Description:
General Summary:
This key position is responsible for being a technical and general advisor to Boston Scientific Corporation providing Medical/clinical support and guidance for formulating clinical strategy and making clinical decisions. This includes providing medical and scientific expertise in certain therapeutic areas to bring high quality and efficiency to the clinical trial development process for devices in the product development pipeline.

Duties and Responsibilities:
- Provides detailed medical/therapeutic guidance to internal and external customers including project teams, other functional units, investigators, and regulatory agencies and assists with meeting project timelines.
- Provides early, hands-on operational support to teams in clinical trial planning, protocol development, investigator selection, training of internal and external personnel, medical monitoring for trial safety, data analysis/interpretation, and quality control.
- Responsible for providing therapeutic area expertise to support development and execution of clinical trials in device development process.
- Reviews and edits protocols to insure accuracy, consistency with standard of care, logistical ease, and internal consistency with BSC requirements.
- Delivers direct physician support to quality assurance group for review of product complaints, MDR reporting criteria, health risk assessments, and product performance criteria.
- Envisions the application of new technologies in novel ways to solve complex medical device needs.
- Writes and edits clinical and scientific reports for regulatory submission and scientific communication.
- Cultivates relationships with influential thought leaders in the medical community.
- Reviews and summarizes medical literature.
- Attends and potentially participates in National, International, and Regional meetings and summaries current medical issues discussed within them
- Reviews and approves product education, promotion, and reporting materials

Minimum Education & Experience:
Medical degree required with board certification in area of therapeutic expertise. At least 5 years of clinical experience with patient care. At least 5 years of clinical trial experience is required. Some direct industry experience (device, pharmaceutical, and biotechnology) is preferred.

Working Conditions:
General office environment, with up to 40% domestic and international travel to other BSC facilities and or/meetings and conferences.

Support of Quality Systems:
Establish and support a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System, and appropriate regulations for the area they support. Ensure employees are trained to do their work and their training is documented.

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed, as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified

Experience:
see description