Intern supporting Government Affairs & Regulatory Law Group in legislative process analysis and research tasks. Engaging in client meetings and preparing tracking reports throughout the internship.
About the role
- Clinical Trial Regulatory Specialist ensuring compliance and quality in regulatory submissions for clinical trials. Working in a team to deliver and provide expertise in core regulatory activities.
Responsibilities
- Performs assigned activities within the CTRA team
- Responsible for providing delivery and expertise in regulatory core submissions
- Prepare the technical components of a regulatory core submission
- Conducts Quality Control reviews of documents
- Attends client meetings as needed
Requirements
- Minimum of a BA or BS preferred
- Experience in working to applicable GxPs (e.g. GVP, GCP, ISO 14155)
- Excellent presentation, documentation, influencing, and interpersonal skills (both written and spoken)
- Proficient computer skills in Microsoft Office Suite, web-based systems, voicemail, Email and Internet
Benefits
- supportive and engaged line management
- technical and therapeutic area training
- peer recognition
- total rewards program
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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