Regulatory Content Specialist

6 days ago


Somerville, New Jersey, United States VCLS Full time

Job Title: Regulatory Content Specialist

Location: VCLS

About the Job:

VCLS is seeking a skilled Regulatory Content Specialist to join our team. As a key member of our project coordination and quality assurance team, you will assist in the preparation of regulatory documents and provide project management support.

Key Responsibilities:

  • Document Management:
    • Prepare and review regulatory documents, including protocols, clinical study reports, and regulatory submissions.
    • Organize and categorize documents, ensuring accessibility and version control.
    • Support e-publishing activities (formatting, creating eCTD compliant PDFs, hyperlinking, bookmarking, etc.).
  • Project Coordination:
    • Support project managers in coordinating activities related to regulatory submissions and project milestones.
    • Coordinate with cross-functional teams to ensure completeness and accuracy of submissions.
    • Track submission progress and address any queries or issues raised during the review process.
  • Quality Assurance:
    • Stay up-to-date with regulatory guidelines and industry standards.
    • Conduct document audits to ensure compliance with regulatory requirements and internal standards.

Requirements:

  • Experience: Proven work experience in project management.
  • Technology: Expert level proficiency in Windows and MS Office Suite.
  • Values: Embody our core values - People, Innovation, Passion, and Excellence.
  • Detail-Oriented: Possess a meticulous eye for accuracy and strong organizational skills.
  • Team Player: Thrive in a collaborative environment and demonstrate excellent communication skills.

Benefits:

  • Why VCLS: Make a Difference, Learn and Grow, Hybrid Flexibility, Dynamic Environment, Growth Potential.
  • Salary: $65,000 - $90,000 per annum.


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