Clinical Dossier Lead Consultant

vor 19 Stunden


Basel, Schweiz headcount AG Vollzeit

**Clinical Dossier Lead Consultant**

**Location**: Basel
**Contract**: 6-month, with potential for extension
**Start Date**: ASAP
**Workload**: Full-time
**Overview**:
Our client, a Swiss pharmaceutical company specializing in medicines for rare diseases, is seeking an experienced Clinical Dossier Lead Consultant. This role involves leading the update and submission of major regulatory dossiers.

**Key Responsibilities**:

- Lead the update of major regulatory dossiers.
- Extract, interpret, and integrate clinical data from several study reports, ensuring consistency and accuracy.
- Collaborate with and provide direction to medical writers for summary of safety, clinical overview, and other key documentation.
- Evaluate long-term safety data for an already submitted dossier and incorporate findings into updated submissions.
- Act as the lead for clinical submissions, ensuring compliance with regulatory standards for NDA and MAA filings.
- Address challenges in the existing dossier structure and improve document quality for clarity and coherence.
- Partner with internal and external teams to align on submission strategies and timelines.

**Required Qualifications**:

- Advanced degree in life sciences, medicine, or a related field.
- Extensive experience (8+ years) in regulatory affairs, clinical science, or related roles, with a focus on dossier preparation and submissions.
- Proven track record of leading NDA and MAA submissions in the pharmaceutical/biotech industry.
- Ability to navigate and improve poorly structured dossiers with a critical, problem-solving mindset.
- Strong analytical, data interpretation, and regulatory writing skills.
- Excellent communication and leadership skills, with experience guiding cross-functional teams.

headcount AG



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