Medical Writer - I

Job Title: Medical Writer - I
Location: 100% Remote role, CA
Duration: 7 Months+ (Possible Extension)
 
Pay Range: $35.80/hr. on W2
 
Job Description:
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). This role is also 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.
Key Responsibilities:
• 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,