Job Description

Consulting Study Director

Classification:

Schedule:

Traditional

Job summary:

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.

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 applicable regulatory requirements (GMP, GLP, ISO, etc.)
• Understand current regulatory trends related to the field of expertise
• Know and follow company policies and procedures

Professional Development

• Complete required training on time
• Keep current on scientific literature, test methods, and best practices

Perform other duties as assigned

Job requirements:

• Exemplary internal and external customer service skills
• Demonstrated technical ability and knowledge
• Strong verbal and written communication skills
• Ability to work with cross functional teams
• Project management skills
• Facilitate client and team meetings
• Must be able to multi-task and be self-motivated
• Time management- must be able to respond to voicemails, emails, and other communications in a timely manner.
• Computer skills: knowledge of Microsoft Office
• Ability to work independently
• Regular and reliable attendance

Physical requirements:

Physical requirements: Must be able to stand/walk 30% of the day and 70% sitting, or at a computer. Must be able to occasionally lift a minimum of 30 pounds.

Education and experience requirements:

B.S. degree (microbiology/biological science or chemistry preferred) and five years of NLI laboratory experience.The name Sotera Health was inspired by Soteria, the Greek g oddess 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 he p 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 8 of the top 10 global pharmaceutical companies.

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. Learn more about Sotera Health at soterahealth.com.

Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity

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