Senior Technical Writer

We are looking for a Senior Technical Writer (Fulltime, 40 hours a week) to join our Akkodis team working onsite of our client in the Leiden Area.

Start date: ASAP

Contract: 6 months contract

Job Responsibilities:

We are seeking a Senior Technical Writer to work at our client in the Leiden Bio Science Park, The Netherlands. In this role you will play a key role in ensuring high-quality, compliant, and scientifically sound documentation to support process and analytical development, validation, and regulatory readiness in a cell therapy environment.

Your mission

• Author and maintain key documentation for the Global MSAT and Viral Vector team, such as process descriptions, scientific reports, comparability protocols and reports, risk assessments, documents to support investigations, deviation management, SOPs, and regulatory submission content.
• Collaborate with cross-functional teams within and outside of the CMC organization (Manufacturing, PD, QC, AD, QA, RA,) as well as CRO and CDMO organizations, to gather, verify, and standardize technical content.
• Support regulatory submissions by contributing to and formatting CMC sections for INDs, IMPDs and responses to health authority questions.
• Ensure compliance with cGMP, GDP, and internal documentation standards.
• Manage document lifecycle in electronic systems, ensuring version control and timely updates.
• Promote documentation best practices, including template development, training, and continuous improvement of writing standards.

Company Details

We are Akkodis. We put the talents, skills and ambitions of our Consultants first. Because we continuously offer you challenging projects, you continue to develop and you can realize your ambitions. This is our view on good employment practices. We, Akkodis Life Sciences, offer you internal and external projects in the field of QA, QC, PV, RA, R&D, Supply Chain and related.

We have +/- 60 Consultants working at the EMA, Astellas, Unilever, Corbion, MSD, Organon, Aspen and many more! 

Candidate Profile

Job requirements:

• PhD degree in life sciences, biotechnology, engineering or related discipline with at least 7 years work experience or MSc with an equivalent level of experience
• Demonstrated experience with cell & gene therapy processes (e.g. CAR-T, viral vectors), GMP manufacturing, technology transfer, process validation and/or process development
• Proficiency in regulatory and technical/scientific writing for GMP environments
• Ability to translate complex technical/scientific concepts into structured, clear, and concise content
• Familiarity with document management systems (e.g. Veeva) and quality systems
• Excellent attention to detail, organization, and version control
• Strong communication and collaboration skills across diverse stakeholders

Are you interested in this challenge or do you want to come in touch?

Apply via your Talent Acquisition Specialist and/or send your CV to lifesciences@akkodisgroup.com.

Benefits

What do we offer:

• Employment for 40 hours per week and the opportunity to work at innovative and progressing companies. You will be part of a fast growing Life Sciences team that is represented in different industries (biotech, pharma, food) and present in Life Sciences clusters in The Netherlands; 
• Work-life balance with 24 to 36 holidays pro rata;
• Company fitness, health insurance and good pension scheme;
• Annual team events;
• Options to attend training, coaching and a personal development scheme;
• Career opportunities matching your aspirations and development.