Engineering Project Coordinator, Combination Products

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines 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, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Primary responsibilities and influence on AbbVie

The Project Coordinator is accountable for leading the cross functional team (Engineering, Quality, Supply Chain, Marketing, Operations, Human Factors, Project Management, and External Partners) in the execution of a portfolio of projects focused on the delivery system constituent parts of a combination product (Devices, Primary Packaging, Accessories, Secondary Packaging, Instructions for Use and Labeling). The Project Coordinator ensures that the strategy and plans defined for assigned programs are aligned with the needs of the patient and customer and the business objectives of the CMC and Asset team. In addition, product development timing and scope need to support plans for CMC gate reviews and each clinical phase.

Summary of Responsibilities and Accountabilities:

The Project Coordinator will be accountable to the CMC team, the CMC Product Development Director and delivery system Senior Leadership for delivering on the strategy, plans and budget defined for the project portfolio.

Responsibilities include:

• Support of a portfolio of drug delivery system product development projects
• Lead collection of project information and other data collection, establish harmonized/standardized reporting and tracking tools, manage shared site(s) for information dissemination
• Representing the R&D organization to crossfunctional leadership through effective and timely communication
• Ensuring effective use of meetings by clearly defining objectives, agendas, inviting the team members specifically needed and publishing minutes and actions
• Ensure timely execution of incoming reportable device combination product events to comply with global regulations.
• Driving continuous improvement on project management processes and tools
• Develops and implements project management tools and project/program reports/dashboards
• Work for crossfunctional teams to perform scenario analysis to mitigate risks, develop contingencies and provide insights into program recommendations

Management of External Partners: The Project Coordinator supports the team in managing the relationship and performance of key external device development partners. An effective and efficient development partner governance process should be defined and implemented including: key interface definition, meeting cadence, schedule performance monitoring, project scope/change control, issue escalation, and financial tracking. Program risks must be identified and mitigated with the partner throughout the program lifecycle. The Project Coordinator will ensure timely and efficient communication regarding partner performance will be provided to the broader AbbVie organization as required.

Impact on AbbVie: The role of a Project Coordinator has broad influence and impact on the development and launch of AbbVie's assets when a device/combination product delivery system is required. These device systems are often technically complex, involve multiple sub-systems, interface directly with the patient, and must meet global requirements. Typically, external partner management is required. The Project Coordinator must represent the R&D function to cross functional leadership through effective communication and use of influence skills

Qualifications

Qualifications:

• Bachelor's Degree in Engineering or related technical field
• Certification: Project Management Professional (PMP) Certification preferred, but not required
• 7+ years of experience in the combination product, medical device and/or pharmaceutical industry
• Skilled in the initiation, selection, coordination and management of projects and have the ability to solve unique problems
• Design history file, project management and product development experience is essential
• Conflict resolution skills including effective persuasive techniques with senior-level colleagues is key.
• Excellent communication and people management capabilities
• Must have working understanding and application of Design Control principles, concepts, practices and standards as well as relevant related regulatory requirements for commercialization in diverse global markets (United States, Europe, Asia, Latin America)
• Up to 20% travel may be required to effectively manage communication between multiple Abbvie sites and third-party suppliers

Significant Work Activities
N/A
Travel
Yes, 10 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.