Remote Medical Writer — Regulatory & Scientific Reports

Criterion Edge Professional Services Inc.; United States; Remote; USD 10,000 - 21,000; Part time

Job summary

Criterion Edge is seeking a remote Medical Writer to join our best-in-class writing team and help take our regulatory and scientific deliverables to new heights. You will produce a wide variety of reports, plans, and other documents for medical device, pharma/biotech, and in vitro device clients, collaborating with writers, project managers, and support staff.

This role emphasizes accuracy and regulatory alignment.

Qualifications

• 2+ years of direct writing experience in pharmaceutical, medical device, in vitro device or related academic fields.
• Minimum of a BSc in a life sciences or related discipline / related field.
• Advanced word processing skills, including Microsoft Office, Adobe Acrobat, Excel and SharePoint.
• Familiar with current guidelines and regulations governing the project.
• Knowledge of systematic literature review (SLR) methodology and best practices.
• High level of English fluency with strong oral and written communication.

Responsibilities

• Direct responsibility for writing documents or document sections on assigned projects.
• Organize workload, identify project needs and meet timelines.
• Meet client expectations through teamwork and adherence to deadlines.
• Collaborate effectively with other project writing team members.
• Document tasks, time estimates and due dates into the project plan and provide progress updates.
• Ensure data presented is clear, complete, accurate, and concise with consistent conclusions.
• Incorporate expert feedback and adjust content accordingly.
• Stay current with medical writing best practices and regulatory knowledge.
• Identify risks and discuss solutions with the project team.
• Participate in QC checks for accuracy following internal processes.
• Provide feedback to junior staff and mentors when appropriate.
• Establish professional relationships with colleagues and clients.
• Demonstrate initiative and seek clarity when faced with unfamiliar requirements.

Skills

Medical writing experience

English communication

Regulatory guidelines knowledge

Independent work

Education

BSc in Life Sciences

Tools

Microsoft Word

Adobe Acrobat

Excel

SharePoint

Job description

Criterion Edge is seeking a remote Medical Writer to join our best-in-class writing team and help take our regulatory and scientific deliverables to new heights. You will produce a wide variety of reports, plans, and other documents for medical device, pharma/biotech, and in vitro device clients, collaborating with writers, project managers, and support staff.

This role emphasizes accuracy and regulatory alignment.