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International Medical Director-International Medical Manager (Søborg, Denmark)

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International Medical Director/International Medical Manager

- Research & Development, Medical Doctor
- Denmark - Søborg

The Medical & Science, Degludec II department at Novo Nordisk A/S is seeking a physician to take on a position as International Medical Director/Manager working with diabetes projects in Novo Nordisk. We are looking for a medical doctor with documented clinical and scientific knowledge about diabetes. A candidate with experience from clinical development work within the pharmaceutical industry and knowledge about interaction with regulatory agencies will be preferred. The job will require strong interaction with highly engaged colleague’s world-wide and external stakeholders including treating physicians and therapeutic experts.

About the department
The department is medically responsible for planning and conducting clinical studies as well as medical input to regulatory documents and health authority interactions. The candidate will be involved in these activities closely interacting and collaborating with the NN organization globally.

The Job
Key responsibilities of the successful candidate will be to take up the role as Medical Specialist within the assigned projects. This includes being instrumental in creating regulatory documents, implement clinical development strategies for a drug candidate, updating Clinical Development Plans, executing clinical studies phases 1-3 and providing medical deliverables to the paediatric investigational plans for a drug candidate.

A specific focus will be to provide input to the content and quality of the regulatory documents, Clinical Part of the Submission Dossier as well as creating / writing relevant risk-assessment plans, medical content of trial outlines, protocols, clinical trial reports, paediatric investigation plans, IMPDs and publications and presentation of medical aspects of the clinical development program at internal and external meetings (including meetings with health authorities, congresses, investigator meetings etc.).

Qualifications
You have a medical degree including scientific training (PhD, DMSc or equivalent), and preferable knowledge within diabetes or metabolic conditions. It will be an advantage if you have previous experience from the pharmaceutical industry and experience from interaction with regulatory authorities e.g. NDA submissions, scientific advice or similar. You are a reliable, open-minded and dedicated team player, who thrives in a global environment of continuous development, and focuses on completion, quality and results. Interaction with internal and external experts require proficiency in English, high communication, coordination and planning capacities, as well as flexibility and a keen sense of quality. You may expect certain travelling activity of approximately 10%.

At Novo Nordisk, we create value by putting patients first. Every ten seconds two people are diagnosed with diabetes, and close to 366 million people worldwide need us. Working here is not just a way to make a living, but a way to make a difference.”

Contact
For further information, please call Pernille Poulsen on +45 3075 9214.

Deadline
12 August 2013.

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