Sr. Project Manager - Drug Product , Pharma , CDMO

Responsibilities

• Develops and tracks the project development plan using Smartsheet.
• Identifies and tracks critical path/activities, risks, contingencies and alternatives.
• Communicates out-of-scope activities both internally and externally.
• Implements Change Orders.
• Facilitates team meetings with client and project team; setting-up sub-team meetings as necessary.
• Drives strong interdepartmental collaborations to drive task completion and maintain project timelines.
• Develop a strategy and work with project teams and clients to manage their contract needs.
• Develop and approve proposals and contracts for assigned clients and projects in conjunction with the appropriate project team members.
• Manage contract requirements for each assigned project through ERP and project teams.
• Communicate budget requirements and status to all team members for each assigned project.
• Design, implement timelines, and coordinate a detailed project operational plan for each assigned project.
• Provide project status information both internally and externally at strategic level.
• Provide input and feedback to Senior Management, Line Manager, or individual team members performance.
• Provide mentorship to Associate Project Manager(s) and Project Managers specific to projects assigned to them.
• Serve as proxy for the management of project managers as needed.
• Assist with business development efforts through ongoing contact with new and assigned clients.
• Aid in regulatory preparation, submission, and oversight of project teams within the program.

Qualifications

• Bachelor's degree in a related field with 5-8+ years of pharmaceutical experience.
• Must have 5 years of Project Management experience managing multi-disciplinary project teams.
• Familiarity with FDA regulations, ICH guidelines, U.S. Drug Development process, Project Management Operations, budgets, ERP, QMS, CRM, and MS Suite.
• Computer proficiency.
• Excellent communication (verbal and written), presentation, and organizational skills.
• Strong negotiation and leadership skills.
• Ability to multi-task and adapt to changing priorities.