- The IMPD writer is responsible for managing the redaction process of quality IMP documentation intended to be used in clinical trial applications.
- He/she is part of the CMC development group and is working in close collaboration with the Regulatory department.
- Coordinate and prepare quality IMP documentation (Module 3, quality IMPD) in close collaboration with CMC development Leads (drug substance, analytical, drug product). Issue IMP documentation based on CMC source development reports, organize internal reviews and finalize the documents intended to filed through CTA.
- Coordinate and prepare CMC regulatory dossiers and briefing packages for scientific advise meetings
- Coordinate and prepare answers to CMC/quality questions obtained from Competent Authorities
- Keep track of changes in regulatory requirements with regards to quality and related guidelines and implement these changes in quality IMP documentation.
- Advise the CMC teams on regulatory CMC strategy.
- Develop and maintain procedural documents for the assigned responsibilities
- University degree in health sciences, pharmacy, biological science, chemistry or related field.
- At least 5 years of relevant experience in CMC development or IMPD writing in a range of projects
- Knowledge and understanding of CMC development
- Knowledge and understanding of regulatory requirements and related guidelines
- Demonstrated attitude of reliability and attention to detail.
- Strong organization skills, a high degree of flexibility, resilience, and assertiveness are essential for success.
- Professional attitude towards external and internal contacts.
- Data gathering, problem solving and analytical thinking skills are highly desirable.
- Communication Skills
- Strong verbal and written communicator in English language, multilingual is an asset