Regulatory Systems Consultant

We are seeking a freelanceRegulatory Systems Project Manager/Consultantto join our team. The successful candidate will be responsible for regulatory systems projects for our clients.

The project manager should be capable of overseeing the implementation, maintenance, and optimization ofVeeva Vault RIM Suite. They should be able to work with clients to put together appropriate regulatory systems strategies and roadmaps and estimate resource requirements.

They should also be able to identify opportunities to enhance RIM capabilities and improve regulatory systems processes with the client, ensuring efficient data flow and communication between platforms. They will need to collaborate with cross-functional client teams to integrate RIM systems with other business applications and manage the integration of applicable regulatory systems and electronic document management systems (EDMS).

Experience required:

1. Degree in Life Sciences, Information Technology, Regulatory Affairs, or related field
2. Extensive experience in regulatory operations within the pharmaceutical industry
3. Proficiency in Veeva Vault RIM Suite, eCTD management systems, and other regulatory systems
4. Strong analytical, problem-solving, and decision-making abilities
5. Understanding of Electronic Document Management Systems (EDMS)
6. Experience in managing RIM capabilities and driving process improvements
7. Experience in managing regulatory data and integration
8. Excellent project management skills
9. Ability to work in a client-facing environment with excellent written and verbal communication

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