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

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

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.

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

Qualifications

• 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.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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