Regulatory Science Operations Team Submission Support Associate
This is an exciting opportunity for a highly motivated individual to join our Regulatory Science Operations Team.
The Regulatory Science Operations Team Submission Support Associate will be part of a dynamic operational support team with a focus on regulatory study support activities.
There will be opportunities for cross-training to gain experience in several types of roles, including review coordination, document management, quality control review, data management, and administrative support.
Job Summary
Coordinate responses to agency questions according to milestones
Provide coordination and support of dossier review within the department
Dossier Template management
The individual may also assist in other processes within the team, including:
Citation support for documents and manuscripts using EndNote software
Data transcription and formatting raw study data in preparation of statistical analysis
Redaction of technical documents for public access copies
Database management and tracking
Job Qualification
B.S. or B.A. degree, or equivalent, strongly desired
Ability to work on several projects simultaneously, strong communication skills to clarify priorities
Excellent organizational skills and record keeping ability
Ability to work in a team environment, demonstrating a willingness to help others
Strong problem-solving skills, willingness to learn, and disposition to adapt to change
Excellent listening, written, and verbal communication skills
Technology-focused, demonstrating strong keyboard and data entry skills
Strong knowledge of MS Word, Excel, Outlook, Adobe Acrobat
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