Regulatory Specialist or Regulatory Associate
Synectics Inc. · Gaithersburg, MD · 3 wk ago
ScienceContract
About the role
Support data validation activities in our digital tool for oncology regulatory approval information. Help with presentation of regulatory intelligence data analyses using AI tools. Undertake background literature research for regulatory intelligence queries using publicly available and commercial tools. Research and analyze regulatory guidance and precedence to support our products and development pipeline.
Required on-site three days a week, with flexible hours (9-5, or 8-4).
Requirements
- Junior and senior undergraduate or Masters student majored in Biology, Life Sciences, Pharmaceutical Sciences, Data Science, Engineering or a related field.
- Bachelor's in health or biological sciences (biochemistry, clinical research, regulatory affairs, etc.).
- Experience with data analysis, presentation skills, and ability to search in external sources required.
- Experience or interest in digital/AI/automation and the regulatory field an added plus.
- Enthusiasm for collaboration, cross-functional projects, public speaking, and presentation design.
- Analytical skills and comfort working with scientific data (as seen in publications).
- Good communicator, transparent, open, accountable, and responsible—not necessarily strong in presentations, but able to take direction and execute.
- Minimum experience outside of school is acceptable.
Benefits
- Healthcare Insurance: Eligible employees and their dependents receive healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full-time employment. Premiums are subsidized by Synectics.
- Dental Insurance: Eligible employees and their dependents receive a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full-time employment.
- Vision Insurance: Eligible employees receive vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full-time employment.
- 401(k) Plan: Synectics offers all employees aged 21 or older the opportunity to invest in the 401(k) Plan on the first of the month following at least one calendar year of employment.