Technical Consultant / Medical Advisor

Job Description

Primary Job Function

Provide direction to ensure development of a strategy for the division’s medical oversight performance function. Provide input and oversight for clinical performance functions including monitoring of safety related items (i.e.
complaints, MDRs), reporting, evaluation, and Health Hazard Evaluations and safety. The advisor will also oversee the Medical Information and Professional Education functions of the department. 

Under the supervision of the DVP of Medical Affairs, provides direction in establishing and implementing required safety processes and procedures for new technologies as clinical studies are implemented, worldwide regulatory
approvals are obtained and are commercialized. Oversees the medical information and professional education functions in medical affairs, supervising empoyees involved in those functions. 

Core Job Responsibilities

Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

· Under DVP oversight, provide medical oversight for on-market product and product performance functions, including monitoring of product safety related items (i.e. complaints, MDRs), reporting, evaluation, and Health Hazard Evaluations and safety in clinical study design. 
· Reviews and evaluates product performance data and trends to provide early identification of issues related to product performance or usage concerns in order to minimize clinical safety risk. This includes designing changes to product performance assessment and management to improve ongoing monitoring and risk assessment. 
· Makes appropriate product and procedural recommendations, and works closely with doctor/patient related issues for the safety of drug eluting stents, coronary, endovascular and structural heart and clinical study activities. 
· Provide training for the Product Performance group. Works cross functionally with division Compliance, Clinical Science, Regulatory Affairs, and Commercial organizations as required. Requires involvement with all on-market product
performance, clinical product performance, compliance, clinical, clinical science, medical information, professional education, scientific, and regulatory groups.
· Interact with internal compliance organization, FDA and/or international regulatory bodies, as required, in response to product performance inquiries and clinical study product performance matters, to enhance business growth opportunities.

– Manage a small team of staff engaged in medical information, safety and professional
education functions.

Provides medical support to the Office of the Chief Medical Officer that includes representing the Division at Medical Conferences and Physician/Hospital interactions, as required by the DVP or CMO.

Comments

Will also
cross-functionally interact with PPG, QA, Clinical Safety, Clinical R&D and other parts of the CMO’s organization. 

Skills

Position Accountability / Scope

Has daily responsibility/scope for on-market product performance and clinical study product performance, including post-market clinical data from commercial use of products.

Erroneous decisions will have an effect on product performance, reputation of company with regulatory agencies and will have a long term effect on the company’s success, goodwill and reputation. AV’s ability to coordinate the critical functions of Medical Information and Professional Education would be adversely affected.

Assists DVP in the translation of programs established by top management into operational plans and schedules.

Reports directly to the Divisional Vice President of Medical Affairs and Product Performance in the office of the Chief Medical Officer, and will use appropriate judgment on which situations require discussion and guidance. Strategy and diplomacy are required because of frequent and ongoing involvement with Directors in the organization, governing/regulatory bodies and medical professionals.

Strong teamwork and collaboration with quality/compliance, product operations, clinical, regulatory affairs, manufacturing, and commercial organizations.

Qualifications

Minimum Education Advanced degree preferred, with a strong background in medicine, nursing or catheterization laboratory technology; and a minimum of 15+ years work experience or equivalent combination.

Minimum Experience / Training Required Candidates must possess skills in science and have a thorough understanding of scientific methods as they apply in clinical studies. Some business experience preferred.

Excellent written and communication skills.

Exceptional technical skills and knowledge.

Polished presentation skills are important as this position may be asked to represent the company to physicians and healthcare forums.