Clinical Research Specialist
hace 3 semanas
Lancesoft is seeking an experienced Clinical Literature Review Specialist to support the development and submission of clinical trial education materials to regulatory review committees. This role involves conducting comprehensive literature reviews to assess the landscape of new and emerging medical indications.
Key Responsibilities:
- Develop, organize, and submit clinical trial education materials to regulatory review committees for review and approval, ensuring compliance with regulatory and company guidelines.
- 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.
- Assist in the development of communication strategies that effectively educate healthcare professionals about clinical trials, investigational products, and new medical indications.
- Maintain a comprehensive database of clinical trial education materials and literature review findings for easy access and future reference.
Requirements:
- 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.
- Strong understanding of clinical trial processes, regulatory requirements, and promotional guidelines (e.g., FDA, EMA).
About Lancesoft:
Lancesoft is a leading provider of clinical trial education and literature review services. Our team of experts is dedicated to supporting the development and submission of clinical trial education materials to regulatory review committees. We are committed to delivering high-quality services that meet the needs of our clients.
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