Remote Medical Writer: Regulatory Submissions & Reports

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

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.