Job Overview 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 Qualifications & Requirements
Education:
Bachelor's degree in pharmacy, Chemistry, Biology, Biotechnology or a related life sciences discipline. An MBA or equivalent advanced technical degree is preferred.
Experience:
2+ years within pharmaceutical project management, operations, commercial launch
- Microsoft Office Suite 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 Pay:
$75,000.00 - $85,000.00 per year
Benefits:
401(k) 401(k) matching Dental insurance Health insurance Life insurance Paid time off Vision insurance
Work Location:
In person