Job Title: Medical Writer/ Clinical Trial Education and Literature Review Specialist
Location: Remote
Duration: 07 months contract with a possibility of extension
Shift Details: First shift
Pay Range: Negotiable
Job Description
- 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.
Qualifications
- 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.
