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reference: 4916349

documentId: 4916349

connectionPointId: 7

lastModificationDate: 1544442667940

stillingsbetegnelse:
Senior Regulatory Professional for Regulatory Affairs, CTA Management

jobbeskrivelse:

Join a fast-changing environment where engaged people do their best every day to ensure optimal processes for clinical trial applications worldwide for Novo Nordisk across the globe. Do you have the combination of scientific insight, strong process management skills and the ability to navigate many agendas and stakeholders simultaneously? Then you might be the Senior Regulatory Professional we are looking for in Regulatory Affairs Clinical Trial Application (RA CTA) Management.

 

About the department

RA CTA Management is a centralized department in Regulatory Operations, Regulatory Affairs in Søborg, Denmark. We are a team of 9 highly motivated and engaged employees being responsible for coordinating the document packages for clinical trial applications (CTA) submitted to Health Authorities and Ethics Committees worldwide.

 

You will work with experienced colleagues and many different stakeholders within Novo Nordisk headquarters and affiliates in 60 countries. In this dynamic environment, we are continuously improving and aligning our CTA processes to adapt and ensure compliance with the increasingly complex regulatory environment. We offer interesting and challenging assignments and good opportunities for personal and professional development.

 

The Job

You will have a central role in ensuring efficient processes around the coordination and maintenance of CTAs for submissions and approvals worldwide, and thereby supporting the Novo Nordisk project and product portfolio. In this role, you will provide process support and regulatory expertise to your colleagues in RA CTA Management as well as to our stakeholders across the organisation in HQ and affiliates.  

 

You will be representing RA CTA Management in various cross-functional groups and projects across the organisation, and you will be involved in the many improvement activities to develop, optimise, and standardise the Novo Nordisk CTA process. Driving projects and ensuring efficient communication and change management across the organisation is an integrated part of the job.

 

Qualifications

You have a Master of Science within pharmacy, natural sciences or other relevant degrees and some years of regulatory or clinical trial management experience either from the pharmaceutical industry or from a medical agency working with CTAs or the trial initiation phase. In addition, it is important to have a strong interest and good understanding of regulatory guidelines and regulatory affairs.

 

We expect that you can drive projects and activities independently and systematically and that you enjoy working in a dynamic environment. You can stay on target, work with tight deadlines and manage multiple assignments at the same time without losing track. You have strong analytical skills and proactive problem-solving abilities using a pragmatic approach. You address responsibilities with decisiveness, a positive and open mindset, and finally a healthy sense of humor. 

You have good negotiation skills, advanced communication skills as well as experience with presenting in large fora as stakeholder management and communication are essential for succeeding in the job. Finally, full professional proficiency in oral and written English is a must.

 

Contact

For further information, please contact Tara Elvang at +45 3075 2456.

 

Deadline

30 December 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/C2423

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