Principal Medical Writer (Regulatory focus) - Sponsor-dedicated - Poland, Belgium, Netherlands,[...]

Principal Medical Writer – Regulatory Focus (Sponsor‑dedicated)

Location: Poland, Belgium, Netherlands, Spain

Job Summary

The Principal Medical Writer I is responsible for developing clinical documents for global regulatory submissions. The role provides strategic direction to cross‑functional teams, ensures timely delivery of high‑quality documents, and serves as lead writer for summary documents across multiple compounds.

Responsibilities

• Develop regulatory documents for submission to global authorities in accordance with ICH and other guidelines.
• Manage medical writing projects, develop timelines, and coordinate with study/project teams.
• Participate in cross‑functional meetings to provide input on deliverables, timelines, and processes.
• Review related documents such as Protocols and Statistical Analysis Plans as appropriate.
• Develop and implement process improvements, standard operating procedures, and best practices.
• Manage internal and contract medical writing resources to meet project deadlines.
• Mentor and coach junior medical writers.

Qualifications

• Bachelor’s degree required; advanced degree in a relevant scientific/clinical/regulatory field preferred.
• At least 5 years of medical writing experience in the biopharmaceutical/CRO industry or comparable clinical development experience.
• Proficiency in organizing and communicating clinical information with minimal oversight.
• Strong organizational, time‑management, and project‑management skills.
• Excellent verbal, written, and interpersonal communication skills.
• In‑depth understanding of global regulatory requirements and therapeutic areas across clinical development phases.
• Proficient in MSWord and electronic document management systems with template usage.

EEO and Accessibility Statement

The Company is committed to compliance with the Americans with Disabilities Act and will provide reasonable accommodations as appropriate to assist employees or applicants in performing essential job functions.