FSP Principal Medical Writer - Germany (m/f/d)

FSP Principal Medical Writer - Germany (m/f/d)

Work Schedule: Standard (Mon-Fri)

Environment: Office

Job Summary

We are expanding our Medical Writing FSP Team in Germany. This remote role will work from any location in Germany. The Principal Medical Writer will lead writing for a client in the FSP space, providing high‑quality medical and scientific documentation from planning and coordination through final drafts. The role includes reviewing documents, training junior writers, and advising on document strategy, regulations, and industry best practices.

Key Responsibilities

• Research, write, and edit clinical study reports, study protocols, and data summaries.
• Serve as primary author for complex clinical and scientific documents (IBs, INDs, MAAs) and provide senior level review of routine and complex documents.
• Provide training and mentorship for writers and program managers on document preparation, software use, regulatory requirements, and therapeutic area knowledge.
• Ensure compliance with quality processes and regulatory requirements; develop and review best practices and lead process improvement initiatives.
• Represent the department at project launch and review meetings.

Education & Experience

• Bachelor’s degree in a scientific discipline or equivalent; advanced degree preferred.
• 8+ years of relevant experience, including managing and directing complex medical writing projects.
• Experience in the pharmaceutical/CRO industry is preferred.
• Experience in Neurosciences is advantageous.
• Additional qualifications in medical writing (AMWA, EMWA, RAC) are advantageous.

Knowledge, Skills, and Abilities

• Significant knowledge of global and regional document development guidelines.
• In‑depth knowledge in one or more specialty areas such as preclinical, therapeutic, regulatory, submissions, or communications.
• Excellent data interpretation and medical writing skills, including grammar, editing, and proofreading.
• Excellent project management skills.
• Strong interpersonal, oral, and written communication and presentation skills.
• Excellent judgment and independence in decision making and problem solving.
• Ability to mentor and lead junior staff.

Benefits

Competitive salary and comprehensive benefits package focused on health and well‑being.