Project overview:
Minimize time between clinical cut off date (CCOD) / LPLV to marketing authorization of pivotal studies through accelerated filing and HA interactions in a sustainable way (without increasing resources), and at the optimal quality to meet regulators' needs.
Streamlining other submission types that are not part of a major filing (e.g, US INDs, CTAs, International filings as prioritised by pharma strategy).
Responsibilities and requirements for the position:
Required technologies and skills: AWS, Databases, SQL, Python (must)
Job Types: Full-time, Contract
Contract length: 12 months