Project Management Associate

Published: 6/14/2022

Technology

Job Description

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

Qualification

· 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

Skill 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 timelines

Conflict resolution

· Excellent oral and written Communication

Critical thinking and Problem-Solving Attitude

This 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.