Medical Writer & Documentation Quality Lead

CTC Resourcing Solutions AG; Basel-Stadt; Vor Ort; CHF 110.000 - 150.000; Vollzeit

Zusammenfassung

CTC Resourcing Solutions AG in Basel area is seeking an experienced Medical Writer Documentation Specialist for a 2-year contract. You will ensure clinical, nonclinical, and regulatory documents are clear, accurate, compliant, and submission-ready to support global regulatory submissions.

The role requires a Master’s degree, at least 10 years in clinical/nonclinical QA, medical or regulatory writing, and fluency in English; Swiss work permit validity is essential.

Qualifikationen

• Master’s degree is required; science-related discipline preferred.
• At least 10 years of experience in clinical/nonclinical QA, medical or regulatory writing, or editing.
• Strong knowledge of regulatory documentation requirements, guidelines, and submission standards.
• Excellent attention to detail and ability to work independently under tight timelines.

Aufgaben

• Review clinical, regulatory and nonclinical documents for clarity, conciseness, consistency, completeness and compliance with procedures and ICH guidelines.
• Ensure documents are suitable for regulatory submissions (NDA, MAA, IND).
• Collaborate with authors and stakeholders to improve document quality.
• Contribute to templates, guidelines, standards and best practices in documentation quality control.
• Coordinate with external documentation quality specialists and oversee timely outputs.
• Coach and mentor external consultants and colleagues developing documentation quality expertise.

Kenntnisse

Medical writing

Quality assurance

Regulatory documentation

Documentation quality

Ausbildung

Master’s degree or equivalent

Jobbeschreibung

CTC Resourcing Solutions AG in Basel area is seeking an experienced Medical Writer Documentation Specialist for a 2-year contract. You will ensure clinical, nonclinical, and regulatory documents are clear, accurate, compliant, and submission-ready to support global regulatory submissions.

The role requires a Master’s degree, at least 10 years in clinical/nonclinical QA, medical or regulatory writing, and fluency in English; Swiss work permit validity is essential.