Medical Writer / Medical Writeress

Medical Writer Documentation Specialist – 7103

Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, operates across multiple therapeutic areas and is committed to delivering products to the market within the next five years. They are seeking an experienced Medical Writer Documentation Specialist to serve as a subject matter expert on the quality of clinical, nonclinical, and regulatory documentation.

The successful candidate will ensure that key deliverables are clear, accurate, consistent, compliant, and submission-ready, thereby supporting development programs, health authority interactions, and global regulatory submissions.

This is a 2-year contract position based in the Basel area, with a high possibility of extension or transformation into a permanent role.

Main Responsibilities:

• Review clinical, regulatory, and nonclinical documents for clarity, conciseness, consistency, completeness, alignment with source data, and compliance with internal procedures, templates, ICH guidance, and relevant health authority requirements.
• Ensure documents are suitable for inclusion in critical regulatory submissions, including NDA, MAA, and IND dossiers.
• Partner with authors, contributors, and cross-functional stakeholders to continuously improve the quality of clinical and regulatory documents.
• Contribute to the development and implementation of documentation templates, guidelines, standards, and best practices.
• Manage collaboration with external documentation quality specialists, overseeing work allocation, quality control, and timely delivery of outputs.
• Coach and mentor external consultants and colleagues to develop expertise in documentation quality control.
• Support due diligence activities as required.

Qualifications and Experience:

• Relevant Swiss working/residency permit and/or Swiss/EU Citizenship required.
• Master’s degree or equivalent qualification required; a science-related discipline is preferred.
• At least 10 years of relevant experience in clinical and/or nonclinical quality assurance, medical or regulatory writing, or the editing and quality review of clinical and nonclinical documents.
• Strong knowledge of regulatory documentation requirements, guidelines, submission standards, and document quality expectations.
• Good understanding of experimental methods, research design, and statistical analysis.
• Ability to analyze and interpret medical data generated in clinical trials.
• Excellent attention to detail, accuracy, judgment, and quality orientation.
• Ability to work independently, manage priorities, and deliver effectively within tight timelines.
• Excellent communication and interpersonal skills, with confidence working across functions and with external partners.
• Fluency in English; additional European languages are an advantage.

Apply online using the form below. Only applications matching the job profile will be considered.