Technical CMC Writers / Regulatory Writers - TIDES and Small Molecules (Denmark, Bagsværd)

Jobbeskrivelse
Placering
Bagsværd, Denmark

Jobkategori
Manufacturing

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Are you passionate about technical writing (incl. IP) and/or regulatory submission process and the subsequent Q&A process? Do you have experience from working with API manufacturing processes and/or the regulatory field? We are looking for a new colleague to join a team that set the standards for technical writing and/or regulatory submission documents for Novo Nordisk growing pipeline of project based on chemically manufactured APIs and synthetic manufacturing platform.

Apply now and start your new journey!

Get introduced to Emerging Technologies API Manufacturing Development (ET API MDev) - a part of CMC Chemical Development - and meet some of our great employees by visiting our career site

The position
As a Regulatory Writer (seniority level depends on candidate experience), it will be your responsibility to define the regulatory storyline in collaboration with Regulatory Affairs.

• You will create documentation for our portfolio of products (TIDES and Small Molecules) to ensure that the required product quality is fulfilled and thereby secure the safety of our patients.
• You will write and review regulatory submission documents related to manufacturing processes of chemically synthesized API’s. Our regulatory submissions cover health authorities across the globe, and you will also take part in the process of answering questions from health authorities related to our submission.
• You will do all of this and more in cooperation with colleagues in your new department, Emerging Technologies API Manufacturing Development.
• Also, you will collaborate with colleagues from other parts of CMC, quality control, quality assurance, contract manufacturing organizations and regulatory affairs.

You will take part in shaping the way we write our regulatory documents based on continuous learnings and feedback, and you will be a part of a Regulatory Writer Network across functions in Novo Nordisk. As a Technical CMC writer (preferably in a combined role with regulatory writer), it will be your responsibility to provide clear and concise technical reporting of internal CMC/process documentation of developments made internally or at our external collaborators. Drafting source documents for process patents and regulatory documentation could also be a part of this role.

Qualifications
To succeed in this role, you have:

• An academic degree in Science within Pharmacy, Chemistry, Engineering, or a similar field.
• Experience either from the pharmaceutical industry, the regulatory area or from the health authorities with either writing or reviewing regulatory documents is a strong advantage.
• A passion for communication; Spoken and written (full professional proficiency).
• (Ideally) experience of working with chemical manufacturing of API’s.
• Excellent ability to plan and coordinate the writing work in line with an ambitious submission strategy.
• Knowledge of IPR and process patents is a strong advantage

On a personal note, you have a structured and detail-oriented approach to everything you do. You take pride in delivering high quality documents and to do so you build and create a network across Novo Nordisk to improve your knowledge and skills. We are establishing our technical and/or regulatory writer function within the department. The right candidate shares our view that the whole is greater than the sum of the individual parts as we believe that teamwork divides the task but doubles the success.

About the department
As part of Novo Nordisk’s Product Supply organization, you will be assigned to Emerging Technologies API Manufacturing Development (ET API MDev), a cross-functional area currently being established within CMC area. We work at the interface between CMC and full-scale manufacturing with a focus on process understanding, implementation, optimization, and life cycle management. We offer a very interesting and varying job with the opportunity to work with other highly qualified and motivated colleagues in a multidisciplinary project environment.

Working at Novo Nordisk
At Novo Nordisk, we don’t wait for a change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development to manufacturing, marketing, and sales – we’re all working to move the needle on patient care.

Contact
For further information, please contact Hao Jiang at +45 3448 4222.

Deadline
May 26th, 2024. Applications are reviewed on an ongoing basis, so please submit your application as soon as possible.

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 process, please refrain from adding a photo to 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.