Senior Medical Writer & Documentation Quality Lead

CTC Resourcing Solutions; Basel; On-site; CHF 110,000 - 170,000; Full time

Job summary

CTC Resourcing Solutions seeks a Medical Writer Documentation Specialist for a 2-year Basel-area contract. You will act as a subject matter expert ensuring clinical, nonclinical, and regulatory documents are accurate, compliant, and submission-ready across NDA, MAA, CSR, DSUR, and IND dossiers.

Required 7–10 years in clinical/nonclinical QA or regulatory writing, Master’s degree in a science field, Swiss permit, and fluent English. Basel area with extension potential.

Qualifications

• Swiss working/residency permit and/or Swiss/EU citizenship required.
• Master's degree or equivalent qualification required; science-related preferred.
• 7–10 years of experience in clinical/nonclinical QA, medical or regulatory writing, or editing.
• Strong knowledge of regulatory documentation requirements, guidelines, submission standards.
• Understanding of experimental methods, study design, and statistics.
• Ability to analyze clinical trial data and ensure accuracy.
• Fluent in English; additional European languages are an advantage.

Responsibilities

• Review clinical, regulatory and nonclinical documents for clarity, conciseness, consistency, completeness and compliance.
• Ensure documents are suitable for regulatory submissions (NDA/MAA/CSR/DSUR/IND).
• Collaborate with authors and cross-functional teams to improve document quality.
• Develop and implement documentation templates, guidelines, and best practices.
• Oversee external documentation quality specialists, allocate work and ensure timely delivery.
• Coach external consultants and teammates in documentation quality control.
• Support due diligence activities when required.

Skills

Regulatory writing

Quality assurance

Attention to detail

Communication skills

Education

Master's degree

Job description

CTC Resourcing Solutions seeks a Medical Writer Documentation Specialist for a 2-year Basel-area contract. You will act as a subject matter expert ensuring clinical, nonclinical, and regulatory documents are accurate, compliant, and submission-ready across NDA, MAA, CSR, DSUR, and IND dossiers.

Required 7–10 years in clinical/nonclinical QA or regulatory writing, Master’s degree in a science field, Swiss permit, and fluent English. Basel area with extension potential.