Regulatory Submissions Associate Specialist – Hybrid

Merck & Co.; Philadelphia (Philadelphia County); Hybrid; USD 72,000 - 113,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Retirement benefits (401(k))

Paid holidays

Vacation

Sick days

Job summary

Merck & Co. seeks an Associate Specialist in Regulatory Planning & Publishing to assist in planning, execution, and management of timely regulatory submissions. The role is based at the Philadelphia, PA WeWork Office in a hybrid schedule requiring 3 days in the office.

You will support FDA cover letters, submission plans, and document archiving, while coordinating with regulatory teams. The position emphasizes process improvement, document control, and timely deliverables, with a strong focus on

Qualifications

• Ability to communicate effectively, both verbally and written with others across cultures and organizational levels.
• Demonstrates the ability to independently solve problems.
• Familiar with MS Office; Advanced Excel and Word skills preferred.
• Highly organized with keen attention to detail.

Responsibilities

• Maintain accountability for use of established planning and tracking practices and systems.
• Participate in pilots for new tools and processes.
• Collaborate with colleagues inside and outside of the department.
• Participate in training courses to increase job role skills and regulatory knowledge.

Skills

Accountability

Communication

Computer literacy

Customer satisfaction

Deliverables management

Document control systems

Independent thinking

Microsoft Word

Taking ownership

Working independently

Project Management

Education

High School Diploma or equivalent

Job description

Merck & Co. seeks an Associate Specialist in Regulatory Planning & Publishing to assist in planning, execution, and management of timely regulatory submissions. The role is based at the Philadelphia, PA WeWork Office in a hybrid schedule requiring 3 days in the office.

You will support FDA cover letters, submission plans, and document archiving, while coordinating with regulatory teams. The position emphasizes process improvement, document control, and timely deliverables, with a strong focus on