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12-month contract role based in Cambridge
CMC Regulatory Affairs, Data Entry Contractor Position

Specific Job Responsibilities
• Perform data entry using in-house 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