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An Exciting Contract Opportunity for Data Entry (Regulatory Affairs ) with one of the Leading Biopharmaceutical Clients in Cambridge, UK
Title: Data Entry - (CMC Regulatory Operations Associate)
Location: Cambridge, UK- Hybrid role (3 days onsite required)
Duration: 6 Months
Top 3 Required Skill Sets:
- Familiarity with data entry into complex information systems
- strong verbal and written communication skills
- experience with Veeva Vault, including RIM
Top 3 Nice to Have Skill Sets:
- Basic understanding of Regulatory Affairs;
- scientific background preferred;
- biologics experience is a plus
Specific Job Responsibilities
- Perform data entry using Client RIM System to enter relevant information to support key CMC RA stakeholders.
- Work collaboratively to support the team by executing routine data entry, such as the input of submission related dates, regulatory assessment comments.
- Ensure completeness, correctness and consistency of data.
- Responsible for acquisition of required system skills and knowledge; training supported by manager and peers.
- Work is performed under the general supervision of more senior Regulatory Affairs CMC professionals.
Knowledge & Skills
- Should have familiarity with data entry into complex information systems.
- Should have experience with Veeva Vaults, experience with the RIM Vault preferred.
- Strong verbal and written communication skills and interpersonal skills.
- Excellent organizational skills and ability to work on multiple concurrent projects with tight timelines are required.
- Basic understanding of role of Regulatory Affairs and regulatory requirements in a limited number of areas is required.
- Scientific background preferred.
- Biologics experience is a plus
