Excellent employment opportunity for a CMC Regulatory Affairs Data Entry in the Foster City CA area.
Remote If the candidate is in the Foster City CA area we would prefer that they are onsite 23 days if possible
Perform data entry using Company 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.
Experience:
Required Degree or Certification B.S. preferred
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 the role of Regulatory Affairs and regulatory requirements in a limited number of areas is required.
Scientific background preferred.
Biologics experience is a plus
At least 2 3 years of experience
Top 3 Required Skills: 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 Skills: Basic understanding of Regulatory Affairs; scientific background preferred; biologics experience is a plus
We are seeking candidates for this position who have a strong interest in data management and entry.
Please note that a significant portion of this role involves entering and managing data in complex systems.
If you are not enthusiastic about data entry tasks this position may not be the right fit for you.
We encourage applicants who are detailoriented and eager to contribute to our data processes.
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