Jobs at Odin Pharmaceuticals

The Project Management Associate is responsible for coordinating end-to-end cross-functional activities from product development through regulatory approval, commercial readiness, and product launch for business development projects in-licensed from partners. This individual serves as a primary point of contact across internal and external stakeholders, ensuring that project milestones and deliverables are actively managed to support timely and successful commercialization.

Cross functional coordination:

• Research & Development: Coordinate product development program, ensuring alignment on scope, timelines, and project execution by working closely with partners.
• Regulatory Affairs: Coordinate and track regulatory submissions and approvals to support successful product registration and market authorization across internal and external stakeholders.
• Artwork & Labeling: Coordinate the development, review and approval of packaging artworks for filing and commercial launch.
• Serialization: Coordinate serialization connection between Somerset and partner. Once connection is established, coordinate with 3 PL team members to ensure everything meets DSCSA requirements.
• Quality: Coordinate quality agreements, documentation reviews, logistics (Case, Shipper, Pallet labels, before and after launch to ensure smooth batch release at launch.
• Sales & Commercial Readiness: Support commercial launch activities by coordinating Forecasts, purchase orders, product setup, documentation, production readiness, and cross-functional launch planning.
• Logistics & Supply Chain: Manage shipment planning and set up, shipping documentation, and product delivery to 3PL warehouse to ensure successful and timely product launches.

Launch Readiness:

• Project kick off and stakeholder alignment with internal and external parties
• Facilitate launch team meetings, prepare presentations and status reports, maintain meeting minutes and action items
• Maintain a launch readiness framework including Raw material/ packaging procurement, Manufacturing slot schedules, final release
• Identify gaps and implement mitigation strategies
• Escalate critical risks to senior leadership and facilitate decision making

Experience:

• 2+ years within pharmaceutical project management, operations, commercial launch

Qualifications and Skills:

• Highly organized and Self Motivated
• Ability to manage multiple workstreams, priorities, and deadlines simultaneously
• Strong follow-up skills with a demonstrated ability to drive action items to closure
• Proactive approach to identifying risks, gaps, and dependencies before they affect project timelines
• Excellent oral and written Communication
• Conflict resolution
• Critical thinking and Problem-Solving Attitude
• Microsoft Office Suite

Education:

• Bachelor’s degree in pharmacy, Chemistry, Biology, Biotechnology or a related life sciences discipline. An MBA or equivalent advanced technical degree is preferred.