Study Director II

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.

Job Summary:
The Study Director has overall responsibility for the technical conduct of all assigned tests as well as for the review, interpretation, analysis, documentation, and reporting of results.

The study director is the single point of study control.

The study director ensures all assigned studies are completed on time.
A Study Director II must have sufficient scientific knowledge and communication capabilities to build and maintain customer relationships.

A Study Director II will represent well the testing they oversee both verbally and in writing.

He/she may also be assigned supervisory responsibilities while in this role.

Essential Duties:
All responsibilities as outlined in the Study Director I job description in addition to the following:
Scientific/General


* Ensure final report templates (FRTs) are compliant with procedures.


* Collaborate, review, and approve Customer Specification Sheets (CSS).


* Collaborate on the test method and equipment validations.


* Act as document owner for Standard Test Procedures (STP) as assigned.


* Supervise and manage as assigned.

Regulatory & Compliance


* Resolve assigned Quality Events (QE).


* Assist in hosting laboratory auditors and other visitors.


* Professional Development


* Review current technical and scientific information and contribute content to publications as assigned.

Customer Service


* Collaborate with Sales on project estimates and customized quotes as needed.


* Communicate business strategy, product life cycle, and laboratory offerings to customers.


* Communicate with sponsors regarding a resolution of service and testing issues (e.g., quality events, turnaround time, concerns, etc.)

Project Management


* Coordinate with sponsors and other sections regarding test requirements for routine and non-routine studies.

Perform all other duties as assigned.

Competencies of this position
All requirements, as outlined in the Study Director I job description in addition to the following:
Technical


* Medical Device, Pharmaceutical, and Biomedical Industry knowledge as relates...