Job Title: Medical Writer (part time) Location: Northeast (EST) candidates preferred Hours: 30 hours/month (7-8 hours/week) Type: Contract (C2C or W2) Job Purpose The Translational Research Medical Writer plays a key role in the development and finalization of clinical research documents, supporting the creation of Informed Consent Forms (ICFs), clinical protocols, and imaging study reports (ISRs) for early phase molecular imaging studies. Additionally, if qualified, the writer will support FDA Investigational New Drug (IND) document development (Module 2). The role ensures document quality, consistency, and regulatory compliance while collaborating closely with internal and external cross-functional clinical research teams (Chemistry, Clinical, Quality Assurance, Project Management, Regulatory, Image Analysts, Scientists, Investigators, Operations, Medical Monitors, etc.) Requirements Bachelor’s degree in Life Sciences, Health Sciences, or related field required. Master’s degree preferred. Minimum 3 years of experience writing scientific, medical, or technical content, preferably in a clinical research setting. Experience with clinical protocol development, ICF development, and ISR development preferred. Experience in managing multiple content and studies at different stages. Knowledge of medical terminologies and jargon. Demonstrated understanding of clinical research, drug development processes, and regulatory requirements (e.g., FDA, EMA). Strong grasp of Standard Operating Procedures (SOPs) and regulatory writing best practices. Experience in molecular imaging (PET, SPECT, MRI) is a plus. English: Fluent Key Responsibilities Development of study-specific documents Draft, edit, and finalize high-quality ICFs, clinical protocols, and ISRs Assist in the preparation of FDA IND Module 2 content, ensuring alignment with regulatory standards. Translate complex scientific data into clear, user-friendly information. Work closely with internal teams (Chemistry, Project Management, Regulatory, etc.) and external stakeholders to ensure consistency and accuracy in document development. Collaborate with medical experts and researchers to gather information. Develop and maintain document templates and reusable content to improve efficiency and consistency across projects. Oversee and coordinate document development for assigned projects, ensuring timely completion and compliance with client and regulatory requirements. Ensure all documents meet applicable regulatory guidelines and company quality standards and are appropriately stored and organized. Review and edit content for clarity, grammar, and technical accuracy. Contribute to the creation, documentation, and implementation of medical writing processes to enhance efficiency and best practices. Benefits: System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan. Ref: #568-Clinical #J-18808-Ljbffr System One
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