Associate Specialist, Portfolio & Program Management - Hybrid

Merck & Co. • Philadelphia, PA

134d • $70,500 - $110,900 • Onsite

About The Position

The Associate Specialist of Regulatory Planning & Publishing works closely with various stakeholders of regulatory and safety submissions to assist in activities related to planning, execution, and management of delivery of high quality and timely regulatory submissions. The responsibilities of the incumbent may include the following: 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, as appropriate Participate in training courses to increase job role skills and regulatory knowledge.

Requirements

• High School Diploma or equivalent (no relative experience)
• Ability to communicate effectively, both verbally and written with others across cultures and organizational levels
• Demonstrates the ability to independently solve problems that arise within job responsibilities and expectations of this role
• Familiar with computer systems (MS Office necessary; Advanced Excel and Word skills preferred)
• Highly organized individual with keen attention to detail

Nice To Haves

• Demonstrated leadership, initiative, and ownership of deliverables

Responsibilities

• Support in the creation of FDA cover letters and forms
• Creation of submission plans
• Assist in tracking deliverable timelines of components
• Archiving in systems
• Provide regulatory submission/systems support
• Manage regulatory documents
• Assist in tracking timelines/deliverables and/or components
• Promptly respond to updates

Benefits

• Medical, dental, vision healthcare and other insurance benefits (for employee and family)
• Retirement benefits, including 401(k)
• Paid holidays
• Vacation
• Compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Chemical Manufacturing
• Education Level: High school or GED