About This Role
This role involves preparing scientific and regulatory documents for government and private sector clients, primarily for submission to the Food and Drug Administration (FDA). The Medical Writer will also perform literature searches, prepare reports, and contribute to technical proposals, while ensuring high-quality work products and compliance with clinical trial regulations.
Responsibilities
- Prepare scientific and regulatory documents for submission to the Food and Drug Administration (FDA) (Investigational New Drug applications, annual reports and development safety update reports, preclinical and clinical study reports, safety reports, protocols and protocol amendments, and investigator’s brochures, etc.)
- Perform literature searches and/or prepare summaries of results
- Prepare meeting reports and proceedings, safety documents or data analysis
- Contribute to technical proposals and respond to technical questions
- Develop and maintain quality control procedures to ensure processes are followed and timely and high-quality work products are delivered to clients
- Track progress on tasks and projects
- Maintain applicable templates for documents such as annual reports, New INDs, etc.
- Assist in evaluating existing processes and workflows to identify opportunities for digitization, automation, use of AI, and process optimization to ensure compliance with applicable clinical trial regulations, streamline efforts, and enhance quality
- Mentor and guide junior staff
Requirements
- Superior writing skills that require moderate to minimal editing (excellent English and grammar skills and demonstrated proficiency in scientific writing)
- Knowledge of regulatory requirements for clinical studies and a demonstrated interest in clinical research, medical writing, and/or regulatory affairs
- Ability to problem-solve and complete tasks with minimal oversight
- Strong software skills to include Microsoft Office products and reference management software
- Excellent time management, multi-tasking skills, attention to detail, and interpersonal skills
- Ability to analyze medical research data and review experimental protocols
Nice to have:
- Experience collaborating with IT or technical teams on digital transformation, workflow automation, AI, data analytics, or process-improvement initiatives
Important Details
- Work format: hybrid, 2 days in the Bethesda, Maryland office and 3 days working remotely
About the Company
TRI provides services to government and private sector clients.
