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Regulatory Documentation Specialist
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Odense, Odense Kommune, Denmark Novo Nordisk AS Full timeAbout this roleWe are seeking a highly skilled Technical Writer to join our Operation Readiness team at Novo Nordisk. The ideal candidate will be responsible for developing training plans, standard operational procedures, job instructions, risk management, regulatory impact assessments, and implementation plans.Key responsibilitiesSupport the development and...
Technical Writer
2 months ago
We are seeking a highly skilled Technical Writer to join our Operation Readiness team at Novo Nordisk. As a key member of our team, you will play a crucial role in ensuring our products meet the highest standards of regulatory compliance and document management.
Key Responsibilities- Develop and Maintain Documentation: Create and update technical documents, including training plans, standard operational procedures, job instructions, and risk management plans, to ensure compliance with regulatory requirements.
- Support Process Validation: Collaborate with cross-functional teams to execute and coordinate validation of processes and projects, ensuring that all documentation meets regulatory standards.
- Regulatory Compliance: Provide expertise on regulatory requirements and ensure that all documentation is compliant with applicable regulations.
- Document Management: Oversee the development and maintenance of documentation, ensuring that it is accurate, up-to-date, and easily accessible.
- Process Improvement: Identify areas for improvement and implement changes to optimize processes and documentation.
- Collaboration and Communication: Work closely with quality and other departments to achieve optimal solutions and ensure effective communication across the organization.
- Education: BSc/MSc education in a natural or technical science, such as mechanical, manufacturing engineer, or related field.
- Experience: 2 years of experience in the pharmaceutical or biotechnology industry, with a focus on document management and regulatory compliance.
- Skills: Good communication skills, ability to create transparency for colleagues, and experience working within a production area and familiarity with electronic records.
Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. We are committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve, and the communities we operate in.
