Capgemini is a global leader in partnering with companies to transform and manage their business by harnessing the power of technology. The Group is guided everyday by its purpose of unleashing human energy through technology for an inclusive and sustainable future. It is a responsible and diverse organization of 270,000 team members in nearly 50 countries. With its strong 50 year heritage and deep industry expertise, Capgemini is trusted by its clients to address the entire breadth of their business needs, from strategy and design to operations, fueled by the fast evolving and innovative world of cloud, data, AI, connectivity, software, digital engineering and platforms. The Group reported in 2020 global revenues of €16 billion.
Get the Future You Want | www.capgemini.com
At Capgemini Engineering we value excellence, care, responsibility, dynamism and innovation. We offer a job with variation that leaves plenty of room for initiative and development. In fact, we are not just offering you a job, we’re inviting you to be part of our community where we will provide you trainings, tools & grounds for professional and personal growth. Each career experience is assorted by an attractive salary package.
If you are a team player, if you recognize yourself in this profile and are not afraid of taking on challenges… Apply today!
Regulatory affairs in the pharmaceutical sector is key to ensure product quality, accurate clinical trials and patient safety required to reach and maintain the Market Authorization. The CMC writer is in charge of the writing and edition of CMC documents to support registration of new products, as well as to ensure maintenance of registered dossier. Your main responsabilities are :
- Writing technical regulatory documents, as agreed with the business partners
- Writing Module 3 regulatory documents
- Writing Module 2 of regulatory files derived from completed eCTD
- Writing response to questions raised by regulatory authorities on CMC matters
- Liaising with SPOC to ensure adequate receipt of source documents
- Review technical documents prepared by other CMC writers to ensure quality meets defined standards
- Collaborate with SPOC and external partners to ensure the production and the review of CMC documents within agreed timelines
- Master degree in Life Sciences completed by a Regulatory Affairs degree/certificate and/or relevant experience
- Good scientific background to allow edition and review of technical registration files, to analyze and understand scientific and regulatory legislations
- Initial experience in technical CMC writing, preferably in the Pharmaceutical industry and vaccine-oriented (min 1 year, 2 years desirable)
- Knowledge of regulatory procedures
- Knowledge of EU/US variation legislation/guidance
- Organizational skills and effective time management
- Quality-oriented and attention to details
- Fluent in written and oral English. Good level of Dutch is a plus.