Senior Manager, Delivery Solution Clinical & Submission support

Lake County, IL, US
Oct 21, 2019
Required Education
Bachelors Degree
Position Type
Full time
AbbVie is looking for a Senior Manager 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:
    • Plan/Design and communicate outcomes of simulated-use study
    • Work with clinical and other organization in planning and executing "real-life"/"home-use" studies
    • Joint Human Factor Engineers (HFE) in the efforts of planning and summarizing HFE Validation/Summative study
  • Regulatory Submission Support: Authors/approves regulatory submission documents and coordinates devices sessions with regulatory team
  • Commercial Launch Support: represents CPD in the preparation of training materials and training for commercial 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 individual 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:
  • BS in Engineering (Mechanical, Chemical, etc) with 7+ of experience OR BS in Science (Chemistry, Biology, etc) with 10+ years of experience.
  • 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, as necessary.