Job Description
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
- Broad and in-depth expertise in medical and scientific writing, particularly in clinical research documentation.
- Understanding of clinical research processes, drug development, and regulatory guidelines.
- Excellent written and verbal communication skills with the ability to translate complex scientific concepts into clear and concise documents.
- Strong organizational skills, with keen attention to detail and the ability to manage multiple tasks efficiently.
- Experience in managing multiple content and studies at different stages.
- Proficiency in using document management systems and Microsoft Office Suite (Word, Excel, PowerPoint).
- Ability to work independently and collaboratively in a cross-functional team environment.
- Knowledge of molecular imaging, radiopharmaceuticals, and translational research is preferred.
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.
- Collaboration with cross-functional teams
- 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.
- Standardization & Process Improvement
- Develop and maintain document templates and reusable content to improve efficiency and consistency across projects.
- Document Management
- 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.
- Ensure accuracy and consistency in all written materials.
- Review and edit content for clarity, grammar, and technical accuracy.
- Process Documentation
- 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
Job Tags
Contract work, Part time,