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CMC Regulatory Affairs Data Entry

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Job Location drjobs

Alexander City - USA

Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Job Description

Foster City CA
Contract Duration: 636 months
Rate: Negotiable

Responsibilities:

  • 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.

Employment Type

Full Time

Company Industry

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