Regulatory Drug Project Specialist

Specialist Reg Drug Project

Location:

Gaithersburg, MD

Onsite Flexibility:
Onsite

Position Type:
Contract

Contract Duration: 3 months

Pay Rate: $36.00 / Hour (USD)

Shift /

Schedule:

Required on-site three days a week, with flexible hours (9–5, or 8–4)

Travel Requirements:
This role will not provide relocation assistance

Work Authorization:
Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

This role is intended for a 3–4 month assignment, originally scoped for a summer intern, but open to someone with a basic science degree and minimal post-grad experience. 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.

• 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.

• Strong analytical skills and comfort working with scientific data (as seen in publications — not computer/data engineering).
• Excellent communication skills; must be transparent, open, accountable, and responsible.
• Ability to take direction and execute.
• Experience with data analysis, presentation skills, and ability to search in external sources.
• Ability to report on-site to Gaithersburg (Rio location), MD 3–5 days a week.

• Experience or interest in digital/AI/automation and the regulatory field.
• Enthusiasm for collaboration, cross-functional projects, public speaking, and presentation design.

• Junior or senior undergraduate or Master's student majored in Biology, Life Sciences, Pharmaceutical Sciences, Data Science, Engineering, or a related field.
• Preferred educational background:
  Bachelor's in health or biological sciences (biochemistry, clinical research, regulatory affairs, etc.); a Master's is also acceptable.

• Minimum experience outside of school is acceptable; approximately one year of experience is sufficient, as the original intention was for a soon-to-graduate intern.

• Prior exposure to regulatory affairs, oncology regulatory approval processes, or related life sciences research.

• Interview process: 2-round interview — (1) 30-minute video with hiring manager only; (2) 30-minute video with hiring manager and line manager, including a 10-minute presentation by the candidate. Details will be sent via email if the candidate advances to the second round.
• Titles such as "Research Associate" are considered a strong fit for this position; the exact title of "Specialist Regulatory Drug Project" is not required.
• This role will not provide relocation assistance.

• Medical, Vision, and Dental Insurance Plans
• 401k Retirement Fund

GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. We highly value diverse and inclusive workplaces and support Fortune 500 organizations across banking, financial services, technology, life sciences, biotech, utilities, and retail sectors throughout the U.S. and Canada.