Senior Medical Writer (Clinical Research)

Location: Remote within any location in Colombia.

Company

Award-winning, data-focused clinical research organization supporting pharmaceutical, biotech, and medical device companies with clinical trial data analysis and regulatory submission expertise.

What you will do

• Critically evaluate medical literature and select scientifically rigorous, unbiased source materials.
• Write and edit clinical protocols, investigator’s brochures, clinical study reports, consent forms, integrated safety and efficacy summaries, Module 2 documents, presentations, and publications.
• Manage writing timelines, workflows, assignments, and deliverables.
• Coordinate project requirements directly and independently with clients and internal stakeholders.
• Contribute to or manage interpretive guides and other regulatory writing projects.
• Mentor medical writers and project team members involved in the writing process.

Requirements

• At least 3 years of experience in the pharmaceutical industry.
• At least 3–5 years of regulatory writing and clinical medical writing experience.
• Bachelor’s, Master’s, or Ph.D. in a scientific, medical, or clinical discipline.
• Substantial clinical study protocol experience as a lead author.
• Experience leading teams or managing project teams while authoring regulatory documents under aggressive timelines.
• Exceptional writing, organizational, multitasking, and client communication skills, plus expert proficiency with Microsoft Word, Excel, PowerPoint, and related tools.

Nice to have

• Experience preparing clinical study reports for regulatory authorities.
• Knowledge of federal regulations, Good Clinical Practices, and ICH guidelines.
• Experience with orphan drug designations and PSP/PIPs.

Culture & Benefits

• Full-time employee position with a fully remote arrangement within Colombia.
• Supportive, collaborative, and inclusive work environment.
• Opportunity to work with pharmaceutical, biotech, and medical device clients across a global organization.
• Great Place to Work certified organization with a strong employee retention record.

Hiring process

• Applications are reviewed after submission.
• Candidates who are not contacted within 14 days should consider the application unsuccessful.