Technical Project Manager CP Development support (Phase 1b/2a)

Responsibilities:Responsibilities:

• Support an early-stage pharmaceutical development project with focus on CP Development Support
• Coordinate and support activities related to the Device Constituent Part within a Combination Product
• Support preparation activities for clinical Phase 1b / 2a from a CP and device development perspective
• Contribute to technical roadmaps, development strategies and relevant CP / device documentation, including DDF / Device Development File
• Coordinate cross-functional workstreams between Pharma Development, Quality, Regulatory, CMC and Device Development teams
• Support Quality and QMS-related topics, including QMS Gap Assessment
• Contribute to Pre-IND / IND-related activities with focus on CP and Device-related aspects

Qualifications:

• Experience in the pharmaceutical industry, ideally within early clinical development
• Experience with Combination Products, ideally involving Drug Delivery Devices, Medical Devices or Device Constituent Parts
• Solid understanding of CP Development Support and the interface between drug product and device development