Senior Manager, Regulatory Information Management

Recruiter
Key People Limited
Location
Oxford, UK
Salary
Competitive
Posted
20 May 2019
Closes
04 Jun 2019
Ref
1146508643
Contract Type
Permanent
Hours
Full Time
An excellent opportunity has arisen for an experienced Regulatory Information Manager (RIM) to join a leading Biopharma client based in the Oxfordshire area. The ideal person will have strong regulatory 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 intranet page 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 user accounts 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 Authority Guidelines (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

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