Job Title:Project Manager
Division - IPD
Department: PM
Job Purpose
The New Product Launch Project Manager in IPD (Integrated Product Development) function is responsible for leading and coordinating all cross-functional activities required to bring new products from late development phase through launch and into steadystate commercialization in USA market.
Scope:
The role ensures alignment among R&D,TT, Regulatory, Manufacturing / Supply Chain, Quality, Medical Affairs, QP, Market Access, Commercial, and other relevant functions to meet launch objectives (timelines, budget, quality, regulatory, market readiness).
Key Responsibilities
Launch Planning & Strategy
- Develop, maintain, and drive launch timelines, ensuring all functions (R&D, Quality, Regulatory, Supply, Commercial, Access) are aligned.
- prepare Approval and Launch plans (Gantt charts/Excel/MSP) with critical pathways and milestone activities
- Define launch readiness criteria; lead Launch Readiness Reviews
- Assist in Go/No-Go” decision points along the product launch lifecycle
Crossfunctional Coordination
- Act as single pointofaccountability for the launch project; manage crossfunctional teams
- Ensure regulatory, quality, and manufacturing requirements are met per country / region business goal
- Work closely with Global and Local/Regional teams to align strategies, resources, and deliverables
Risk & Issue Management
- Identify launch risks early; propose mitigation plans
- Track issues, escape when needed, ensure resolution to maintain timeline/budget
Forecasting & Supply Readiness
- Collaborate with Supply Chain / Manufacturing on capacity, inventories, firstorders
- Ensure packaging, artwork, labeling, and other logistical components are ready
Regulatory,,IP & Market Access
- Monitor regulatory submission status - coordinate regulatory/approval strategy
- Ensure market access, pricing, Agreements , QTA, Declarations ,Licenses requirements are considered in launch plan
- Understanding and driving of : review time FDAs queries , variation filings and timelines
Performance Tracking & Continuous Improvement
- Define metrics & KPIs for launch success (e.g. time to market, budget adherence, firstsales targets
- After launch, conduct postlaunch reviews, capture lessons learned
Stakeholder Engagement & Communication
- Regularly report to Senior Management / Steering Committees on launch status, risks, financials
- Ensure transparency among all internal stakeholders (Global, Regional, Local)
Budget & Resource Management
- Manage launch Trajectory for long term visibility by driving best case base case scenarios , NPL project budget; ensure resources (people, external vendors) are available and optimized
Required Qualifications & Skills
- Education: Bachelor’s degree in Life Sciences / Pharmacy / Chemistry / Engineering or equivalent; advanced degree (MSc / MBA / PhD) preferred
Experience
- Min 10 years of experience in pharmaceutical / biotech / life sciences industry, specifically in product development, product launches, or project management
- Experience working in IPD or similar integrated functions is a big plus
- Experience with regulatory submissions & approvals in USA
- Experience managing crossfunctional, matrixed teams (global, regional, local)
Core Skills
- Excellent organizational skills; ability to manage multiple concurrent launches
- Risk assessment and mitigation mindset
- Good communication skills: able to communicate up (senior leadership) and across functions
- Fluent English; local language skills beneficial depending on country coverage
- Commercial awareness (market access, reimbursement, competitive landscape)
Tools & Methods
- Familiarity with project management tools/software (e.g. MS Project, Planisware, JIRA, or equivalent etc
- Experience with forecasting tools / demand planning
- Experience with Regulatory / Quality systems and artwork / packaging process
Other Requirements
- Ability to travel intraEurope as needed (meet with stakeholders, supply sites, affiliates)
- Ability to adapt to shifting priorities & ambiguity-Agility Project management
Desirable Attributes
- Experience in rare diseases, biologics, or specialty medicines.
- Experience with digital tools / data analytics for decision support.
- Leadership influence without direct authority.
- High attention to detail, but also able to see big picture.
- Ability to learn and adapt quickly in fast moving regulatory or market environments.