The Patient Narrative Coordinator supports the Patient Narrative Project Lead by coordinating the end-to-end process for patient narratives (PNs) ensuring timely delivery, quality, and regulatory compliance.  The role requires strong project management, cross-functional collaboration, and effective oversight of external vendors throughout the PN development lifecycle.

Key Responsibilities:

• Project Management:
  • Support the development, monitoring, and adaptation of project plans and timelines for Patient Narrative (PN) projects.
  • Assist in driving the PN process, ensuring timely and successful finalization of documents and final delivery.
  • Manage timelines and deliverables across internal teams and external vendors under the direction of the Patient Narrative Project Lead.

• Coordination and Collaboration:
  • Facilitate proactive and continuous cross-functional coordination with Biostatistics and Data Sciences, Pharmacovigilance, Regulatory Affairs, and other stakeholders
  • Collaborate with external vendors or CROs to resolve issues and to ensure on-time delivery.
  • Serve as the interface to Boehringer Ingelheim systems that are not accessible to external vendors.

• Quality Evaluation:
  • Ensure vendor deliverables meet established criteria via review of PNs to ensure completeness, accuracy, scientific content, and adherence to template, project standards, and regulatory requirements

• Document Management:
  • Set up and maintain files using project SharePoints and the document management system.
• The job involves working in global, cross-functional study and project teams, coordinating, and supervising a time-sensitive technical process with cross-functional involvement. Additional complexity is introduced by external providers and awareness of cultural diversity. The job requires handling numerous complex tasks simultaneously.

• Sound knowledge of document management systems, clinical documents standards, clinical trials, their documentation, and regulatory requirements. Deep knowledge of international writing standards and conventions and regulatory writing. Sound knowledge of safety reporting and regulatory requirements. Ability to proactively identify problems and initiate improvements. Understanding of the business impact of timelines for clinical documents.

• Excellent written and verbal English skills, sound knowledge of MS Office (especially Word, Adobe), Microsoft 365, document management systems, and high IT affinity. Places a high priority on regulatory compliance and quality. Ability to manage projects effectively across regions and in matrix environments, including time management and oversight of external providers. Ability to manage parallel tasks and variable workload. Strong interpersonal and social skills, ability to communicate effectively in international cross-functional teams, cultural sensitivity.
• Master’s degree with a minimum of 2-3 years or a bachelor’s degree with a minimum of 3-5 years of working experience, preferably in e.g. natural sciences, pharmacy, medicine or digital technologies, project management or communication science or any other relevant field with at least 3 years of professional experience preferably in clinical operations or related areas; alternatively vocational training, associate’s degree, technical college e.g. in medical documentation or other relevant fields, with at least 5-8 years of professional experience and preferably 3 years of experience in technical writing, clinical operations or related areas.