Medical Writer (Regulatory)

Carrot Pharma recruitment; United States; Remote; USD 65,000 - 100,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Pension plan

Generous paid time off & sick leave

Tuition and fitness reimbursement

Employee assistance programme

Job summary

Carrot Life Sciences is partnering with a growing CRO to recruit a Medical Writer. This role blends clinical and regulatory writing with document quality control and publishing, supporting regulatory submissions.

You will interpret study results, prepare clinical documents and publications, review for accuracy, manage multiple projects and collaborate with cross-functional teams across pharma and device sectors.

Qualifications

• Advanced degree in Clinical, Medical or Life Sciences.
• At least two years of medical writing experience within a pharma clinical trial environment.
• GCP/ICH guidelines knowledge, including ICH E3 for clinical study reports.

Responsibilities

• Lead preparation of clinical documents and some scientific publications (CSRs, protocols).
• Interpret study results using protocols, SAPs and literature outputs.
• Review documents for scientific accuracy, data consistency and formatting.
• Coordinate review cycles, incorporate feedback and resolve quality issues.
• Support document publishing (PDFs, hyperlinks, bookmarks, pagination).
• Conduct literature searches and work with teams to meet deadlines.
• Support DMC activities including charters, meetings and minutes when required.

Skills

Detail oriented

Independent working

Strong communication

Education

Advanced degree in Clinical, Medical or Life Sciences

PhD or Master’s with relevant experience preferred

Tools

Microsoft Office

Adobe Acrobat

Job description

Job Title: Medical Writer

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

Package: $65,000-$100,000 base salary, plus benefits and performance-based bonus opportunity

Location: Remote anywhere in Canada, US or UK

Everything you need to know about the role:

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

This role combines clinical and regulatory writing with document quality control and publishing. You'll work closely with clinical project teams, interpreting study results and producing accurate, clear documents that support clinical development and regulatory submissions.

It's an opportunity for someone with medical writing experience who enjoys working with clinical data, takes pride in the detail and wants exposure to a varied range of projects.

You will:

• Lead the preparation of clinical documents and some scientific publications, including clinical study reports, protocols, to name a few.
• Interpret study results using protocols, statistical analysis plans, background literature and statistical outputs.
• Review documents for scientific accuracy, data consistency, referencing and formatting.
• Coordinate review cycles, incorporate feedback and resolve quality control findings.
• Support document publishing, including PDF preparation, hyperlinks, bookmarks and final pagination.
• Conduct literature searches and work with project teams to deliver documents within agreed timelines.
• Where required, support Data Monitoring Committee activities, including charters, meeting coordination and minutes.

Experience and qualities that make you a strong fit:

• An advanced degree in Clinical, Medical or Life Sciences.
• At least two years' medical writing experience within a pharmaceutical clinical trial environment.
• Knowledge of GCP and ICH guidelines, including ICH E3 for clinical study reports.
• The ability to interpret medical information and communicate study findings clearly.
• Strong attention to detail and a thorough approach to document quality.
• Confidence managing multiple projects, working independently and collaborating with colleagues and clients.
• Strong Microsoft Office and Adobe Acrobat skills.

Preferred:

• A PhD, or a Master's degree with substantial relevant subject matter experience.
• Experience writing clinical study reports for regulatory submission.
• Exposure to multiple therapeutic areas and Phase I-IV clinical trials.
• A good understanding of common clinical trial statistical analysis methods.
• Experience using the TRS Toolbox pharma edition plugin.

What's on offer:

• Base salary of $65,000-$100,000.
• Remote working within Canada, North America or the UK
• A performance-based bonus opportunity.
• Medical, dental and vision coverage.
• Life, accident and disability insurance.
• Pension plan, generous paid time off and sick leave.
• Tuition and fitness reimbursement, plus an employee assistance programme.
• The opportunity to develop your experience within an established CRO working across a range of clinical development programmes.

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. Carrot Life Sciences acts as an Employment Business and an Employment Agency on behalf of our client in recruitment for this role. 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.