time

About CSL

With operations in 35+ nations and ~ 22,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Job Description

Position Purpose

  • Designs and implements data management solutions to drive data strategies for the organization or functions within the organization.
  • Verifies the accuracy of the data, and acts as liaison with business recommending ways to strengthen data integrity, quality and availability across the enterprise through data governance best practices and data standards. Partners with the business and BT for transformations during system or platform changes to ensure data quality, consistency and accuracy.
  • Plays a strategic role in the implementation of priority projects related to:
    • Centralizing the exchange of operational data between systems
    • Integrated, cross-platform reporting and dash boarding
    • Advanced statistical analysis and predictive modelling

Main Responsibilities and Accountabilities

  • Defines and incorporates data governance processes for Master Data Management and Data Ownership in scope of GRA processes and IT systems
  • Collaborates closely cross-functional and cross-site with Business and BT to Master Data and Data Governance initiatives
  • Identifies the needs of business partner and provides innovative recommendations for process changes and technology-enabled solutions in the area of data governance.
  • Follow-up on regulatory requirements in scope of IDMP and SPOR and contribute to implementation of processes to ensure compliance
  • Contributes to maintenance and continuously improvements of existing IT systems and databases used in or owned by GRA with focus on Data Governance
  • Development of strategies for quality data checks related to GRA systems
  • Coaches, Trains, reviews, and delegates work to lower level professionals
  • Developing and providing reporting and analysis of related GRA systems metrics and Performance
  • Analyses multidimensional datasets, drives business processes updates and leads the respective change initiatives
  • Drives cross divisional alignment in his/her domain of expertise to ensure a lean wide information model enabling executive data driven decision making on a corporate level
  • Provides expert guidance on business process and system design to support data governance and information modelling objectives

Qualifications

  • Proven experience in data management, data governance or corresponding data initiatives
  • Extended knowledge of the drug development process especially in the field of Project management, Regulatory Affairs, Pharmacovigilance, Clinical Data management and analytics,
  • Ability to handle complex problems with specific attention to details
  • Sound understanding of regulatory requirements in scope of current and future standards for submission of data to Health Authorities (e.g. IDMP, SPOR, xEVMPD)
  • Experience working in global, multicultural teams
  • Bachelor, Advanced degree in a Life Science (PhD, MD) or Business (MBA) preferred
  • 7+ years experience in the pharmaceutical industry. Research and Development, Regulatory Affairs or Regulatory Operations experience preferred