Senior Medical Writer

Since 1990, METRONOMIA has stood for quality, competence, continuity and unconditional customer orientation in terms of data management, statistical services and medical writing in clinical research. As a growth-oriented medium-sized company with over 150 employees, we operate internationally. Our customers appreciate the competence and commitment of our employees and we value our employees as the basis of the company's success. Join a motivated and friendly team as

• Plan, author, and finalize clinical and regulatory documents, including clinical study protocols and amendments, investigator’s brochures and updates, clinical study reports, development/periodic safety update reports, risk‑based safety narratives, and clinical/summary modules for global submissions.
• Translate statistical outputs into clear, compliant narratives and summaries aligned with SAPs and ICH guidance.
• Drive document quality control and proofreading to submission-ready standards.
• Coordinate, collect, and compile source materials from cross‑functional trial teams for CSR appendices and eCTD components.
• Manage timelines, reviews, and comment reconciliation across Clinical, Biostatistics, Pharmacovigilance, Regulatory, and Data Management.
• Degree in life sciences, public health, or related field with strong understanding of drug development and clinical trials.
• Proven track record delivering submission-grade regulatory documents (e.g., CSRs, protocols, IBs, DSURs, Module 2 clinical summaries, submission dossiers) within clinical development environments.
• Mastery of relevant ICH and regional guidance; adherence to SOPs and templates.
• Excellent written and oral English; meticulous attention to detail and data integrity.
• Effective time management and the ability to work independently and in cross‑functional teams; accountable for deliverables and timelines.
• Clear, solution‑oriented communicator with sound judgment on when to elevate issues.

• Appreciation and family-friendliness: hybrid working models and a culture that values you as a person.
• Excellence is worth it: attractive remuneration and comprehensive company benefits.
• Flat hierarchy: we collaborate at eye level to foster a motivated, high‑quality team environment.
• Challenging tasks: thorough onboarding and regular opportunities for internal and external training.

Please send us your CV or your Linked In profile and a short cover letter including details of your possible start date and salary expectations. If you have any questions about the position and the application process, please do not hesitate to contact our HR Manager Christoph Hortian (/ ).