Senior GxP Compliance & Patient Safety Technical Writing Manager

Facility:
Quality

Location:

Plainsboro, NJ, US

The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient centered focus.

At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We’re changing lives for a living. Are you ready to make a difference?

Develops procedural documentation in a GxP environment, ensuring compliance and operational effectiveness, while also creating and writing content for training materials and developing job aids. Conducts electronic document management system (EDMS) administration through the routing of documents for review and approval workflows, managing periodic review cycles and maintaining accurate document metadata. Supports activities related to deviations and corrective actions impacting relevant processes.

Supports and maintains inspection readiness for the GxP Compliance and Patient Safety Training team.

This job reports to the Director of GxP Compliance & Patient Safety Training. This job will interact with Patient Safety, Quality, Vendor and Contract Management, IT, Finance, Contract/Supplier of Customer Engagement Programs and other CMR

Functional area

s.

• SME for writing and updating standard operating procedures (SOPs) and supporting documents
• Execute routine workflows for document management systems, such as Quality Docs
• Support ongoing inspection readiness efforts and provide support during audits
• Assists in the closure of CAPAs, deviations and other quality activities
• Key Area #1:
  Process & Document Creation
  • Develop and maintain procedures and supporting documents (e.g., SOPs, work instructions and job aids), incorporating input from Patient Safety leadership and relevant Subject Matter Experts (SMEs)
  • Ensure GxP processes and related documentation adhere to regulatory requirements, support corporate compliance and are inspection ready
  • Create and write supporting content for training programs, including user-friendly job aids that support process understanding and application
  • Support the development and maintenance of GxP process flows
• Key Area #2:
  System Administration
  • Execute routine workflows for electronic document management via Veeva Vault Quality Docs
  • Prepare documents for review and approval workflows in Quality Docs, ensuring an audit trail is maintained, and electronic signatures are received from relevant stakeholders on time
  • Execute routine GxP document maintenance through periodic review cycles
• Key Area #3:
  Inspection Readiness & Audit Support
  • Support compliance and audit/inspection readiness strategies and plans, ensuring all documentation meets necessary standards
  • Ensure controlled documentation (including vendor training procedures and records) is accurately maintained, versioned and audit ready
  • Provide validated reports from Quality Docs, when requested, in support of audits and inspections

Approximately 10% overnight travel.

• A bachelor’s degree in Communications, Medical or Science-related discipline required; relevant experience may be substituted for degree
• 7+ years progressive responsibility experience in relevant pharmaceutical industry
• Experience in process development, delivery and/or…