Senior Medical Writer

This is a fully remote position, open to applicants in United States.

📋 Description

• Prepare clinical study reports (CSRs), protocols, informed consent forms (ICFs), narratives, investigator brochures, and various regulatory documents across different therapeutic areas.

• Represent the Medical Writing team in meetings, lead document development, and effectively communicate strategies and timelines.

• Determine the appropriate stakeholders for content decisions and distill discussions into concise, precise prose.

• Evaluate the work of junior or outsourced writers as well as CSR-related documents such as Statistical Analysis Plans and TFLs.

• Create plain-language materials like ICFs and clarify complex medical concepts for non-specialist audiences.

• Comply with relevant guidelines, templates, SOPs, and internal training while actively contributing to process enhancements within Medical Writing and Global Development.

• Guide junior team members, balance multiple priorities, and promote teamwork to address conflicts.

⛳️ Requirements

• A Bachelor's degree is mandatory; an advanced degree is preferred.

• At least 3 years of experience in medical writing, with a solid understanding of biostatistics.

• In-depth knowledge of the clinical research process and relevant regulations, including ICH GCP.

• Experience in reading, writing, and editing clinical documents.

• Proficiency in MS Word, Adobe Acrobat, PowerPoint, and electronic document management systems.

• Capability to manage multiple projects with excellent organizational, interpersonal, and communication skills.

🏝️ Benefits

• Annual bonuses or other incentive plans.

• Equity awards.

• Pension or retirement benefits.

• 401(k) company match.

• Health and wellness programs.

• Access to fitness centers.

• Insurance benefits, including medical, dental, vision, life, and disability coverage.

• Paid time off.

• Family support benefits.