Clinical Trial Education and Literature Review Specialist
Clinical Trial Education and Literature Review Specialist
Posted on :
20-10-2024
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Job Description
Santa Monica CA
Contract Duration: 736 months
Rate: Negotiable
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 detailoriented 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 crossfunctional 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 crossfunctional 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:
- Bachelors degree in Life Sciences Clinical Research Healthcare or a related field (Advanced degree preferred).
- 24 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
Employment Type
Full Time
Key Skills
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