Senior GxP Compliance & Patient Safety Technical Writing Manager

About the Department

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?

The Position

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.

Relationship

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 areas.

Essential Functions

• SME for writing and updating standard operating procedures (SOPs) and supporting documents
• Execute routine workflows for document management systems, such as QualityDocs
• 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 VeevaVault QualityDocs
  • Prepare documents for review and approval workflows in QualityDocs, 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 QualityDocs, when requested, in support of audits and inspections

Physical Requirements

Approximately 10% overnight travel.

Qualifications

• 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 implementation is preferred, including the creation of training content and job aids
• GxP environment experience required; pharmacovigilance (PV) experience preferred, with knowledge of medical terminology
• Excellent presentation, interpersonal and stakeholder management and coaching skills and demonstrated ability to collaborate with cross-functional stakeholders
• High proficiency in PowerPoint, Word, Outlook and Excel
• High proficiency in AI and other documentation software and platforms
• Demonstrated skills in Visio and other flowchart software
• Strong project management skills with abilities to manage multiple projects

The base compensation range for this position is $120,300 to $185,000. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance. Novo Nordisk offers long-term incentive compensation and or company vehicles depending on the position's level or other company factors.

Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy and parental leave policy.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.