Medical Writer Documentation Specialist

CTC; Basel; On-site; CHF 120,000 - 160,000; Full time

Job summary

CTC in Basel seeks an experienced Clinical/Regulatory Quality Assurance professional to lead and optimize the quality of regulatory documents for NDA/MAA/IND submissions. You will collaborate with authors and cross-functional teams to drive excellence in documentation and templates.

The role requires a Master’s degree (science-related preferred) and 10+ years in QA, medical or regulatory writing, and document quality review, with fluency in English and additional European languages as an

Qualifications

• Master’s degree (or equivalent) and science-related discipline preferred.
• At least 10 years of experience in clinical and/or nonclinical QA, medical or regulatory writing, or editing/quality review of 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 from clinical trials.
• Fluency in English; additional European languages advantageous.

Responsibilities

• Review clinical, regulatory, and nonclinical documents for clarity, conciseness, consistency, completeness, alignment with source data, and compliance with internal procedures and ICH guidance and health authority requirements.
• Ensure documents are suitable for inclusion in regulatory submissions (NDA, MAA, IND).
• Partner with authors, contributors, and cross-functional stakeholders to 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, including work allocation, quality oversight, and timely delivery of outputs.
• Coach and mentor external consultants and colleagues developing expertise in documentation quality control.
• Support due diligence activities when required.

Skills

Quality assurance

Regulatory writing

Editing & quality review

Detail-oriented

Communication

Education

Master’s degree or equivalent

Science-related discipline preferred

Job description

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, including work allocation, quality oversight, and timely delivery of outputs.
• Coach and mentor external consultants and colleagues developing expertise in documentation quality control.
• Support due diligence activities when 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 analyse and interpret medical data generated in clinical trials.
• Excellent attention to detail, accuracy, judgement, 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 an advantage