Clinical Trial Education and Literature Review Specialist
2 weeks ago
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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