Consulting Study Director

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

Sotera Health Company is a leading global provider of mission-critical sterilization and lab testing and advisory services for the healthcare industry.

With a combined tenure across our businesses of nearly 200 years and our industry recognized scientific and technological expertise, we help to ensure the safety of millions of patients and healthcare practitioners around the world every year.

Across our 64 facilities worldwide, we have over 3,000 employees who are dedicated to safety and quality.

We are a trusted partner to more than 5,800 customers in over 50 countries, including more than 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

Consulting Study Director

The Consulting Study Director is a trusted advisor and consultative expert for clients and serves as the initial customer contact for validation studies, large projects, and other testing requiring a high degree of consultation.  The position requires the highest level of customer service and broad section expertise.

Schedule:

Traditional

The consulting study director will assist sales in the quote generation, develop the test protocol, ensure the testing setup is complete, and facilitate a smooth transition of the project to a production study director.  This position allows production study directors to focus on completing testing and on providing the client with exemplary service, testing, and delivery experience which will provide a substantial competitive edge for Nelson Labs. 

The primary duty of the Consulting Study Director is to assist the client in planning and organizing, projects with a high level of availability and specialized expertise.  This will ensure a high-touch customer service experience.

Essential job functions:

Study Consulting


* Demonstrate a deep understand of relevant industry requirements, standards, and guidelines for a section (GMP, GLP, FDA, AAMI, ISO, ASTM, USP, etc.)


* Collaboratively develop test protocols and testing strategies and capture client expectations


* Work with production study directors to ensure a seamless handoff of projects after the initial consult, quoting, and test protocol development


* Work with clients and production study directors to assist with unexpected or unique testing complications.


* Coordinate with technical consulting for summary protocols, written justifications, sample plan justifications, and written risk assessments and special projects.

Customer Focus


* Provide the highest level of customer service


* Extensive customer phone contact is expected


* Develop strong relationships with the client, sales team, service center, and production study directors to ensure the highest level of customer satisfaction

Regulatory Compliance


* Know and follow appl...