The PositionDevelops 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.
RelationshipThis 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 RequirementsApproximately 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.
