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Regulatory Affairs Specialist

2 months ago

Foster City, California, United States LeadStack Inc. Full time
Company Overview:
LeadStack Inc. is a highly regarded staffing services provider, recognized as one of the fastest-growing certified minority-owned businesses in the nation. We pride ourselves on being a certified Great Place to Work and collaborating with esteemed Fortune 500 companies.

Position:
Regulatory Affairs Associate II

Location:
Foster City, CA

Contract Duration:
12 months

Compensation:
$40/hr - $60/hr

Key Responsibilities:
  • Conduct data entry utilizing Gilead Information Systems to accurately enter and maintain essential product information for cross-functional teams.
  • Collaborate effectively with the RA CMC team to ensure timely deliverables by executing routine data entry and performing quality control on that data and related reports.
  • Ensure data completeness, accuracy, and consistency throughout.
  • Support project initiatives aimed at enhancing information systems for RA CMC and stakeholders relying on RA CMC data.
  • Develop and acquire necessary system skills and knowledge, with training provided by management and colleagues.
  • Work under the general supervision of more experienced Regulatory Affairs CMC Systems professionals.

Required Knowledge & Skills:
  • Familiarity with data entry processes in complex information systems.
  • Experience with web-based Electronic Data Capture (EDC) and data management systems.
  • Experience with Veeva Vaults is preferred, particularly with the RIM Vault.
  • Strong verbal and written communication skills, along with excellent interpersonal abilities.
  • Exceptional organizational skills and the capability to manage multiple concurrent projects under tight deadlines.

For more information about current opportunities at LeadStack, please visit our website.