Senior Documentation Specialist

10 hours ago


Rahway, New Jersey, United States Spectraforce Technologies Full time
Job Title: Senior Documentation Specialist

At Spectraforce Technologies, we are seeking a highly skilled Senior Documentation Specialist to join our team. As a key member of our Global Regulatory Affairs & Clinical Safety (GRACS) organization, you will be responsible for supporting the operational aspects of procedural documentation management and advising on documentation strategy.

Key Responsibilities:

  • Support GRACS Document Owners and Functional Areas in the development, revision, implementation, and maintenance of procedural documentation.
  • Collaborate with Business Process Leads, Functional Leads, Document Owners, and Subject Matter Experts to ensure documentation conforms to MRL standards.
  • Facilitate documents through draft, review, and approval cycles to meet required timeframes for release and implementation.
  • Conduct periodic assessment of procedural content to ensure adherence to format, content, and style guidelines.
  • Support and manage the overall documentation change control process and related systems.

Requirements:

  • 6+ years industry experience and familiarity with Regulatory Affairs and Global Pharmacovigilance Procedural Documentation.
  • Must have a Bachelor's degree or higher for this role.
  • Veeva Vault Quality Docs experience preferred.

What We Offer:

Spectraforce Technologies offers a dynamic and challenging work environment with opportunities for growth and development. We are committed to providing our employees with the tools and resources they need to succeed.



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