Job Reference: BBBH24227
Job Duration:
Start date: a.s.a.p
Description:
An excellent opportunity has arisen for an experienced RegulatoryInformation Manager (RIM) to join a leading Biopharma client based in the Oxfordshire area. The ideal person will have strongregulatory and VEEVA Vault background, as well as line management.
Responsibilities:
*Act as ambassador for Vault RIM across R&D
*Manage communication regarding company Vault RIM, including newsletters and maintaining and updating the intranetpage for the system
*Create and maintain 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;
*Serve as the Regulatory point of contact for R&D Records and Information Management activities and strategies
*Interfaces with system end-users to identify necessary ad hoc regulatory/compliance related system updates and resolves requests relevant to in-scope activities;
*Work closely with IT and vendor (Veeva) to support Veeva Vault RIM system updates and releases;
*In conjunction with IT, manage useraccounts in the company Vault RIM including user permissions and security profiles;
*Manage Veeva Vault RIM configuration requests by working with IT, Veeva and functional GRA representatives;
*Support IT in validation testing as needed;
*Develops SOPs,Manuals, or other training materials for Veeva Vault RIM and works collaboratively with QA and Regulatory Affairs teams.
Experience Required:
*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 AuthorityGuidelines (FDA, EMA, etc.)
*Ability to multitask effectively in a fast-paced environment with often shifting priorities
*Ability to work independently with minimal supervision or direction
*Excellent verbal and written communication skills
*Experience with extensive document archiving is required
*Experience managing vendors, contractors, and direct reports
For further details about this role, please contact Tim Barratt on or email a copy of your CV to tbarratt@keypeople.co.uk
Industry: Pharmaceuticals
Salary: £50000 - £68000 per annum + car allowance and bonus
Salary Benefits: car allowance and bonus
Vacancy Type: Permanent
Job Skills: RIM, regulatory, information, management, publishing, regs
Contact Name: Tim Barratt
Website: -
Direct Application URL: -