Job Description
Prepares and/or reviews regulatory documents to support clinical trial submissions. With guidance from senior staff, provides regulatory support for more complex projects.
Acts as a Clinical Trial Regulatory Manager (CTRM) on straightforward projects independently and complex regulatory projects under the guidance of senior staff.
Ability to administratively and technically/scientifically review core scientific documentation and feedback gap analysis to customers.
Prepares and maintains core clinical trial submission dossiers in accordance with applicable regulatory requirements.
Interacts with internal and external clients to provide regulatory guidance and strategic input for clinical trials.
May strategically plan and perform/support European centralized submissions and facilitate global submissions with minimal supervision.
Understands the Scope of Work, deliverables and budget for any given project and ensure timelines are met.
Ensur...