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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.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in regulatory publishing and submission delivery, ensuring eCTD compliance and adherence to global regulatory requirements. Capable of leading projects, driving process improvements, and fostering capability development through training and mentoring.
Highest-signal resume keywords
Regulatory PublishingECTD ComplianceDossier CompilationGlobal Regulatory RequirementsStakeholder Engagement
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory SubmissionDossier CompilationECTDNeeSTechnical ValidationQuality ControlProcess ImprovementGxP StandardsDocument ManagementPharmaceutical Industry Experience
Soft Skills
Communication SkillsStakeholder EngagementMentoringTrainingCollaboration
Tools & Technologies
Automation SystemsEmerging Technologies
Industry Keywords
Health Authority RequirementsEMAFDAICHElectronic Documentation Standards
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