Regulatory Affairs Data Entry Specialist

3 weeks ago


Foster City, California, United States LanceSoft Full time
Job Title: CMC Regulatory Affairs Data Entry Specialist

Job Summary:
We are seeking a highly detail-oriented and organized Regulatory Affairs Data Entry Specialist to join our team at LanceSoft. The successful candidate will be responsible for performing data entry using Gilead RIM System to enter relevant information to support key CMC RA stakeholders. The role involves working collaboratively to support the team by executing routine data entry, such as the input of submission related dates, regulatory assessment comments. The ideal candidate will have a strong understanding of data management and entry, with experience in complex information systems.

Key Responsibilities:
  • Perform data entry using Gilead 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.

Requirements:
  • Familiarity with data entry into complex information systems.
  • 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.
  • Basic understanding of role of Regulatory Affairs and regulatory requirements in a limited number of areas.
  • Scientific background preferred.
  • Biologics experience is a plus.

Preferred Qualifications:
  • At least 3 years of experience in data management and entry.

Why Join Us:
This role is a great opportunity for someone who is passionate about advancing therapeutics against life-threatening diseases, while working with a collaborative team in Regulatory Affairs. We encourage applicants who are detail-oriented and eager to contribute to our data processes.

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