For one of our clients in Mariakerke, we are currently looking for a "CMC Writer API ( Drug Substance Development )".
Job Description
Our client is a fully integrated Contract Development & Manufacturing Organization (CDMO) with a core focus on bringing molecules to the clinics.
Responsibilities
- Authoring scientifically sound source documents related to drug substance activities (such as synthesis criticality analysis reports, starting material justification reports, impurity management reports, etc.) which may be used as basis for global regulatory submissions (IMPD, MAA, NDA)
- Establishing the control strategy for the drug substance manufacturing (specifications)
- Nitrosamine and mutagenicity assessments per ICH M7
- Alignment of the documents to ensure compliance with the latest ICH guidelines
- Project management/coordination of technical writing and reviewing activities
- Ensure that the documentation is of high quality and that potential issues are discussed with our customers
Do the above responsibilities fit you like a glove?
Upload your CV and motivation letter via the "apply now" button and you can expect feedback from us soon.
If something is not entirely clear, you can reach out to us by telephone of course.
Requirements
- Master's degree or Ph. D. in a scientific discipline e.g., chemistry, pharmacy, biotechnology or similar. Affinity with organic chemistry and drug substance development is required.
- Working experience with scientific and/or technical writing is a plus.
- Basic knowledge and understanding of regulatory guidelines, manufacturing processes, analytical methods (HPLC, GC, …), specifications, method validation, process validation
- Excellent writing and communication skills
- Very good knowledge of English is required
- Proficiency with MS Office (mainly Word, Excel)
- Good planning and organizational skills with demonstrated ability to deliver work on-time
- Customer-oriented and quality conscious attitude
- Eye for detail
- Accurate
- Critical mind
- Problem-solver
- You have a proactive attitude, and you dare to think out-of-the box
- Ability to find information in regulatory guidelines and literature search
- Ability to work in a team and independently
- Eager to learn
Benefits
- An attractive and tailor-made remuneration package including extra-legal benefits, like meal vouchers, insurance, etc ..
- Ability to grow your skills in a rapidly growing company with international customer portfolio
- A dynamic working environment
- Day shift system
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy Number: 16677
