Project Management Associate

Job DescriptionJob DescriptionThe 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 strategiesEscalate critical risks to senior leadership and facilitate decision makingQualification ·

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 launchMicrosoft Office SuiteSkill Requirements ·

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 timelinesConflict resolution·

Excellent oral and written CommunicationCritical thinking and Problem-Solving AttitudeThis is an on-site role and there is no work from home option. The candidate has to work from Monday to Friday at our office location.