Clinical Trial Education and Literature Review Specialist

2 weeks ago


Santa Monica, United States Fladger Associates Full time

Responsibilities:

  • Excellent employment opportunity for a Clinical Trial Education and Literature Review Specialist in the Santa Monica, CA area.
  • Fully remote role. EST is preferred
  • We are seeking a detail-oriented and analytical Clinical Trial Education and Literature Review Specialist to support the development and submission of clinical trial education materials to the Promotional Review Committee (PRC).
  • Responsible for conducting comprehensive literature reviews to assess the landscape of new and emerging medical indications.
  • The ideal candidate will work closely with cross-functional teams, including medical affairs, regulatory, and marketing, to ensure that all materials are accurate, compliant, and aligned with the latest medical research.
  • Develop, organize, and submit clinical trial education materials to the Promotional Review Committee (PRC) for review and approval, ensuring compliance with regulatory and company guidelines.
  • Provide ongoing support during the PRC review process, addressing feedback, revising materials, and ensuring timely approval.
  • Conduct thorough literature reviews to gather and analyze data on new medical indications, treatment trends, and advancements in the field.
  • Collaborate with cross-functional teams (Clinical Development, Medical Affairs, Regulatory, Marketing, etc.) to ensure educational materials align with clinical trial objectives and reflect the latest medical information.
  • Monitor and stay current on industry trends, new therapies, and scientific advancements that may impact clinical trial materials or strategic positioning.
  • Synthesize complex medical and scientific information into clear, concise educational content for internal and external audiences.
  • Assist in the development of communication strategies that effectively educate healthcare professionals about clinical trials, investigational products, and new medical indications.
  • Ensure all educational materials are updated and consistent with the latest clinical trial data and regulatory requirements.
  • Maintain a comprehensive database of clinical trial education materials and literature review findings for easy access and future reference.

Experience:

  • Bachelor’s degree in Life Sciences, Clinical Research, Healthcare, or a related field (Advanced degree preferred).
  • 2-4 years of experience in Clinical Research, Medical Affairs, Regulatory Affairs, or Medical Communications.
  • Experience preparing materials for Promotional Review Committees or similar review bodies.
  • Strong understanding of clinical trial processes, regulatory requirements, and promotional guidelines (e.g., FDA, EMA).
  • Demonstrated experience conducting literature reviews, including the ability to analyze,


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