CMC Regulatory Affairs Manager
Apply NowCompany: Katalyst HealthCares and Life Sciences
Location: Tampa, FL 33647
Description:
Responsibilities:
- Perform data entry using internal company systems to enter and maintain relevant product information to support cross-functional stakeholders.
- Work collaboratively to support the Regulatory Affairs CMC team to meet deliverables and timelines by executing routine data entry, quality control of that data entry and associated reports.
- Ensure completeness, correctness and consistency of data and data structure.
- Responsible for supporting project work for enhancements to information systems for RA CMC and stakeholders who utilize RA CMC data.
- Responsible for development and 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 Systems professionals.
- Should have familiarity with data entry into complex information systems.
- Should have familiarity with web-based Electronic Data Capture (EDC) and data management systems.
- Should have experience with Veeva Vaults, experience with the RIM Vault preferred.
- Strong verbal and written communication skills and interpersonal skills.
- Excellent organization skills and ability to work on multiple concurrent projects with tight timelines are required.