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Regulatory Scientist

TekWissen LLC

Research Triangle Park, NC

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JOB DETAILS
SALARY
$25–$25
SKILLS
Agricultural Science, Analysis Skills, Biochemistry, Bioinformatics, Biology, Biotech and Pharmaceutical, Communication Skills, Cross-Functional, Detail Oriented, Diversity, Establish Priorities, Food Safety, Genetics, Genomics, Immunology, Microbiology, Molecular Biology, Multitasking, Presentation/Verbal Skills, Product Safety, Product Support, Regulations, Regulatory Reports, Regulatory Submissions, Reporting Skills, Risk Analysis, Safety/Work Safety, Scientific Principles, Technical Writing, Time Management, Toxicology, Workforce Management
LOCATION
Research Triangle Park, NC
POSTED
2 days ago
Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. The below job opportunity is to one of Our clients who is a leading global provider of agricultural science and technology, in particular seeds and crop protection products, with its management headquarters in Basel, Switzerland, and further locations in Chicago, Tel Aviv, and Shanghai.
Job Title: Regulatory Scientist
Location: Research Triangle Park, NC, 27709
Duration: 12 Months
Job Type: Temporary Assignment
Work Type: Hybrid
Job Description:
Role Profile:
  • Client's Seeds Product Safety group is committed to applying world-class science and winning innovation to offer farmers safe, cost-effective solutions that address the demands of a rapidly changing world.
  • We are looking for a regulatory scientist contractor to join our Consumer and Environmental Safety Team.
  • This is an entry level position with extensive career growth opportunities. As a Regulatory Scientist, you will primarily be responsible for understanding and interpreting the data requirements of human and animal safety assessments for our genetically modified (GM) or genome edited (GE) crop products.
  • You will apply the principles and scientific methodologies of life sciences in support of product safety assessments, primarily focusing on bioinformatics searches and report preparation, as well as contributing to systematic literature reviews and supporting regulatory submissions around the world.
  • This position has the potential for extension or conversion to a Full-time employment.
Accountabilities:
  • Learn and apply regulatory guidance and study requirements, focusing on allergenicity and toxicity risk assessment for biotech crop products, while developing skills to support broader food and feed risk assessment activities.
  • Be able to understand and follow the established methods to conduct bioinformatic analyses for protein toxin and allergen risk assessments and prepare regulatory reports following internal standards and guidelines
  • Be able to understand and follow the established methods to conduct systematic literature reviews of database and internet records for required information, including but not limited to: target gene(s) and their gene products, mode of action, impact on metabolic pathways, history of safe use in food and feed, etc., relevant to the safety assessment of our products.
  • Effective communication with stakeholders regarding any technical issues encountered, impacts, and proposed solutions.
  • Independently review published literature and internal technical documents to prepare technical documents on risk assessment topics.
  • Ability to manage and prioritize multiple project responsibilities within cross functional teams for timely delivery.
Qualifications:
  • BS or MS degree in relevant biological sciences with 0-2 years of relevant professional experience or equivalent combination of education and experience in life sciences such as molecular biology, biochemistry, microbiology, immunology, or toxicology is required.
  • Good understanding of bioinformatics (familiarity with NCBI and UniProt databases, FASTA and BLAST search methodologies) is essential to this role.
  • Proficiency in identifying, reviewing, categorizing, and summarizing scientific literature to address a technical question is highly desirable.
  • Knowledge of food and feed safety (hazard risks and nutritional impact) is a plus.
  • Strong work ethics and independence in completing designated tasks are a Must.
  • Effective written/verbal communication and strong analytical skills with attention to details.
  • Ability to efficiently and effectively organize one's own work, prioritize and work on multiple projects simultaneously.
TekWissen Group is an equal opportunity employer supporting workforce diversity.

About the Company

T

TekWissen LLC

WE THE TEKWISSEN PEOPLE

TekWissen offers you a broader portfolio of services, industry-leading solutions, and the meaningful innovations that give you greater flexibility and speed to respond to market dynamics, reduced costs and risk to improve enterprise performance, and increased productivity to enable growth.

To keep pace with global market demands, TekWissen keeps its finger on the pulse of change. Our organized approach to guiding a project from its inception to closure. Managing projects is becoming more and more important as we enter the digital era. To cope with the pace that this transition demands, a method is required to manage projects so they can yield quality work, while incorporating efficient use of time and resources.

Project involves identifying which quality standards are relevant to the project and determining how to satisfy them.

It is important to perform quality planning during the Planning Process and should be done alongside the other project planning processes because changes in the quality will likely require changes in the other planning processes, or the desired product quality may require a detailed risk analysis of an identified problem. It is important to remember that quality should be planned, designed, then built in, not added on after the fact.

Capabilities and accomplishments in one TekWissen business enhance the opportunity for success in the others. Put simply, TekWissen's unique combination of attributes promotes success.



COMPANY SIZE
100 to 499 employees
INDUSTRY
Computer/IT Services
FOUNDED
2009
WEBSITE
http://www.tekwissen.com/