Job Listing: Toxicologist

Primary Purpose of this position:
Plan and conduct safety/toxicological reviews, risk assessments, product safety clearances, clinical study claims, and safety information searches in support of product development.
Essential Functions:
- Conduct routine safety/toxicological reviews for raw materials, product manuals, specifications, mechanicals, study designs, and
test reports, etc.
- Conduct safety/risk assessments based on established SOPs for global safety compliance. This includes making informed judgments based on literature searches and vendor information.
- Implement the product safety clearance program under the Senior Manager / Director’s guidance.
- Search and provide detailed information regarding the guideline and requirements for product safety and claims substantiation for different international markets, and implement the testing plan accordingly.
- Keeping up-to-date with new technology in clinical research from industrial or scientific associations and assisting in designing clinical protocols for product efficacy and claim substantiation.
- Assist the Director with preparation and submission of the clinical study protocol, informed consent, and any other required paperwork for compliance with 21 CFR 54, 56 and ICH GCP (international Conference on Harmonization Good Clinical Practice) guidelines.
- Assist in the review of clinical study records; compare case reports forms with source documents; review accountability records and other study files.
- Identify and communicate to the Senior Manager / Director any study issues that may impede the timeline of expected deliverables
to product development. Act on Senior Manager / Director’s recommendation for product reaction follow-up to determine
resolution and path forward.
- Search toxicological information to support special safety projects and industry-wide issues.
- Request and receive formal written feedback/progress reports from each study site and address areas for improvement in a
proactive and conscientious manner; record communications as applicable (verbally, electronically, or by telephone with Product Investigators, Institutional Review Board (IRB) or laboratories, etc.); and ensure communication with the IRB/investigators/Playtex regarding adverse events, safety reports, protocol amendments, committee reviews, and informed consent modifications.
- Consolidate information into the safety toxicological database.
- Serve as a liaison between Product Development, Consumer Affairs and Senior Manager / Director, Product Safety for product stewardship.
- Prioritize and direct the work of the Product Safety staff to insure commitments are met. Develop personnel, set performance expectations and coach to help achieve goals and obtain the skills necessary to meet work requirements.

Experience/Education Required:
- B.S. degree in Toxicology, Pharmacology, or a relevant technical field.
- 4 – 8 years experience in the OTC / Cosmetic industry providing product safety support and conducting clinical testing at progressively increasing scientific levels per GCP (Good Clinical Practices).
- Experience with global cosmetic and / or medical device safety requirements.
- Basic knowledge of the REACH (Registration, Evaluation, and Authorization of Chemicals) compliance program is a plus.
- Prior supervisory experience. The ability to accurately forecast human resource needs and staff requirements. Strong coaching
and mentoring skills.

Required Skills for Toxicologist Job:

About Aerotek Scientific:

Join Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers.