Bachelor degree in a scientific, health, communications, technology health related field.Demonstrated experience in technical, regulatory scientific writing.
Within this program you will thrive within a fast-paced, dynamic study design. As we are fully embedded with this global pharmaceutical client, you will experience a true one team approach that provides limitless opportunity to develop through training, mentorship, and support from leadership.
Create and review regulatory documentation for Drug, Device and Combination product renewals and other life cycle maintenance-related submissions. Interact with non-regulatory support groups
Supports the day-to-day operations of the data management projects, providing in-house data entry support to projects and administrative support to CDMs, according to GCDMP guidelines, local regulatory requirements and Novotech, Client SOPs.
Ph.D. in relevant discipline and M.Pharm Pharmaceutical Quality Assurance, experience and good track record of publications, patents. The candidates who have submitted PhD thesis may also apply.
The individual has experience in handling various analytical techniques such as such as HPLC, GC, CE-SDS, SEC, ELISA, qPCR, DSC, Bioassay, Karl Fischer, UV, LC-MS, Dissolution, Disintegration, X-ray diffraction, etc.
Informing customers about the required documents for processing the customer orders. Sending reminders to the customer. Review and archive the documents from the customer.