Pauwels Consulting
EN

Data Integrity Checker & Technical writer

Pharma & Sciences - Regulatory Affairs - Reference number (71215)

Are you passionate about making a difference and contributing to the pharmaceutical world ?  Are you detail oriented and want to have the opportunity to grow in the field? then this might be the job for you

  • Collaborate with Subject Matter Experts (SMEs) to produce comprehensive and compliant CMC documentation for new and existing products.
  • Manage the writing and review process, ensuring timely delivery of high-quality content to Regulatory Teams.
  • Coordinate effectively with various departments involved in documentation processes.
  • Monitor data integrity and identify potential improvements in writing and data-checking procedures.

What are we looking for?

  • Basic understanding of CMC disciplines spanning early-stage development to commercial products, including knowledge of GMP, Regulatory Affairs, and Quality requirements.
  • Previous experience in writing CMC technical documentation for (bio)pharmaceutical products.
  • Familiarity with ICH guidelines, as well as EMA/FDA regulations.
  • Excellent communication skills in both French and English, with the ability to effectively collaborate and networkes

What do we offer?

  • Challenging projects based on your interests and skills
  • Personal follow-up and clear, transparent communication both before and after commencement of employment
  • Possibility to follow extra training
  • Inspiring network events and legendary after work drinks
  • Strong network of industry leading clients
  • Expertise within IT, Engineering and Life Sciences
  • A flying start for every junior, growth opportunities and possibility to share gathered knowledge for more senior employees
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Naima Mait
Naima Mait
Talent Acquisition Specialist Life Sciences
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