Associate Project Manager, Combination Product Development & Clinical Support (onsite)

AbbVie • North Chicago, IL

264d

About The Position

AbbVie is seeking an Associate Project Manager to drive the execution and oversight of projects across Combination Product Development and Drug Delivery (CPD-DD) to enable the early-stage pipeline. This will be in collaboration with our CMC team, CMC Product Development Director, and Delivery System Senior Leadership. Your role will be pivotal in ensuring alignment with defined strategies, plans, and budgets. Additionally, you will spearhead initiatives to prepare for clinical trials involving drug delivery systems. In this position, you will lead cross-functional teams comprised of Engineering, Quality, Supply Chain, Marketing, Operations, Human Factors, Project Management, and External Partners. Your leadership will be essential in executing projects focusing on key components of combination products, including devices, accessories, packaging, instructions for use, and labeling. You will manage product development timelines and scopes to support CMC gate reviews and clinical phase plans. Collaboration with clinical teams is crucial in this role. You will play an integral part in coordinating efforts between clinical development, operations, and supply organizations to ensure readiness for clinical trials. Your work will include facilitating activities related to clinical study preparation, clinical supply readiness, and regulatory submissions concerning drug delivery systems, ensuring integration and execution across all phases.

Requirements

• BS or equivalent education in Engineering or Science related discipline with typically 7 or more years of experience or MS or equivalent education with typically 5 or more years of experience
• Knowledge and working experience with medical devices, combination products, and/or pharmaceutical industry inclusive of design controls
• Understanding of the pharmaceutical product development cycle
• Leadership of technical professionals; cross-functional teams with focus on qualification in delivery systems
• Skilled in initiation, selection, coordination, and management of projects and can solve unique problems
• Design history file, project management and product development experience are essential
• Conflict resolution skills including persuasive management techniques and effective communication skills required
• Effective writer and communicator of project timelines, risks, and other technical materials

Responsibilities

• Manage the execution of project(s) or sub-sets of larger project(s) across the CPD-DD organization and align cross-functional resources
• Develop realistic cross functional project plans with input from other functions, e.g., Quality and Regulatory
• Tactical and strategic management of external device partners including acting as a key interface, managing the project governance process and forward-looking evaluation of potential partners
• Provide project management support for and guide the efforts of third-party organizations to enable achievement of shared milestones
• Set project milestones and report progress accordingly to appropriate governance and leadership forums
• Utilize the relevant project management tools for project planning, monitoring, and reporting to maintain project budgets and timelines
• Ensure effective use of meetings by clearly defining objectives, agendas, inviting the team members specifically needed and publishing minutes and actions
• Execute activities related to clinical trial readiness with respect to the device/delivery system, including coordination of clinical supply, clinical study preparation, and regulatory submission documents
• Drive continuous improvement on processes and tools

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree