jobid=A.0.0999
An international biopharmaceutical company is seeking an experienced Senior Technical Writer to support its cell and gene therapy initiatives—specifically focusing on CAR-T and Lentiviral Vector (LVV) programs. Based in Leiden, this position will work closely with the Global MSAT and Viral Vector teams to produce high-quality, regulatory-compliant documentation that supports process development, validation, and regulatory submissions.
Location: Leiden, Netherlands (Hybrid: 2–3 days onsite per week)
Start Date: ASAP
Contract: 6 months
Language Requirement: English
Key Responsibilities:
- Develop, review, and maintain a broad range of technical documents, including process descriptions, scientific reports, SOPs, risk assessments, comparability protocols, and deviation/investigation reports.
- Support the preparation of CMC sections for INDs, IMPDs, and regulatory responses.
- Collaborate cross-functionally with teams such as Manufacturing, QC, QA, RA, PD, and AD, as well as external partners (CROs, CDMOs), to gather and validate scientific content.
- Ensure all documentation aligns with cGMP, GDP, and internal quality standards.
- Manage document lifecycle through systems such as Veeva, maintaining strict control over versioning, review cycles, and approvals.
- Lead initiatives to improve documentation standards, including template creation, content quality training, and best practice implementation.
Candidate Profile:
- PhD or MSc in Life Sciences, Biotechnology, or Engineering.
- Minimum 7 years of experience in technical and regulatory writing within GMP environments.
- Background in cell and gene therapy required; direct experience with CAR-T or LVV is highly preferred.
- Strong ability to simplify complex scientific data into clear, accurate, and submission-ready content.
- Proficient in document management tools (e.g., Veeva) and well-versed in regulatory compliance practices.
- Meticulous attention to detail and consistency in content and formatting.
- Excellent communication skills and ability to engage effectively with multidisciplinary stakeholders.
Interview Process:
- First Round: Interviews with MSAT/Viral Vector and Regulatory team leads
- Second Round (if required): Interview with Quality or Technical Operations leadership
Interested? Apply below or send your CV to r.tartaglione@panda-int.com
