Orca Bio

The Director of Scientific Communications will report to the Vice President of Medical Affairs. You will be responsible for strategic planning and execution of deliverables including MSL materials, training, congress coverage and scientific symposia at Orca Bio. Additionally, you will oversee the publications function, be a leader in the Medical Affairs department, and be an integral team member in preparation for a commercial launch.

The Manager, Regulatory CMC will be responsible for authoring and preparing regulatory packages in support of the chemistry, manufacturing, and controls (CMC) development for our early- to late-stage development pipeline products. The successful candidate will support the development and execution of regulatory strategies within Regulatory Affairs, working closely with CMC and Quality teams to ensure alignment with development milestones and regulatory compliance.

Support end-to-end contract lifecycle management (CLM) including intake, drafting, redlining, routing, execution, and archiving of a broad range of contracts. Implement and maintain contract management software, including configuration, user support, workflow development, and troubleshooting. Organize, maintain, and audit electronic and hard copy contract records to ensure compliance with internal policies and regulatory requirements.