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 to section and testing offerings.
• Understanding of company structure and imperatives.
• Professional
• Basic financial acumen and NL business understanding.
• Conflict management skills
• Presentation skills
• Supervisory skills
• Effective communication skills specific to technical concepts, problem identification, and solutions.
• Demonstrated effective technical writing ability.

Work Environment:
This job operates in a professional laboratory environment. This role routinely uses standard office equipment and lab equipment including but not limited to computers keyboards, computer mouse, telephones, photocopiers, file cabinets, microscopes, micropipettes, pipette aids, various hand tools, and analytical equipment.
The possibility exists for exposure to biological and chemical hazards, exposure to carcinogenic compounds, and other environmental aspects which may be considered unfavorable. Employees are expected to follow Biosafety and Chemical Hygiene policies, practices and procedures.
Travel:
Occasional local travel during the business day and occasional out of the area or overnight travel may be expected.

Physical requirements:
The physical demands described here are a representative of those that must be met to perform the essential job functions.

• Requirements to stand and traverse to various office and lab locations and sit at a computer workstation will vary.
• Bending, stooping, and crouching.
• Occasional push and pull tasks with one or both hands.
• Must be able to work while wearing personal protective equipment such as safety glasses, goggles, face shields, gloves, lab coats and personal protective equipment deemed necessary to protect testing and to protect employees from various solutions, wastes, etc.
• Must be able to lift up to 45lbs.

Education and experience requirements:

• M.S. degree (life science strongly preferred) or
• B.S. degree (life science strongly preferred), and a minimum of one year Study Director I experience or
• A.A./A.S. or equivalent and three years NL laboratory experience as a Study Director I
• Successful completion of Study Director Training

Sotera Health goes to market through its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®. Sterigenics is a leading global provider of outsourced terminal sterilization and irradiation services for the medical device, pharmaceutical, food safety and advanced applications markets. Nordion is the leading global provider of Co-60 and gamma irradiators, which are key components to the gamma sterilization process. Nelson Labs is a global leader in outsourced microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries.