CMC Drug Development Submission Specialist
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Søborg
Are you interested in being a key contributor within Chemistry, Manufacturing & Control (CMC) in the process of preparing successful drug registrations at Novo Nordisk? Do you enjoy the opportunity of discussing strategies, storylines and reviewing/writing regulatory CMC documents in multi-disciplinary teams? Do you have a strong scientific basis within CMC development processes across major parts of the entire CMC value chain from manufacturing of the active pharmaceutical ingredient to the final released drug product? Then this job may be just the right career move for you. Come join us, apply today!The Position As CMC Drug Development Submission Specialist you will work as a partner to the CMC Project Directors in the planning and preparation of the Quality section of the registration file, as well as participating in the Q&A process with the Health Authorities. These tasks will typically take place in close collaboration with CMC submission team members, authors of individual CMC documents, and project managers from Regulatory Affairs, CMC, Product Supply and Device.Your key responsibilities include reviewing the whole Quality section of new drug applications for compliance and consistency, preparing selected documents managing relevant training activities of authors. Furthermore, you will participate in planning and preparation of the overall document structure of the Quality section, as well as contribute to the establishment of detailed storylines for individual documents. You are also expected to contribute to knowledge sharing within the CMC organisation based on the feedback from Health Authorities.Qualifications You hold a Master or PhD degree within a relevant field of scientific expertise such as Chemistry, Chemical Engineering, Pharmacy, Biology or similar.You possess solid knowledge (preferably at a specialist level) of the CMC value chain, as well as drug development and regulatory requirements.As a person you: have experience within the scientific field of active pharmaceutical ingredient manufacturing process development
have experience with manufacturing development of drug products (incl. formulation and filling), product characterisation and analytical method development
have several years of experience with contribution to regulatory submissions (FDA, EMA and ideally PMDA and NMPA-CDE), including preparing documents for the Quality section.
This has provided you with a thorough understanding of regulatory processes and requirements and sharpened your skills within scientific writing in English.
master the combination of technical insight, quality focus, and good communication, and you can see the potential of being a true expert in this specific area of expertise.
pay high attention to details to secure consistency and alignment across written documentation
are a team player with the ability to work independently.
possess excellent collaboration skills combined with a structured way of working, and with a good sense of humor.
Lastly, you are fully proficient in both written and spoken English.About the CVP area and department The position is anchored in CMC Portfolio Management, which is a central part in CMC Development & Scaling. We are responsible for planning and managing the CMC part of the entire Novo Nordisk portfolio of development projects. This includes preparation of CMC documentation for submission to Health Authorities, where we support the registration phase of new medicinal products, including planning and execution of the different stages and elements of the entire registration process.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 For questions, please contact Principal CMC Submission Specialist Ann-Kristin Bentsen at: +45 3079 7532 or VP of Rare Disease and Advanced Therapies Henrik Nordstrøm Ferré, at: +45 3075 7882.Deadline15th January 2024.Interviews will be conducted on an ongoing basis, so please apply today.You do not need to attach a cover letter to your application, but please include a few lines about your motivation in your resume or CV. In addition, please avoid the use of photos in your CV. This makes for a better and more fair process. 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.
This has provided you with a thorough understanding of regulatory processes and requirements and sharpened your skills within scientific writing in English.
Information og data
Denne ledige stilling har jobtypen "Projektleder", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 13.12.2023, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Projektleder
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