You are a highly skilled professional with passion for the world of Life Sciences and Clinical Research? You want to thrive in a dynamic and collaborative international environment where your expertise directly impacts people lives? ​

Come and join Aixial Group to contribute to shaping the future of clinical research!​

We are currently hiring a CMC Technical Writer – Data Checker M/F to focus on the overall CMC Product Knowledge Management for designated products. The position is based on the Walloon region, in Belgium.

Your main responsabilities are (non-exhaustive list):

• To be involve in the internal CMC documentation related to new and existing (bio)pharmaceuticals products.
• To be focus on CMC Data & documentation supporting major and minor submissions.
• Manage and schedule the writing/review process with Subject Matter Experts (SMEs) to deliver adequate (content & format) information to Regulatory Teams.
• Ensure good coordination with departments involved in the writing/review process.
• Monitor that supportive data used in the CMC documentation are compliant, report significant issues and identify and resolve inconsistencies in data.
• Identify space of improvements in the process of writing & data checking and propose potential solutions.

Skills and Knowledge required:

• University level (Life Sciences background) or equivalent by experience.
• Basic understanding of all disciplines related to CMC from early-stage development to commercial products. Understand GMP, Regulatory Affairs and Quality requirement.
• Basic experience in writing CMC (technical) documentation for (bio)pharmaceuticals products
• Knowledge of ICH guidelines, EMA/FDA guidelines
• Good communication, writing, analytical, and critical thinking skills.
• Ensures coherence between contributions and quality of final results.
• IT tools learning facility

Languages skills required:

• Good level in French and English (spoken and written) would be required

Who Are we? ​

• We are one of the world’s leaders in CRO (Contract Research Organisation) with the commitment, expertise, and flexibility needed to deliver efficient clinical trials. ​

• We work with global pharmaceutical, biotech, cosmetic, medical device, and many other companies around the globe, providing them with innovative and scalable solutions.​

• We are operating in 10 countries across 3 continents, bringing together over 1000 talented professionals dedicated to make a positive impact in the life sciences industry. ​

• We have been part of ALTEN Group since 2014 and are continuously exploring new opportunities to expand our activity worldwide. ​

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Why Join Us?​

• Make a positive impact and be at the forefront of project:  ​

  You will be part of groundbreaking advancement in clinical research that has positive impacts on millions of people’s lives globally. ​

• Career Development: ​

  People are our biggest asset. We are committed to empower our team continually and build a positive and supportive environment that fosters growth, flexibility, and teamwork. At Aixial Group, you will be coached and mentored throughout your journey to help you advance your professional and personal growth.​

• Our commitment to Diversity, Equality, and Inclusion: ​

 We aim to create a workforce which promotes dignity and respect, where individual differences are recognized and valued, and where each employee can give their best. ​

Gender equality is at the core of the development strategy of Aixial Group. ​

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Aixial Group continues to grow, and to recruit in the clinical trial professions. Join us, and discover our website to follow the news of our offers: https://www.aixialgroup.com/join-us/​

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For more information: https://www.linkedin.com/company/aixialgroup/about/​