Clinical Research Regulatory Affairs Manager
McKesson
full-time
Posted on:
Location Type: Remote
Location: Tennessee • United States
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Job Level
Tech Stack
About the role
- Oversees all aspects of the regulatory operations for Sarah Cannon site Clinical Operations and manages the regulatory department
- Responsible for developing and implementing short- and long-term strategies for regulatory compliance
- Ensures Sarah Cannon adheres to and maintains FDA regulatory compliance
- Oversees any regulatory audit
- Works closely with department directors and/or primary investigators, industry sponsors and other outside entities
- Manages, directs, plans and schedules activities and programs for the regulatory department
- Establishes and enforces procedures for trial teams and sites compliance
- Develops and implements regulatory policies and procedures for the site Clinical Operations team
- Manages the regulatory affairs for multiple clinical trials according to FDA and GCP guidelines
- Manages relationships between industry partners and the FDA regarding regulatory compliance and auditing
Requirements
- Bachelor's Degree
- 1+ year work experience with 5+ years' preferred in clinical research corporation and regulatory team - education may be substituted for partial experience
- Knowledge of scientific and clinical research terminology
- Knowledge of FDA and GCP guidelines
- Knowledge of organizational policies, procedures, and systems
- Advanced skills with MS Office products including Excel, Word, Outlook
- Experience meeting strict deadlines and supervising team members
Benefits
- Total Rewards package includes comprehensive benefits to support physical, mental, and financial well-being
- Competitive compensation package determined by several factors including performance, experience and skills
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory complianceregulatory auditregulatory policiesGCP guidelinesclinical trials managementscientific research terminologyorganizational policiesproceduresMS OfficeExcel
Soft Skills
leadershiporganizational skillscommunicationteam supervisionstrategic planningrelationship managementdeadline management
Certifications
Bachelor's Degree