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 . 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.
- Author and support device sections of early-stage regulatory submission documents.
- Contribute to continuous improvement initiatives within device clinical management and cross-functional teams.
Qualifications
- BS in engineering / science related discipline or equivalent education with typically 7 or more years of experience or MS or equivalent education with typically 5 or more years of experience.
- Familiarity with medical devices, combination products, and/or pharmaceutical industry, inclusive of design controls.
- Ability to collaborate cross functionally and maintain productive internal and external relationships.
- Effective technical writing and verbal communication skills.
- Strong willingness to learn and develop problem-solving skills.
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 ofthis 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.
This job is eligible to participate in our long-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 anybonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's soleand 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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