Clinical Research Regulatory Affairs Manager
Job Description:
- Oversees reputed company 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 reputed company 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 reputed company, 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
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