Regulatory Content Specialist (Denmark, Søborg)

Jobbeskrivelse
Placering
Søborg, Denmark

Jobkategori
Clinical Development

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Are you an experienced Medical Writer looking for possibilities to grow your career further and apply your competencies in a global healthcare company? If yes, then we would love to hear from you.

At Novo Nordisk, we have a passion for improving patients’ lives all over the world. If you want to help us bring this passion to life, while further developing your expertise within scientific communication and act as an integral part of impactful agile teams, please apply and become the newest member of our Content Management Team in Clinical Reporting. In the role as a Regulatory Content Specialist you will work as a strategic partner in a dynamic environment to bring groundbreaking treatments to patients worldwide.

The position
As a Regulatory Content Specialist in the Content Management Team, you will be an integral part of supporting the operational implementation of our digital product, NovoScribe, which has been developed to produce clinical study reports (CSRs). NovoScribe is an automated authoring platform developed using a structured authoring approach and GenAI. It fosters a standardized, validated, and methodical approach to document creation and it utilizes automated integration of statistical results by incorporating systematic tagging and topic-based authoring. The aim of NovoScribe is to transform the way we write documents (eg. clinical study reports) by introducing automation and GenAI. You will be working in a transformative and innovative team, which is leading the pharmaceutical industry in automated document creation. Your key responsibilities include:

• Serve as an informal leader and subject matter expert for document automation initiatives across the organization and maintain oversight of CSR plans and timelines across the team
• Guide and mentor colleagues in adopting new document automation tools and methodologies
• Lead by example in championing digital transformation in clinical and regulatory documentation processes and collaborate on the development of regulatory content following established guidelines and SOPs
• Evaluate documents for coherence, precision, scientific rigor, and consistent information and messaging and maintain the text library in the database and expand it to include more disease areas
• Provide input to the improvement of the database and play a pivotal role in functional and cross-functional teams
• Actively engage in improving best practices and innovating the way we work across areas and maintain an updated understanding of essential regulatory, scientific, and medical subjects pertinent to drug development, designated products, and specific disease/therapeutic domains
• Mentoring and training other regulatory content writers and medical writers, and be responsible for the document quality in your team, as well as your own documents

As a Regulatory Content Specialist, you will be an integral part of the team that is leading the way in automated document creation. You will have the opportunity to contribute to the transformation of the way we write documents in the pharmaceutical industry by actively engaging in improving best practices and innovating the way we work. We are globally oriented, and as a Regulatory Content Writing Specialist, you will work in close collaboration with colleagues in cross-functional teams in both Denmark and abroad.

The position is office-based in Søborg, Denmark.

Qualifications
You have a master’s degree within natural sciences (MSc., MSc. Pharm. or equivalent), preferably supplemented with a PhD and/or relevant experience in the pharmaceutical industry and you have solid experience within:

• Demonstrated ability to produce clear, high-quality scientific writing in the English language
• Experience of authoring clinical study reports (CSRs) and using and maintaining databases
• Ability to work effectively on cross-functional, geographically diverse teams, establishes strong collaborative relationships; track record of successfully advocating for and implementing change
• A track-record of driving your own complex tasks from start to end, navigating many different stakeholders
• Demonstrate your ability to improve processes and to drive adoption of new technologies or processes across teams
• A high level of expertise in communicating scientific information, with the ability to tailor such information to meet diverse objectives; you have expert understanding of clinical development, regulatory processes & requirements and clinical documents

You are an excellent communicator who thrives in fast-paced environments, adapts quickly to change, and consistently meets tight deadlines. With strong strategic thinking, proactive planning, and coordination skills, you drive and engage teams effectively and manage diverse stakeholders with ease. Pragmatic and structured, you're not afraid to challenge the status quo, and your collaborative spirit, positive attitude, and sense of humor help foster a supportive and engaging work culture

About the department
You will join us in Clinical Reporting, the medical writing function at Novo Nordisk – currently comprising around 150 medical writers worldwide. We are part of Novo Nordisk Development and anchored in the Submission & Life Cycle Management area. Development is responsible for managing clinical drug development and submissions to health authorities worldwide, from the early development phases to market authorisation. Our supportive culture drives business transformation and we value continuous learning, being bold and striving for simplicity.

Clinical Reporting covers all clinical drug development projects across therapy areas. Our main focus is to use our scientific expertise to drive clear and impactful communication on the conduct and outcome of clinical trials and our main task is to communicate clinical data in a clear and concise manner.

Working at Novo Nordisk
Founded in Denmark in 1923, Novo Nordisk has become one of the world’s leading healthcare companies. At Novo Nordisk, we are committed to driving change to defeat diabetes and other serious chronic diseases. To fulfil this purpose, we pioneer scientific breakthroughs, expand access to our medicines, and work to prevent and ultimately cure disease. That said, we are anything but linear. With us, your skills, commitment, and ambition help us change patients’ lives worldwide. In exchange, we offer you a rewarding and purpose-driven culture with talented and diverse co-workers. Therefore, your professional and personal development is essential for us, and in Novo Nordisk, the sky is the limit for career opportunities.

Contact
For further information, please contact Inger Ødum Nielsen, Team Lead in Content Management Team, Content Digitalisation, on 45 30795567

Deadline
8 May 2025

You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.

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

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.