RIM Senior Manager

Highly Competitive
  1. Permanent
  2. Senior/Director & VP
  3. United Kingdom
Oxford, Oxfordshire
Posting date: 15 May 2019
RA.JB.23338_1557917538

An international biopharmaceutical is currently recruiting a RIM Senior Manager to their team in Oxford. This organisation focuses on improving patients' lives by identifying, developing, and commercializing meaningful products that address unmet medical needs, specialising in the fields of sleep and hematology/oncology. This vacancy offers the exciting opportunity to work with a dynamic and leading biopharmaceutical organisation.

Job Responsibilities:

  • Acting as ambassador for the company RIM across R&D, working to leverage optimal value for the company from the Veeva Vault RIM suite of products
  • Managing communication regarding the company's RIM, including newsletters and maintaining and updating the intranet page for the system
  • Creating and maintaining excellent relationships across GRA, R&D contributing groups, and IT, ensuring information management needs are met and requests for information are handled in a timely fashion;
  • Serving as the Regulatory point of contact for R&D Records and Information Management activities and strategies
  • Working closely with IT on schedules, document delivery, program risk, and mitigating strategies around use and version releases;
  • Interfacing with system end-users to identify necessary ad hoc regulatory/compliance related system updates and resolves requests relevant to in-scope activities;
  • Working closely with IT and vendor (Veeva) to support Veeva Vault RIM system updates and releases
  • In conjunction with IT, managing user accounts in the company's RIM including user permissions and security profiles;
  • Managing Veeva Vault RIM configuration requests by working with IT, Veeva and functional GRA representatives;
  • Supporting IT in validation testing as needed;
  • Developing SOPs, Manuals, or other training materials for Veeva Vault RIM and works collaboratively with QA and Regulatory Affairs teams.
  • Managing transition from live the company's RIM training to comprehensive, module-based eLearning provided through the company's interface.

Skills and Requirements:

  • Bachelor's degree
  • Maintain Veeva Administrator's Certificate
  • Excellent communicator and team player who gets the job done - this is a hands-on position
  • Minimum 3 years of Regulatory Affairs experienced required
  • Strong understanding of Regulatory activities, projects, and processes
  • Experience in Veeva Vault Regulatory Information Management software
  • A working knowledge of Pharmaceutical/Biotech Regulatory Submission requirements as defined by ICH and Global Health Authority Guidelines (FDA, EMA, etc.)
  • Experience with extensive document archiving is required
  • Experience managing vendors, contractors, and direct reports
  • Demonstrable project management skills.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Joe Beddows at +44 203 854 2623or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

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

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