Job Description

Are you passionate about clinical science and regulatory submissions? Do you have the expertise and drive to lead the preparation of high-quality clinical documents and strategies for regulatory approval in Japan? If so, we invite you to bring your skills and experience to Novo Nordisk and make a difference in the lives of patients worldwide. Read on and apply today!

About the department

Novo Nordisk is a global healthcare company with over 100 years of innovation in diabetes care. This heritage has equipped us to help people defeat obesity, haemophilia, growth disorders, and other serious chronic diseases. Headquartered in Denmark, Novo Nordisk employs over 77,000 people in 80 offices and markets our products in more than 170 countries.

You will join the Development & Project Leadership team based in Tokyo, Japan. Our mission is to formulate and implement sophisticated development strategies and clinical documents to achieve the earliest regulatory approval in Japan. We work closely with global Medical Writers and stakeholders to prepare PMDA meeting packages and J-CTDs, ensuring alignment and excellence in our submissions. The atmosphere in our department is dynamic, collaborative, and focused on optimising processes and sharing best practices. We are committed to fostering a culture of knowledge sharing, simplicity, and innovation, where every team member can contribute to making a meaningful impact.

The position
As a Senior Clinical Scientist, you will play a pivotal role in ensuring the success of clinical development and regulatory submissions in Japan. Your key responsibilities will include:

• Translating and reviewing documents, including PMDA meeting packages and J-CTD, with a focus on accuracy and quality.
• Leading the preparation of PMDA meeting packages and responses to inquiries, including proposing development and regulatory strategies in collaboration with global stakeholders.
• Preparing and reviewing clinical sections of the Japanese Common Technical Document (J-CTD) for submission, ensuring consistency and quality.
• Acting as a mentor and trainer for other Clinical Scientists, contributing to the development of the team.
• Managing multiple tasks simultaneously within challenging timelines while maintaining high standards of quality.

Qualifications

• University degree (master’s preferred) with experience as a Medical Writer or in a similar role, including preparation of CTDs and responses to inquiries in applications for 7 or more drug products for over 7 years.
• Expert knowledge of medical writing, drug development, regulatory processes, and relevant regulations, with strong Japanese writing skills to create CTDs and responses to inquiries.
• Proficient in English, including the ability to converse, read, and write, and capable of holding meetings with headquarters via Teams while providing explanations and discussions in English.
• Independent worker with strong analytical skills, commitment to accountability, and the ability to manage multiple tasks effectively while remaining results-driven and goal-oriented.
• Excellent communication and presentation skills, a collaborative team player who is open and honest, capable of sharing knowledge and providing support and training, and possesses strong leadership and negotiation abilities.

Working at Novo Nordisk
We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energize us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease.

Contact
Upload your CV to our online career page (click on Apply and follow the instructions).

Deadline
Until the completion of recruitment.
Applications will be screened on an ongoing basis, so you are encouraged to apply as soon as possible.

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.

#LI-AMS1

Job Tags

Similar Jobs