Pharmaceutical Compliance Associate
Job Summary
To support the global Cross Border Engagement Review process, the part-time remote Associate, Global Compliance External Engagement will manage CBER submissions, coordinate reviews with stakeholders, and provide compliance recommendations to US-based employees.
Key responsibilities include:
- Independently manage and administer the CBER process, ensuring all submissions are complete and compliant
- Coordinate reviews and interact with CBER Committee Reviewers and Local Country-level Reviewers regarding submission queries
- Conduct initial reviews of CBER requests to determine compliance with healthcare laws and internal policies
Required qualifications:
- Minimum of one year of experience in the pharmaceutical industry, preferably in compliance or legal affairs
- Knowledge of U.S. healthcare rules related to payments and engagements with healthcare professionals
- Bachelor's degree is required
- Experience managing complex processes and high-risk reviews
- Ability to work independently and make sound decisions under time constraints
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