Job Details

ID #2799959
Estado Illinois
Ciudad Northchicago
Full-time
Salario USD TBD TBD
Fuente AbbVie
Showed 2019-10-22
Fecha 2019-10-22
Fecha tope 2019-12-20
Categoría Etcétera
Crear un currículum vítae

Manager, Delivery Solution Clinical & Submission Support

Illinois, Northchicago 00000 Northchicago USA

Vacancy caducado!

Manager, Delivery Solution Clinical & Submission SupportUSA, Illinois, Lake CountyNewResearch & DevelopmentRequisition #1906713AbbVie 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:

Minimumof 3 years in device and/or drug-device combination product development

B.S,MS or Ph.D. in Engineering is preferred

Strongmedical product experimental skills, as well as a sound understanding ofmedical product laboratory practices and equipment.

Experiencein design validation.

Experiencein regulatory submission supporting the device constituent part of a combinationproduct submission.

Familiarityof clinical trials and clinical trial support.

Stronganalytical, decision making, and communication (spoken and written)skills.

Travel may be required, if necessary.Additional Information

AbbVie is an Equal Employment Opportunity employer: 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.

Significant Work Activities and Conditions: N/A

Travel: Yes, 20 % of the Time

Job Type: Experienced

Schedule: Full-time

Vacancy caducado!

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