Regulatory Affairs Specialist
4 weeks ago
The Regulatory Affairs CMC (Chemistry, Manufacturing, and Controls) – Data Administrator Contractor will play a key role in supporting the RA CMC team by managing product information within Gilead Information Systems. This position involves routine data entry, quality control, and report generation to ensure the completeness, correctness, and consistency of data. The role will also involve supporting project work for enhancements to information systems and developing system skills and knowledge.
Key Responsibilities:
- Data Entry and Management:
- Perform data entry using Gilead Information Systems to enter and maintain relevant product information.
- Ensure data completeness, correctness, and consistency across all entries and data structures.
- Collaboration and Support:
- Collaborate with the RA CMC team to meet deliverables and timelines through effective data entry and quality control.
- Support cross-functional stakeholders by providing accurate and timely data reports.
- Quality Control:
- Execute quality control measures for data entry and associated reports to ensure accuracy and reliability.
- Project Support:
- Assist in project work related to enhancements of information systems for RA CMC and other stakeholders utilizing RA CMC data.
- Develop and acquire necessary system skills and knowledge through training provided by the manager and peers.
- Supervision:
- Work under the general supervision of senior Regulatory Affairs CMC Systems professionals to ensure alignment with project goals and standards.
Knowledge & Skills:
- Familiarity with data entry into complex information systems.
- Experience with web-based Electronic Data Capture (EDC) and data management systems.
- Proficiency with Veeva Vaults, with experience in the RIM Vault being preferred.
- Strong verbal and written communication skills.
- Excellent interpersonal skills to collaborate effectively with cross-functional teams.
- Exceptional organizational skills and the ability to manage multiple concurrent projects with tight timelines.
Qualifications:
- [Educational qualifications required]
- Previous experience in a similar data management or regulatory affairs role is preferred.
- [Any additional certifications or requirements]
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