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CMC Technical Writer Ghent Belgium,  

Ablynx (company)


Posted on : 11 June 2017

Project Description

Description:
  • Our company  is looking for a highly motivated CMC Technical Writer to strengthen the team. 
  • The successful candidate is expected to be responsible for the preparation, writing and editing of high quality CMC-documents, based on draft technical sections from CMC experts. High quality refers to scientific content, organization, clarity, accuracy, consistency, format, and adherence to regulatory and internal guidelines, styles and processes.

 

Key responsibilities
  • Responsible for the preparation, writing and editing of technical CMC documents (e.g. process development protocols/reports, validation protocols/reports, characterization reports, CMC sections of regulatory documents, etc.) with minimal guidance. 
  • Ensure that the finished document is complete and accurate and complies with the approved format. 
 


Profile
  • Expected educational qualifications: University degree in life-sciences (Biology, Biotechnology, (Bio)Chemistry, Pharmaceutics, Biomedical Sciences, Bio-engineering) 
  • PhD and/or track record of scientific publications is a plus 
  • Excellent technical writing skills in English 
  • Strong skills in document management and management of review/approval cycles 
  • Relevant experience in one or more of the CMC/biopharmaceutical development activities (e.g. upstream & downstream process development, analytics, formulation, GMP manufacturing, comparability/compatibility/stability studies, process validation, design control, &) is a must 
  • Previous experience in regulatory writing and in preparation of regulatory documentation (e.g. Module 3 MAA/BLA) is a plus 
  • Fluency in Windows and Microsoft Office (Word, Excel, Access, Power Point, Outlook) 
  • Experience with Adobe Acrobat is a plus 
  • Knowledge of biopharmaceutical regulations desirable 
  • Have a sense for initiative, quality, accuracy and detail 
  • Ability to work independently, with minimal supervision 
  • Be stress-resistant and able to deal with significant responsibilities and deadlines 
  • Excellent collaboration skills (both with internal and external parties), with focus on quality and timely delivery 
  • Be a team player, enthusiastic and flexible, eager to learn 

Locations

Ghent Belgium

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