Polly Turner
Union,SC
Summary
Diligent Regulatory Manager with 4.5 years experience in developing effective processes and executing regulatory affairs initiatives for Clinical Research. Improved processes and assisted product development in meeting regulatory requirements. Maintained and followed up on records of regulatory information and submissions. Works well with consulting cross-functional teams on minimizing regulatory risk. Goes above and beyond to manage priorities and problem-solve with quick turn-around expectation. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Overview
5
5
years of professional experience
Work History
Regulatory Manager
Velocity Clinical Research
08.2023 - Current
- Manage a team of Regulatory Specialists.
- Support the maintenance of Electronic Regulatory Files (Advarra eReg, CRIO eReg).
- Prepare and support the preparation of study-specific protocol, informed consent form, and other documents reviewed by the IRB.
- Collaborate with cross-functional teams to ensure seamless integration of regulatory requirements.
- Implemented training programs to increase staff awareness of regulatory requirements and best practices.
- Mentored junior staff members, fostering talent development within the regulatory department.
- Drove continuous improvement initiatives within the department by analyzing processes, identifying opportunities for optimization, and implementing best practices.
- Conducted thorough Quality Control Reviews of technical documentation to ensure alignment with regulatory standards.
Senior Specialist, Regulatory
Velocity Clinical Research
10.2020 - 07.2023
- Enhanced team productivity by implementing efficient project management strategies.
- Streamlined internal processes for improved operational efficiency and cost savings.
- Developed comprehensive training programs for new hires, resulting in faster onboarding and better overall performance.
Assistant Office Personnel
Primary Care Of Union, P.C.
04.2019 - 08.2019
- Worked closely with office manager reviewing daily and month-end transactions.
- Accounts Receivable, Accounts Payable, and data entries made into QuickBooks.
- Cut checks for payroll and various operating expenses.
- Used EMR (Harris CareTracker and Amazing Charts) to input patient information, create appointments, process payments, and connect with staff members.
- Developed medical inventory log.
Education
Bachelor of Science - Accounting
Converse College
Spartanburg, SC05.2020
Skills
- Regulatory Submissions
- Document Management
- Inspections
- Quality Assurance
- Root Cause Analysis
- Management Collaboration
Timeline
Regulatory Manager
Velocity Clinical Research
08.2023 - Current
Senior Specialist, Regulatory
Velocity Clinical Research
10.2020 - 07.2023
Assistant Office Personnel
Primary Care Of Union, P.C.
04.2019 - 08.2019
Bachelor of Science - Accounting
Converse College
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