Senior Clinical Documentation Coordinator - DS24-13657

Position: Senior Clinical Documentation Coordinator
Location: Lansdale, PA (Hybrid)
Duration: 2 months

Job Overview:
The Senior Documentation Coordinator will oversee the management and organization of procedural documents, offering guidance on documentation strategies within the Global Regulatory Affairs and Clinical Safety (GRACS) department. The role also involves close collaboration with cross-functional teams to ensure that the documentation accurately reflects current processes and adheres to regulatory requirements.

Key Responsibilities:

• Manage the lifecycle of procedural documents, from development through to approval and final implementation, ensuring they meet organizational standards.
• Lead assessments to determine the impact of process updates across the full document library, providing insights to streamline the revision process.
• Collaborate with team leads and subject matter experts to create and update process flows that support efficient documentation development.
• Ensure the documentation is regularly reviewed and updated to align with organizational standards for format, structure, and style.
• Facilitate the smooth execution of documentation revisions by supporting change control systems and ensuring timely access for team members.
• Coordinate document retrieval and management requests for internal audits and compliance reviews.

Qualifications:

• Bachelor's degree or higher.
• At least 6 years of relevant industry experience with a focus on procedural documentation within regulatory or safety functions.
• Strong understanding of managing documentation for regulatory or pharmacovigilance processes.
• Familiarity with content organization and control systems for ease of access and retrieval.
• Preferred experience with Veeva Vault or similar document management tools.