Temporary onsite consultant for the regulatory review and coordination of Phase 3 Clinical Trials.
Global pharmaceutical company.
- Assist with core Clinical Trial Application package review
- Responsible to ensure harmonization of worldwide local CTA packages with the validated core CTA package
- For national specific forms and information: perform a critical analysis prior to reviewing the document with Regulatory Affairs Project Manager in charge
- Ensure adherence to Good Clinical Practice and all applicable local and international regulations
- Responsible to archive submitted dossiers, communication received from the authorities (queries, letter of approval"¦)
- Responsible to maintain and create tracking tools, enabling all departments in the strategical decision-making process
- Upon requests, perform review of CTA major amendment to ensure timely submissions
- Keeps informed about key regulatory trends and change in regulation regarding CTAs
- Hands on experience of Clinical Trial preparation and submission in Europe and Rest of the World countries
- Solid knowledge of GXP regulations
- Past experience in working with a CRO
- Experience with MS Office products and database applications required.
To be discussed.