Arbejde CMC Submission Specialist Hovedstaden Novo Nordisk A/S - jobtilbud

GÆLDER
stillingsbetegnelse: CMC Submission Specialist

jobbeskrivelse:
- Drug Development - Denmark - Bagsværd Are you interested in being a key CMC participant in the process of preparing successful drug registrations at Novo Nordisk? Do you enjoy providing input to and reviewing/writing regulatory CMC documents in multi-disciplinary teams? Do you have a strong basis within CMC development processes? Then we are definitely interested in hearing from you. About the department By joining the CMC submission specialist team you will be part of CMC Project Planning and Management, a central unit in CMC Supply with the responsibility of planning and managing the CMC part of the entire Novo Nordisk portfolio of development projects. This includes preparing of CMC documentation for submission to Health Authorities. The CMC submission specialist team consists of three experienced specialists. We support CMC project managers and CMC project teams throughout the registration phase of new medicinal products. We work together to coordinate, write, and review CMC documents as required by regulatory authorities worldwide. As we work in a rapidly changing regulatory landscape, knowledge sharing across the CMC development organisation is a main responsibility of the CMC submission specialist team. The job As CMC submission specialist positioned within the development organisation, you will as partner to the CMC project managers be responsible for contributing to the planning and execution of the different stages and elements of the entire registration process. You will typically work in close collaboration with CMC project managers, CMC project team members, authors of individual CMC documents, and project managers from Regulatory Affairs. Your key responsibilities include reviewing the whole Quality section of new drug submissions for compliance and consistency, as well as preparing selected documents. Furthermore, you will be managing training activities related to planning and preparation of the Quality section of the registration file. You are also expected to secure that learnings from the feedback of Health Authorities is implemented in the organisation as appropriate. Qualifications Your background is a degree at minimum MSc level (in pharmacy, biochemistry, engineering or similar). You are highly experienced within CMC development, preferably at a specialist level. In addition to this, you have several years of experience with contribution to regulatory submissions, 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. You like the combination of technical insight, quality focus, and good communication, and you can see the potential of being a true expert in this certain area of expertise. On a personal level, you have a quality mindset, you are a team player with the ability to work independently. You possess good communication and collaboration skills combined with a structured way of working, and with a good sense of humour. At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development. Contact For further information, please contact Lise Linde at +453075 8346. Deadline 18 October 2015.

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

Arbejdsgiver faxnummer: 44442314

Job kort beskrivelse: Farmaceutarbejde

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark

GÆLDER

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