Regulatory RIM Consultant

Highly Competitive
  1. Permanent
  2. Consultant / Specialist
  3. United Kingdom
England
Posting date: 04 Oct 2020
33315

ProClinical are currently recruiting for a Regulatory RIM Consultant job working remotely. This a great opportunity to join a global pharmaceutical company. This candidate must be well acquainted with Veeva Vault.

Job Responsibilities

  • Streamline processes for uploading clinical and regulatory submission documents to Veeva Submissions Vault in preparation for submissions to the FDA. Report to Clinical Manager.
  • Work closely with multiple functions to update Veeva Vault RIM system.
  • Write and develop SOP on utilisation of Veeva Vault.
  • Identify ways to streamline document management process.
  • Identify future business needs
  • Develop, configure, and maintain mechanisms / processes within Veeva Vault for all documents and information to be transferred to RIM system.
  • Manage data migration from old EDMS to current RIM system.
  • Support User Acceptance Testing for Veeva Vault releases and carry out impact assessments.
  • Act as main point of contact for all user related issues within Veeva Vault and provide training and guidance to users.
  • Liaise with Veeva Vault vendor regards identifying future business / training needs and troubleshooting.
  • Participate in data quality reviews to ensure accurate and complete RIM data.
  • Liaise with 3rd party publishing consultancy with regards to workload, resources, and timelines.
  • Oversight of Veeva Library.
  • Implementing Veeva processes to aid regulatory submissions.

Skills and Requirements

  • Bachelor's degree in a science related field and/or other appropriate knowledge/experience.
  • More than 7 years of experience or equivalent of regulatory experience including product approval/launch.
  • Proven experience with Veeva Vault.
  • Ability to think strategically and critically evaluate risks to regulatory activities.

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical and medical device companies.

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