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stillingsbetegnelse:
Chemist/regulatory writer in Manufacturing Development

jobbeskrivelse:

Are you structured by nature and do you have preference for serving an argumentation based on solid facts and high level of details? And are you capable of balancing detail oriented preference with the need for you to keep alignment with the overall strategy? Then you may be our new chemist with focus on regulatory writing.

 

About the department

45 competent employees organised in four teams make up Biopharm Manufacturing Development, API Support. We provide support to the API processes within Novo Nordisk’s Biopharm portfolio of Haemophilia products, Norditropin® and GlucaGen®. The department serves as a link between development and production and is involved in the exciting new and marketed products in Biopharm.

 

The position

An essential part of our department tasks is our responsibility for regulatory documentation related to the process and the products. This involves maintaining and updating regulatory files for marketed products. Furthermore, writing the documentation for submission for approval of new products within API/Drug Substance is a key part of expanding our product portfolio.

One of your main objectives in this position is to take part in the regulatory documentation and ensuring filing documents of a high quality that are aligned with the demands from Regulatory Affairs and the authorities. It is important that you have a keen eye for details as a substantial part of the position will involve writing, cross checking and reviewing documents before submission. In addition, you are expected to show drive and a can do attitude to ensure that deadlines and commitments are meet.

You will be part of a product team and therefore communication and collaboration is of key importance to ensure efficient distribution of tasks and alignment across the team and the department. Furthermore, you are expected to build and maintain a good relation to your wide range of stakeholders e.g. the production departments, Quality Assurance, R&D, Regulatory Affairs, senior management groups, analytical departments and project groups. 

This is a 24 month temporary position with the possibility of permanent employment.

 

Qualifications

As we are looking for a chemist/regulatory writer, we are expecting you to hold a MSc in e.g. Engineering, Pharmacy or a similar field. You have a proven record of 3+ years experience from working under GMP requirements and are familiar with the current industry standards for process validation and regulatory standards for documentation. You have a systematic and structured approach to working with data and sound communication skills in Danish and English enabling you to document your work accordingly. Besides, you can effortlessly collaborate with colleagues from various backgrounds. Finally, you have an eye for quality and manage to prioritise your work to meet every deadline.

 

Working at Novo Nordisk

At Novo Nordisk, your skills, dedication, and ambitions help us change lives for the better. In exchange, we offer unique possibilities for professional and scientific development in an informal working environment, and the chance to integrate into a dynamic team of highly qualified and enthusiastic colleagues.

 

Contact

For further information, please contact Alexander Hildenbrand on +45 30793630

 

Deadline

23-11-2018

 

Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C2113

abstractJV_contact_0: Please apply using one of the specified channels

positionTypeCode: directhire

contractTypeCodes_0: fulltime

Arbejdsgiver Navn: Novo Nordisk A/S

source: DK-STAR