Regulatory CMC Contractor

Hours per Week : 10-20 hours/week, for approximately 3-4 months

Location : Remote (on-site hybrid preferred)

Skills and Responsibilities :

• Technical Writing : Assist in drafting technical documents with guidance provided.
• Collaboration : Work under supervision to execute documents while the lead provides clinical insights and reviews the work.
• Documentation : Focus on authoring M3 section for a Phase 1 IND (Initial IND for the project).
• Expertise : Prior experience in Cell Therapy and CMC (Chemistry, Manufacturing, and Controls).
• Support : Share the workload, particularly for IND and Master File preparation, covering multiple jurisdictions.