Clinical Reviewer

4 days ago


Silver Spring, Maryland, United States AE Strategies Full time

Job Summary:

AE Strategies is seeking a highly skilled Clinical Reviewer to join our team. As a Clinical Reviewer, you will play a critical role in ensuring the safety and efficacy of new drugs.

Key Responsibilities:

  • Pre-Approval Review: Conduct thorough reviews of new drug applications to ensure they meet regulatory requirements.
  • Post-Approval Monitoring: Continuously monitor the safety and efficacy of approved drugs, identifying potential issues and recommending corrective actions.
  • Collaboration and Communication: Work closely with cross-functional teams, including pharmaceutical companies, healthcare providers, and regulatory agencies, to ensure seamless communication and coordination.

Requirements:

  • Education: PhD in a related field from an accredited institution.
  • Experience: Proven experience in clinical research, regulatory affairs, or a related field, with a strong understanding of pharmaceutical regulations and guidelines.
  • Skills: Excellent analytical and problem-solving skills, with the ability to interpret complex data and communicate findings effectively.

What We Offer:

  • Competitive Salary and Benefits: AE Strategies offers a comprehensive compensation package, including a competitive salary, comprehensive health insurance, and retirement savings plan.
  • Opportunities for Growth and Development: We offer opportunities for professional growth and development, including training, mentorship, and career advancement.


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