Introduction

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.

Job Summary

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.