Medical Writer

This is a fully remote position, open to applicants in Costa Rica.

📋 Description

• Evaluate study protocols and contracts for inclusion/exclusion criteria, imaging objectives, endpoints, and indication-specific requirements.

• Assess study-specific electronic Case Report Forms (eCRFs/CRFs) for precision and consistency with protocol requirements.

• Create, write, and finalize study documentation, including Site Manuals, Quick Reference Guides, Charters, and other study-related documents or forms as needed.

• Review, revise, and support Standard Operating Procedures (SOPs) pertaining to Medical Communications.

• Oversee the document development lifecycle, which includes version control, tracking databases, and maintaining templates.

• Offer guidance to project teams to ensure the timely delivery of final, approved documentation.

• Engage in internal and external meetings concerning study documentation and deliverables.

• Confirm that all documentation adheres to quality, regulatory, and internal compliance standards.

• Keep accurate and organized documentation records in line with company policies.

⛳️ Requirements

• Bachelor’s degree in Life or Physical Sciences (e.g., Biology, Chemistry, Pharmaceutics).

• A minimum of 2 years of medical writing experience is preferred.

• At least 3 years of experience in pharmaceutical, clinical, or imaging research environments is required.

• Expertise in medical, regulatory, and clinical writing.

• Strong understanding of clinical trial terminology and documentation standards.

• Proficiency with Microsoft Office Suite.

• Exceptional attention to detail, documentation, and organizational skills.

• Strong written and verbal communication as well as interpersonal skills.

• Capability to manage multiple projects, prioritize efficiently, and adjust to changing timelines.

• Ability to engage in prolonged computer-based work.

• Minimal travel is required (approximately 0–5%).

🏝️ Benefits

• Competitive compensation.

• Comprehensive health and wellness benefits.

• Flexible work arrangements.

• Paid time off and company holidays.

• Engaging employee programs and professional development opportunities.