Senior Human Factors Specialist

Company Description

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

In 2023, Eurofins generated total revenues of EUR 6.515 billion, and has been among the best performing stocks in Europe over the past 20 years.

Job Description

Our Team

Our small and close-knit team is made up of individuals who have been working human factors for longer than we care to admit. We are fierce in most everything we do as our goal is to optimize not only our clients’ experience but to put them in the best position possible when it is time for FDA review. We do not view human factors as just another checklist; we view human factors as a critical component of not only a successful submission but a successful product.

Overview

The Senior Human Factors Specialist is responsible for providing high level expertise and consultation on human factors activities. More importantly, our technical directors are primary contributors as it pertains to study protocol development, study moderation, and reporting. Our direct contribution to studies, coupled with our senior-level program management, is one of our key differentiators in the marketplace. Our Senior Human Factors Specialist thrive in our fast-paced environment working with multiple clients and on multiple programs at any given time.

The Technical Director duties and responsibilities include but are not limited to:

1. Manage multiple programs and projects at various stages of the human factors timelines (e.g., early in the client’s product development or late-stage).
2. Plan, conduct, and report on human factors activities in support of customer programs. You will be expected to moderate your own studies or support by moderating other studies as needed.
3. Activities may include but are not limited to:
   1. Authoring protocols and reports.
   2. Study moderation (yes, we moderate our own studies and help each other when we need to).
   3. Authoring use-related risk documentation.
   4. Helping clients with FDA requests / attending FDA meetings (usually virtually).
   5. Plan HF strategies that are not overly burdensome and are pragmatic / make sense.
   6. Support finance by managing our budgets, 3rd party contractors, so we can know when and who to invoice.
   7. And in general, help our clients solve hard problems and bring cool new stuff to market! Not getting it stuck in a bunch of red tape!
4. Maintain expertise in human factors knowledge and methods and human factors regulatory requirements ensuring the knowledge is current and in keeping with the latest industry trends.
5. Manage contractors or other vendors, including 3rd party recruiters and facilities, as appropriate.
6. Conduct work activities in compliance with negotiated timelines and budgets.
7. Identify and communicate to Human Factors MD new opportunities to support clients or new work prospects in support of Human Factors MDs business development objectives.
8. Provide support and guidance to other staff members as appropriate.
9. Conduct work activities in accordance with Human Factors MD Quality Management System
10. Carry out any other tasks as assigned by the Managing Director.

Qualifications

Preferred Qualifications

1. Graduate degree in Human Factors or a related discipline.
2. A deep understanding