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Senior Publisher I/II
Novo NordiskSr Publisher driving regulatory publishing and submission delivery for marketing applications and lifecycle management at Novo Nordisk. Ensuring eCTD compliance and leading publishing efforts for successful submissions.
About the role
Key responsibilities & impact- Independently drive regulatory publishing and submission delivery for marketing applications and lifecycle management activities
- Ensure eCTD compliance in accordance with Health Authority requirements
- Lead the planning, compilation, publishing, technical validation, and timely dispatch of regulatory submissions
- Drive publishing and compilation of clinical, non-clinical and safety documents
- Act as the lead publisher for assigned projects/products
- Perform and oversee electronic quality control (eQC) of published documents
- Drive process improvement and optimisation initiatives
- Strengthen capability development through onboarding, training, mentoring and structured knowledge sharing
- Drive inspection readiness and ensure adherence to GxP standards
Requirements
What you’ll need- A bachelor's or master's degree in pharmacy, science or a related field (advanced degree preferred)
- Minimum 6-7 years of relevant experience in the pharmaceutical industry within document and regulatory publishing
- Solid experience in dossier compilation and publishing using eCTD, NeeS and standard submission formats
- Thorough knowledge of global regulatory requirements including EMA, FDA, ICH and other applicable electronic documentation standards
- Strong stakeholder engagement and communication skills
- A digital and innovation mindset, comfortable leveraging systems, automation and emerging technologies
- Fluency in English.
Benefits
Comp & perks- Opportunities to learn and develop
- Health insurance
ATS Keywords
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Hard Skills & Tools
Regulatory SubmissionDossier CompilationECTDNeeSTechnical ValidationQuality ControlProcess ImprovementGxP StandardsDocument ManagementPharmaceutical Industry Experience
Soft Skills
Communication SkillsStakeholder EngagementMentoringTrainingCollaboration