Document Manager

1 day ago

Dublin, Dublin City, Ireland beBeeClinical Full time €60,000 - €80,000
Clinical Document Management Specialist">

The Clinical Document Management Specialist is responsible for the delivery and oversight of clinical document authoring, formatting, compilation, and publishing required for regulatory submissions. This role requires collaboration with cross-functional stakeholders to plan, prepare, and deliver high-quality documents within timelines.

Key Responsibilities:
  • Coordinate and manage clinical document workflows to ensure timely and accurate submissions to health authorities.
  • Develop and maintain submission readiness processes to improve efficiency and quality.
  • Collaborate with regulatory writing and submissions teams to ensure compliance with health authority guidelines and good documentation practices.
  • Identify and communicate processing risks and trends related to clinical documents and work with key stakeholders to define and implement remediations.
  • Serve as a subject matter expert on clinical document management training materials and tracking tools.
  • Provide audit and inspection support and contribute to root cause analysis identification and creation/delivery of corrective action plans.
Required Skills and Qualifications:
  • Bachelor's degree in life sciences, healthcare, pharmacy, or information management and relevant industry experience.
  • English fluency (written, oral) required.
  • Thorough knowledge of clinical document management processes.
  • Advanced knowledge of clinical documentation practice guidelines and principles.
  • Experience in authoring, compilation, and formatting of clinical documents according to ICH E3.
  • 3-5 years in clinical development or clinical operations or similar business area.
  • 2-3 years working experience with document management systems and excellent understanding of system structures and generic document management functionality.
  • Good understanding of technical processes and PC environment including Microsoft suite of products.
  • Advanced ability to work independently.
  • Experience with project work or project management in a global, cross-functional multicultural and international matrix organization.
  • Excellent communication, organization, and tracking skills.

This role requires a proactive and innovative approach to managing complex clinical document workflows. If you have a strong background in clinical document management and are looking for a challenging opportunity, we encourage you to apply.

Clinical Document Management Specialist

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