Merck & Co.-posted 3 months ago
$70,500 - $110,900/Yr
Full-time • Entry Level
Onsite • Philadelphia, PA
Chemical Manufacturing

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.

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