Senior Medical Writer - Regulatory & Study Reports

LS Jobbet AB; Uppsala kommun; Hybrid; SEK 520,000 - 760,000; Full time

Benefits offered by this job

Flexible working hours

Wellness allowance

Generous vacation terms

Job summary

CTC Clinical Trial Consultants AB in Uppsala is seeking an experienced Medical Writer to join a team responsible for writing and quality-checking regulatory documents, primarily clinical study protocols and reports, in line with ICH and ISO standards.

You will work within cross-functional project teams, coordinate development and quality control, and mentor colleagues while ensuring timely delivery of study results.

Qualifications

• Must have 3+ years of experience in medical writing, drug development, and clinical trials.
• Experience writing regulatory documents and eCTD modules.
• Excellent command of English; Swedish language knowledge beneficial.

Responsibilities

• Write clinical study protocols and clinical study reports in accordance with ICH E6, ICH E3, and ISO 14155, coordinating development and quality control.
• Write other regulatory texts such as summaries, amendments and responses to authorities.
• Coordinate and lead meetings with clients and project teams; act as a point of contact for clients.
• Mentor colleagues and support knowledge transfer within the MW team.

Skills

Medical Writing

Regulatory Documents

English Proficiency

Communication Skills

Project Coordination

Education

MSc Life Sciences

PhD Life Sciences

Tools

Microsoft Word

Job description

CTC Clinical Trial Consultants AB in Uppsala is seeking an experienced Medical Writer to join a team responsible for writing and quality-checking regulatory documents, primarily clinical study protocols and reports, in line with ICH and ISO standards.

You will work within cross-functional project teams, coordinate development and quality control, and mentor colleagues while ensuring timely delivery of study results.