Senior Medical Writer

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

Job Title: Senior Medical Writer

Type of company: Full-service Clinical Research Organisation (CRO)

Package: $90,000-$140,000 + benefits and performance-based bonus

Location: Remote within the US, or Canada. UK Candidates may also be considered.

Everything you need to know about the role:

We're working with a growing CRO supporting pharmaceutical, biotechnology and medical device companies to recruit a Senior Medical Writer.

You’ll lead clinical and regulatory writing projects from initial planning through to final delivery, working closely with sponsors and internal teams. This is an opportunity for an experienced writer who enjoys interpreting clinical data, producing high-quality documents and building strong client relationships.

You will:

• Author clinical and regulatory documents, including protocols, Clinical Study Reports, Investigator's Brochures, briefing packages, regulatory summaries and Development Safety Update Reports.
• Interpret study plans, clinical results and statistical outputs to produce clear, accurate scientific content.
• Manage writing projects from start to finish, coordinating review cycles, incorporating feedback and meeting agreed timelines.
• Act as the main medical writing contact for sponsors on assigned projects.
• Work with document publishing teams to ensure final deliverables meet submission requirements.
• Carry out peer reviews and quality checks, providing constructive feedback to other writers.
• Contribute to writing standards, SOPs and good working practices.

Experience and qualities that make you a strong fit:

• An advanced degree in clinical, medical or life sciences (MA or PhD)
• At least five years' medical writing experience, including work within the pharmaceutical clinical trial environment.
• Experience authoring clinical and regulatory documents.
• Knowledge of GCP and ICH guidelines, including ICH E3 requirements for Clinical Study Reports.
• The ability to interpret complex medical information and communicate it clearly.
• Strong organisation skills and confidence managing multiple projects and clients.
• A collaborative approach, attention to detail and the ability to work independently.
• Proficiency in Microsoft Office and Adobe Acrobat.

Preferred:

• Experience preparing documents for clinical trial authorisations and marketing authorisation applications.
• Experience across multiple therapeutic areas and Phase I-IV clinical trials.
• A strong understanding of clinical trial design and common statistical analysis methods.

What's on offer:

• Salary range of $90,000-$140,000.
• Opportunity to earn a performance-based bonus.
• Remote working within the US or Canada, or an office-based option in the Greater Toronto Area.
• Medical, dental and vision coverage.
• Life insurance and disability cover.
• Pension plan.
• Generous paid time off and sick leave.
• Tuition and fitness reimbursement.
• Employee assistance programme.

Unless otherwise stated, if applying for a job within the UK or European Union, you must ensure that you are already authorised to work there.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, colour, sex, age, national origin, religion, sexual orientation, gender identity and/or expression.

If there are any arrangements or adjustments we can make to assist you at interview then please let us know and we'll be more than happy to assist.