Associate Project Manager, DCPD Clinical Support

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

Purpose:

The AbbVie R&D Device and Combination Product Development (DCPD) function provides device development expertise for Aesthetic Devices and Therapeutic Combination Products. Within this space, DCPD is accountable to enable AbbVie’s Early R&D Pipeline by providing support to AbbVie’s clinical cross-functional partners to ensure the successful inclusion of devices and drug delivery systems throughout the entire process.

We are seeking an Associate Project Manager, DCPD Clinical Support, to support initiatives and prepare for clinical trials involving devices and drug delivery systems that enable the early-stage pipeline. Collaboration with clinical teams is crucial in this role. You will play an integral part in coordinating efforts between clinical operations, clinical supply, clinical development, regulatory, quality, human factors, and the device development teams to ensure readiness for all phases of clinical trials. 

Responsibilities:

• Support clinical trial readiness activities for device and drug delivery systems, including coordination with clinical supply, study preparation, and regulatory submission.
• Assist with device-related activities in global clinical studies from start to finish, including complaint handling and ensuring compliance with global regulations.
• Collaborate proactively with human factors, systems engineering, and broader device teams to design and execute design validation plans within design controls process.
• Support the development of administration instructions used for clinical trials.
• Partner with clinical development and operations to create and deliver clinical training materials.