- 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.
- 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.
- 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