Reg Submission Coordinator (Veeva RIM & MS Projects)
syneoshealth · ARG-Remote
Descripcion del puesto
About the role
The Reg Submission Coordinator supports the preparation and filing of regulatory submissions, ensuring compliance with government regulations and meeting tight timelines.
Key responsibilities
- Prepare and submit full IND, marketing, and lifecycle maintenance applications.
- Conduct quality control reviews of documents and track them through final submission.
- Maintain regulatory databases, records, and logs according to company and client requirements.
- Attend client meetings, build relationships, and coordinate project activities with minimal supervision.
- Identify project delivery risks, propose resolutions, and mentor junior team members.
Required profile
- Demonstrated ability to process information with high reliability and quality under tight deadlines.
- Experience reviewing work of regulatory associates and coordinating with project managers.
- Ability to maintain training records and complete required trainings.
Required skills
- Veeva RIM
- Microsoft Project
- Regulatory database management
Questions fréquentes
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Publicado hace 16 horas
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syneoshealth
ARG-Remote
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