Sr Publisher I II

Company:Novo Nordisk Global Business Services (GBS)

Shape how life-changing therapies reach patients around the world. As a Sr Publisher youll drive the regulatory publishing and submission delivery that turns scientific breakthroughs into approved medicines and youll do it with a level of independence influence and impact that few publishing roles can match.

Your new role
As a Sr Publisher I/II you will independently drive regulatory publishing and submission delivery for marketing applications and lifecycle management activities both regional and global. You will ensure eCTD compliance in accordance with Health Authority requirements while acting as a subject matter expert and lead publisher on assigned projects.

Your key responsibilities will include:

• Leading the planning compilation publishing technical validation and timely dispatch of regulatory submissions including MAAs NDAs and post-approval change submissions in line with country-specific requirements
• Driving publishing and compilation of clinical non-clinical and safety documents ensuring adherence to approved templates style guides timelines and publishing standards
• Acting as the lead publisher for assigned projects/products serving as the primary stakeholder contact and driving end-to-end publishing activities to ensure submission readiness
• Performing and overseeing electronic quality control (eQC) of published documents intended for regulatory submissions
• Driving process improvement and optimisation initiatives to enhance publishing efficiency quality and compliance including the development of SOPs templates and best practices
• Strengthening capability development through onboarding training mentoring and structured knowledge sharing across the publishing team
• Driving inspection readiness ensuring adherence to GxP standards and proactively identifying compliance risks

Your new department
In Research & Development youll be part of a unit that explores bold scientific ideas and advances them into clinical testing. We combine curiosity AI tools and human data to develop transformative therapies. Through collaboration and operational excellence we shape and deliver an innovative pipeline to meet future patient needs.

Within R&D our regulatory publishing team plays a critical role in translating scientific progress into approved therapies for patients worldwide. We are a highly collaborative globally connected team working closely with regulatory affairs clinical safety and non-clinical colleagues to deliver compliant high-quality submissions to health authorities across the globe. Your work here will directly enable Novo Nordisk to bring new treatments to patients faster.

Your skills & qualifications
We are looking for a highly experienced publishing professional who combines deep technical expertise with a proactive quality-driven mindset. To succeed in this role youll bring:

• A bachelors or masters 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 including experience supporting EU regulatory submissions
• Solid experience in dossier compilation and publishing using eCTD NeeS and standard submission formats as well as working with Document Management Systems and regulatory publishing systems
• Thorough knowledge of global regulatory requirements including EMA FDA ICH and other applicable electronic documentation standards
• Strong stakeholder engagement and communication skills with the ability to influence alignment across global cross-functional teams
• A digital and innovation mindset comfortable leveraging systems automation and emerging technologies (including AI) to optimise publishing processes
• Fluency in English coupled with accountability attention to detail and the ability to work with a high degree of independence

Working at Novo Nordisk
Every day we seek the solutions that defeat serious chronic diseases. To do this we approach our work with determination constant curiosity and a commitment to finding better ways forward. For over 100 years this dedication has driven us to build a company focused on lasting change for long-term health. One where diverse thinking shared purpose and mutual respect come together to create extraordinary results. When you join us youre not just starting a job youre becoming part of a story that spans generations.

What we offer
There is of course more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means opportunities to learn and develop are all around us while our benefits are designed with your career and life stage in mind.

Deadline

17 July 2026. Applications are reviewed on an ongoing basis so please apply as soon as possible.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk were not chasing quick fixes were creating lasting change for long-term health. For over 100 years weve been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of whats possible in healthcare. We embrace diverse perspectives seek out bold ideas and build partnerships rooted in shared purpose. Together were making healthcare more accessible treating and preventing diseases and pioneering solutions that create change spanning generations. When you join us you become part of something bigger a legacy of impact that reaches far beyond today.