Regulatory Planning & Submissions Specialist

Merck; Philadelphia (Philadelphia County); Hybrid; USD 72.000 - 113.000; Vollzeit

Zusammenfassung

Merck is seeking an Associate Specialist in Regulatory Planning & Publishing in Philadelphia, PA on a hybrid schedule (3 days in-office). The role supports planning, execution, and management of timely regulatory submissions and documents.

Responsibilities include creating submission plans, FDA cover letters, and tracking deliverables while collaborating across teams and participating in training to enhance regulatory knowledge.

Qualifikationen

• High School Diploma or equivalent required.
• Ability to communicate effectively across cultures and levels.
• Familiar with MS Office; Advanced Excel and Word skills preferred.
• Highly organized with keen attention to detail.

Aufgaben

• Maintain accountability for established planning and tracking practices.
• Participate in pilots for new tools and processes.
• Collaborate with colleagues inside and outside the department.
• Assist in creation of submission plans and FDA cover letters.
• Manage regulatory documents and track timelines/deliverables.

Kenntnisse

Accountability

Communication

Computer Literacy

Customer Satisfaction

Deliverables Management

Document Control Systems

Independent Thinking

Microsoft Word

Taking Ownership

Working Independently

Project Management

Ausbildung

High School Diploma or equivalent

Tools

MS Office

Advanced Excel and Word

Jobbeschreibung

Merck is seeking an Associate Specialist in Regulatory Planning & Publishing in Philadelphia, PA on a hybrid schedule (3 days in-office). The role supports planning, execution, and management of timely regulatory submissions and documents.

Responsibilities include creating submission plans, FDA cover letters, and tracking deliverables while collaborating across teams and participating in training to enhance regulatory knowledge.