CMC Project Manager M/F -CDD- H/F
Core
Coordinate CMC subteam activities and documentation for clinical submissions from Phase 1 to registration for new biological or chemical drug candidates.
Role type
CMC Project Manager
Builds
Clinical development programs for pharmaceutical candidates
Domain
Pharmaceutical R&D / CMC / Clinical Development
Deliverable
client delivery
Required skills
CMC project management, clinical study planning (Phase 1-3), cGMP knowledge, CDMO/partner management, budget management, meeting coordination, regulatory documentation preparation
Preferred skills
Technical leadership in project management, experience with formulation/process changes and scale-up
Technologies
None stated
Responsibilities
Coordinate CMC subteam activities with respect of timelines; Organize internal CMC team meetings and partner meetings; Plan CMC activities and manage budget; Support CMC Subteam Leader in tasks; Prepare and coordinate governance meetings and slides; Coordinate preparation and update of CMC documentation for clinical submissions (IND/IMPD, amendments, Module 3)
Seniority
Mid-Senior, hands-on IC
