Scientist for regulatory document writing

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Måløv

Are you passionate about the regulatory submission process and writing? Do you have experience from working within the analytical or regulatory field? And can you gather important cross-functional knowledge and ensure regulatory alignment across the team? Then you are the new Regulatory Writer, we are looking for. The position In Drug Product Development Project Office, we are responsible for the analytical and drug product development for both early and late phase clinical trials, submission and much more. It will be your responsibility to define the regulatory storyline and create documentation for our portfolio of products to ensure that the required product quality is achieved and consequently secure the safety of our patients. You will:
  • write and review regulatory submission documents such as CTA (Clinical Trial Applications) and marketing applications related to the analytical field
  • take part in the process of answering questions from health authorities across the globe related to our submissions
  • collaborate with colleagues from other parts of CMC and manufacturing development, quality assurance and regulatory affairs
  • take part in giving content to the way we write our regulatory documents based on continuous learnings and feedback
    • To succeed in this role, you will take ownership and have a proactive approach and close cooperation with colleagues in the Project Office, ensure the regulatory setup and documentation is in order and that required product quality is achieved. Qualifications We are currently looking for a colleague with experience within the regulatory or analytical field as well as a Master’s degree within Pharmacy, Chemistry, Engineering, or a similar field. Furthermore, you have:
  • a passion for writing with full professional proficiency in English
  • experience either from the pharmaceutical industry, the regulatory area or from the health authorities with either writing or reviewing regulatory documents
  • excellent skills at creating an overview and prioritizing your tasks
  • good at communicating and conveying regulatory information
    • 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 to improve your knowledge and skills. On a personal note, you are open-minded, enjoy sparring and great colleagueship. The department As part of Novo Nordisk’s Product Supply organization, CMC Development makes a real difference for patients with chronic diseases across the world. We develop, manufacture, and distribute drug candidates for non-clinical and clinical trials which is a complicated journey that requires about 10 years of dedicated work in CMC Development. Your new department, CMC Drug Product Development - Project Office, consists of 30 employees located in Måløv. The department is involved in early and late-stage drug product development, analytical development and chemical and biological characterization of new entities moving through the clinical phases of drug product development. Working at Novo Nordisk At Novo Nordisk, we don’t wait for 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, through to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. Contact If you have any questions about the job, please contact Associate Manager, Susie Jelsbak Christensen at +45 30775028. Deadline 16th August 2023 You do not need to attach a cover letter to your application, but please include a few sentences in your resume or CV about why you are applying for the job. To ensure an efficient and fair recruitment 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.


    Information og data

    Denne ledige stilling har jobtypen "Forretningsudvikler", og befinder sig i kategorien "Kommunikation, marketing, salg".

    Arbejdsstedet er beliggende i Måløv.

    Jobbet er oprettet på vores service den 12.7.2023, men kan have været deaktiveret og genaktiveret igen.

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