Novo Nordisk

Technical CMC Writers / Regulatory Writers - TIDES and Small Molecules

Fuldtid

Permanent

Gladsaxe

SE PÅ KORT

ID: 2590708

Indrykket for 21 dage siden

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.

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