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Regulatory Systems Business Support

Claran Consultants

Blanchardstown Road North, Dublin

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JOB DETAILS
LOCATION
Blanchardstown Road North, Dublin
POSTED
14 days ago
Regulatory Systems Business Support (RSBS) required for a leading Biopharma facility in Dublin,  responsible for managing an ongoing Veeva to Veeva regulatioly information management system migration. Ensuring all documentation, regulatory information, and submitted archives are enriched and are successfully transferred to the new RIM system.   Initially a 7 month contract.  Hybrid role.
You will be responsible for:
  • Executing planned activities within the migration plan as appropriate to ensure the project is on track.
  • Providing oversight and direction towards the mapping requirements between the two Veeva RIM systems.
  • Ensuring successful deployment of successful migration strategies
  • Ensuring compliance with all relevant regulations and internal policies throughout the migration process.
  • Providing insight and technical knowledge towards enrichment of regulatory data if necessary
  • Assisting the Systems and digital lead as necessary throughout the project
  • Assisting with migration verification strategies, risk assessment and cut-overstratergies.
  • Collaborating with stakeholders as and when necessary to gather enriched data requirements and resolve any issues or discrepancies that arise.
 
You will need to have:
  • A Bachelors degree with 3-6 years of experience in pharmaceutical/biotech industry, with 4+ years of Global Regulatory Affairs, Clinical or Regulatory Operations, supporting systems.  Or a A MSc with 2-4 years of experience in pharmaceutical/biotech industry, with 2+ years of Global Regulatory Affairs, Clinical or Regulatory Operations, supporting systems.
  • Experience within a Veeva Regulatory Information Management system is a necessity.
  • Significant knowledge of Regulatory Affairs business processes
  • Demonstrated experience managing, developing, and administering electronic document management systems, regulatory publishing systems and regulatory tracking databases
  • Strong project management and timeline management skills; ability to successfully manage multiple complex projects and associated problems and identify and manage risks
  • Excellent communication and interpersonal skills, with the ability to effectively liaise with cross-functional teams.
  • Strong presentation and communication skills, negotiation, and follow-up skills
  • Ability to provide oversight and guidance to extended team members in completing project deliverables according to agreed timelines and project plans
  • Ability to interact and network effectively with internal customers and external vendors
  • Practical operational experience of working across disciplines and across regions/countries
  • Experience in the maintenance of GxP, Annex 11 and 21 CFR Part 11 computerized systems
  • Experience in prioritizing own and others’ workload
  • Team player with excellent interpersonal skills
We would prefer for you to have:
  • Past experience with a regulatory information management migration project
  • Extensive Veeva knowledge preferably a white belt or a system administrator training.
  • The ability to work independently (with minimal supervision), as well as work in a team environment with changing timelines and priorities.
  • Ability to adhere to strict project timelines and budgets, and to advise teams and management of impacts and changes in project timelines.
 

About the Company

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Claran Consultants