Job ID R-415957 Date posted 30/11/2021 BACK TO SEARCH RESULTS Apply

PIM Business Administrator (2 Years Contract)

Job Description Summary

As BD’s Central Regulatory PIM BA (Product Information Management System Business Administrator), you will provide steady-state operations support to a critical global regulatory compliance solution for the company.

This role serves Regulatory Affairs users within BD’s nine (9) Business Units and all geographic regions, starting with EMEA. This position works with a central regulatory team whose mission is to provide accurate product information to our regulators and health authorities while maintaining the systems, processes, training, and quality compliance aspects of the solution.

The Central Regulatory PIM BA supports RA business applications by resolving incidents and planning or participating in the implementation of system changes. This role is responsible for maintaining and supporting the business users, reporting processes, and ensuring the solution is operating appropriately on a day-to-day business basis. Additional responsibilities will include utilizing problem-solving skills to support the processes governing the solution(s), monitor performance and metrics in an ongoing capacity, and support end-user training.

This position will support the product owner and requires an individual that has a passion for big data and enjoys applying technologies to improve business operations. A demonstrated ability to engage users of our systems globally, at the “how-to” level, and to help them get the most value from our platforms is critical to success.

This role serves Regulatory Affairs users within BD’s nine (9) Business Units and all geographic regions, starting with EMEA. This position works with a central regulatory team whose mission is to provide accurate product information to our regulators and health authorities while maintaining the systems, processes, training, and quality compliance aspects of the solution.

The Central Regulatory PIM BA supports RA business applications by resolving incidents and planning or participating in implementation of system changes. This role is responsible for maintaining and supporting the business users, reporting processes, and ensuring the solution is operating appropriately on a day-to-day business basis. Additional responsibilities will include utilizing problem-solving skills to support the processes governing the solution(s), monitor performance and metrics in an ongoing capacity, and support end user training.

This position will support the product owner and requires an individual that has a passion for big data and enjoys applying technologies to improve business operations. A demonstrated ability to engage users of our systems globally, at the “how to” level, and to help them get the most value from our platforms is critical to success.

Job Description

Responsibilities:

Ongoing System Management

  • Supports maintenance of Pick List values in the application
  • Review and generates business-centric application metrics periodically
  • Approve activation/deactivation of users with technology partners
  • Help identify data quality/integrity risks and resolve/escalate as appropriate

Quality Management System

  • Author/Review/Approve business application documentation (Work Instructions)
  • Co-leads Power User forums and Change Control Board Meetings
  • Answers inquiries escalated by BUs or Regional Power Users and escalate common issues
  • Logs Power User questions or concerns for core team review
  • Develop and implement training, communication of standard tools, and processes associated with on market support
  • Coordinate regional and BU wide training and communication on subscriptions, tools, and BDX processes as appropriate

Program & Change Management

  • Support and lead Regional Regulatory communication planning and execution to communicate effectively with project teams, cross-business, multi-functional personnel
  • Establish and manage "User Group" for tools and processes to ensure effectiveness
  • Responsible for understanding and executing key change management tasks
  • Maintains appropriate documentation of tasks and activities performed

Process & Requirements Management

  • Able to determine RA user’s pain points, translate into system roadmap or manual workaround, build business justification and drive the case for change
  • Based on Business needs, helping to translate processes into executable workflows within the regulatory systems and tools
  • Ongoing management of data use cases, processes, training, SharePoint, and business requirements
  • Supports Business Unit and Regional teams with system processes

SDLC (Software Development Life Cycle)

  • Assists in application test planning and execution (PQ/User Acceptance Testing)
  • Reviews SDLC documents and participate in key workshops; ensure user requirements, business process, and design are understood/aligned
  • Act as a business test lead and develop and execute test scripts
  • Provides CSV/Validation centric input on enhancement requests

Essential Job Functions:

The following duties and responsibilities are intended to represent the work performed by the incumbent(s) in this position and are not all-inclusive.  The omission of a specific duty or responsibility will not preclude it from the position.

  • Responsible for executing Regulatory product master data governance processes/tasks related to product life cycle change control within the PIM system
  • Responsible for supporting the research/analysis product master data issues and liaising with business and technical teams to improve data quality through process improvements
  • Responsible for planning and consolidating content for key stakeholder meetings/workshops
  • Part of the central RA team that drives the strategy and execution for shared services support
  • Skilled at analytical tasks with the ability to think critically, problem-solve, and define solutions
  • Monitors and reports on performance within area of responsibility according to standards
  • Provides analysis/metrics to support continuous improvement activities and to ensure other functions have the information required to handle escalated problems
  • Able to assess processes to recommend and drive to efficient future state processes, including gaining buy-in from key stakeholders
  • Assess and provide recommendations of best practices between business units and drive to standardization of processes where possible
  • Oversight of PIM user accounts, security, groups
  • Support updates of communications, including metrics, newsletters, and town halls

Minimum Qualifications:

  • Prior experience in operations in a Product Information Management (PIM) system or Master Data Management (MDM) system
  • Excellent analytical and problem-solving skills
  • Experienced in business processes to support training and business administration
  • Excellent written and verbal communication, especially presentation and facilitation skills
  • Detail-oriented and analytical with the ability to prioritize, plan, and organize across workstreams
  • Very strong Microsoft Office Skills, especially Word, Excel, PowerBI, and Teams

Optional/Preferred Qualifications:

  • Knowledge of the European Medical Device Regulation (EU MDR) EUDAMED, U.S. FDA GUDID, and/or Global UDI Regulations preferred
  • Information Technology Infrastructure Library Foundations Certification (ITIL) preferred
  • Project Management Professional Certification (PMP) preferred
  • Lean Six Sigma Certification (Green Belt) preferred

Education and/or Experience:

  • Bachelor’s degree in science or health-related discipline
  • 3 – 7 years of professional IT or other BA related experience
  • 3 years working experience in Regulatory Affairs, Operations, Compliance, IT, or Quality
  • Prior experience in the Life sciences industry (Pharmaceutical, Medical Device, or Bio-Tech)

Physical Demands:

Use of computer, phone, ability to travel globally.

Work Environment:

Office and remote locations

Primary Work Location

BEL Erembodegem - Dorp 86

Additional Locations

POL Krakow - Business Park, POL Warsaw - ul. Cybernetyki, POL Warsaw - ul. Osmanska, POL Wroclaw - Legnicka, TUR Istanbul - Maslak-Sariyer, TUR Istanbul - Rüzgarlıbahçe Mah

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