Job detail for Regulatory Intern for Global Clinical Trial Operations

Job Description

Our GCTO Division maintains an ideology of “patient first, profits later.” The organization is composed of sales, marketing, market access, digital analytics, and commercial professionals who are passionate about their role in bringing our medicines to our customers around the world.

Our regulatory affairs team brings new medical breakthroughs to the world by facilitating the communications and procedures that allow for rapid and organized compliance with external regulatory agencies. We are at the forefront of healthcare advances that help provide new, compliant, and trusted medical products, practices, and solutions to the world.

Position Objectives:

• Provide administrative support in the development and preparation of dossiers submitted to regulatory authorities (e.g., clinical trial authorization applications, protocol amendments, import license applications, etc.)
• Monitor dossiers submitted to regulatory authorities, provide periodic reports, and escalate issues as applicable
• Perform preliminary review of standard documents (e.g., certificate of analysis) using verification tools (e.g., checklists)
• Provide administrative support in the coordination, collection, organization of data and information, and drafting of documents required by local authorities (e.g., ethics committees, INS), clinical teams, and headquarters
• Edit and review informed consents (e.g., global, assent, future biomedical samples, etc.) according to local regulations and internal processes
• Provide support in the submission of safety reports (SUSARs) to Ethics Committees
• Actively participate in initiatives and/or projects for regulatory process improvement
• Interact with other internal support areas as needed (e.g., , procurement, finance, etc.)
• Manage regulatory documentation

Requirements:

• University students in Pharmacy and/or Biochemistry (or similar)
• Intermediate level of English

Required Skills:

Clinical Research, Cloud Data Catalog, Data Analysis, Database Management, Data Science, Data Security, Data Visualization, Data Wrangling, Detail-Oriented, Event Planning, Key Performance Indicators (KPI), Project Management, Python (Programming Language), Software Proficiency, Vendor Relationship Management

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Intern/Co-op (Fixed Term)

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

10/13/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.