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