Manager, Delivery Solution Clinical & Submission Support

AbbVie is looking for an engineer to join their Combination Product Development (CPD) team to lead the efforts in supporting design validation, clinical trials and regulatory submission for the development and launch of new drug delivery systems.

This individual will represent CPD in the support of clinical trials, regulatory submissions and, commercial launch of new products.

Responsibilities include the following:

• Clinical Trial Support: Coordinates CPD activities related to clinical study preparation and execution including support to complaint handling
• Design Validation:
• Designs, executes and summarizes simulated-use and/or "real-life/home-use" study
• Joint Human Factor Engineers (HFE) in the efforts of planning, executing and summarizing HFE Validation/Summative study

• Regulatory Submission Support: Authors/approves regulatory submission documents and coordinates devices sessions with regulatory team
• Commercial Launch Support: Assists in the preparation of training materials and training during commercial product launch
• Product life cycle strategy support: obtains and communicates on-market product experience; and assist in the development of product life cycle strategy

In addition, it is expected that this group will be engaged with clinical, project development, quality, regulatory, and commercial teams, and external engineering partners. These activities will require the development and fostering of relationships with these groups.

Required Skills / Experience:

• Minimum of 3 years in device and/or drug-device combination product development
• B.S, MS or Ph.D. in Engineering is preferred
• Strong medical product experimental skills, as well as a sound understanding of medical product laboratory practices and equipment.
• Experience in design validation.
• Experience in regulatory submission supporting the device constituent part of a combination product submission.
• Familiarity of clinical trials and clinical trial support.
• Strong analytical, decision making, and communication (spoken and written) skills.

Travel may be required, if necessary.