Senior Project Manager, DCPD Clinical Support
Senior Project Manager, DCPD Clinical Support
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Salary Not Disclosed
1 Vacancy
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 AbbVies Early R&D Pipeline by providing support to AbbVies clinical cross-functional partners to ensure the successful inclusion of devices and drug delivery systems throughout the entire process.
We are seeking a Project Manager Clinical Support to spearhead initiatives to prepare for clinical trials involving devices and drug delivery systems and 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. These devices are often technically complex involve multiple sub-systems interface directly with the patient and must meet global requirements.
Responsibilities:
- Support clinical trial readiness activities for device and drug delivery systems working closely with clinical supply study teams quality and regulatory affairs to ensure efficient study initiation and adherence to appropriate standards and compliance.
- Coordinate device-related aspects of global clinical studies including partnering with quality teams on complaint resolution managing documentation and ensuring compliance with regulatory reporting requirements.
- Collaborate with human factors systems engineering and device teams to support design validation planning and execution within design control processes
- Assist in the development and review of administration instructions for use in clinical trials. Contribute to the creation and implementation of training materials for clinical site staff and study teams in partnership with clinical development and operations.
- Author review or contribute to device sections for early-stage regulatory submissions.
- Advise clinical study teams to ensure appropriate representation and integration of device-related aspects in protocol design.
- Drive continuous improvement initiatives within device clinical management and across cross-functional teams leveraging insights and feedback to optimize processes and enhance collaboration.
Qualifications :
- Bachelors Degree or equivalent education and typically 14 years of experience Masters Degree or equivalent education and typically 12 years of experience PhD and typically 6 years of experience.
- Proven experience with medical devices combination products or the pharmaceutical industry including hands-on involvement with design control processes.
- Solid understanding of the pharmaceutical product development lifecycle; prior clinical development experience strongly preferred.
- Excellent interpersonal skills with a demonstrated ability to work collaboratively across functions and build effective relationships both internally and externally.
- Advanced technical writing proficiency and strong verbal and written communication skills.
- Highly adaptable and strong aptitude for identifying innovative approaches to solve problems and support effective decision-making.
- 10% Travel may be required to coordinate between AbbVie sites third-party suppliers and/or clinical sites.
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.
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 any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys 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.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Employment Type
Full-time
