Senior Medical Writer - Remote, Impactful Regulatory Docs

Carrot Pharma recruitment; May (TX); Remote; USD 90,000 - 140,000; Full time

Benefits offered by this job

Remote work within US/Canada

Health/dental/vision coverage

Life insurance

Disability cover

Pension plan

Generous paid time off

Job summary

Carrot Pharma recruitment is seeking a Senior Medical Writer to lead clinical and regulatory writing for a growing CRO. You will author protocols, CSRs, IBs, regulatory summaries and briefing packages, interpret data, and manage writing projects with sponsors and internal teams to meet timelines.

The role offers remote work within the US or Canada, with an office option in the Greater Toronto Area. Competitive salary $90,000-$140,000 plus benefits and a performance-based bonus.

Qualifications

• Advanced degree in clinical, medical or life sciences (MA or PhD).
• At least five years of medical writing experience in a pharmaceutical/clinical trial setting.
• Experience authoring clinical and regulatory documents.
• Knowledge of GCP and ICH guidelines, including ICH E3 for CSRs.
• Ability to interpret complex medical information and communicate clearly.
• Strong organisational skills and ability to manage multiple projects and clients.
• Collaborative, detail-oriented, and able to work independently.
• Proficiency in Microsoft Office and Adobe Acrobat.

Responsibilities

• Author clinical and regulatory documents (protocols, CSRs, IBs, briefing packages, regulatory summaries).
• Interpret study plans and results to produce clear scientific content.
• Manage writing projects from start to finish with reviews and timelines.
• Serve as main medical writing contact for sponsors on assigned projects.
• Coordinate with publishing teams to ensure submission-ready deliverables.
• Carry out peer reviews and provide constructive feedback.
• Contribute to writing standards, SOPs and best practices.

Skills

Medical writing

Regulatory writing

Project management

Communication

Attention to detail

Independence

Client coordination

Education

Advanced degree in clinical/medical or life sciences (MA or PhD)

Tools

Microsoft Office

Adobe Acrobat

Job description

Carrot Pharma recruitment is seeking a Senior Medical Writer to lead clinical and regulatory writing for a growing CRO. You will author protocols, CSRs, IBs, regulatory summaries and briefing packages, interpret data, and manage writing projects with sponsors and internal teams to meet timelines.

The role offers remote work within the US or Canada, with an office option in the Greater Toronto Area. Competitive salary $90,000-$140,000 plus benefits and a performance-based bonus.