stillingsbetegnelse: Senior Regulatory Project Manager – Haemophilia

jobbeskrivelse:
- Project Management - Denmark - Søborg Are you on the lookout for the opportunity to combine your scientific understanding, regulatory insight and project management skills? About the department At Novo Nordisk Regulatory Affairs (RA), we strive to make new and better medicines available worldwide, for among others people with diabetes and haemophilia. In the haemophilia area we currently have 3 approved drugs (NovoSeven®, NovoThirteen® and NovoEight®) and 2 new haemophilia drugs in late stage phase 3 development. We also have an interesting pipeline of early stage products. The job We are looking for a Senior Regulatory Project Manager with an interest in the Haemophilia area to lead our team of specialists working with NovoEight®. NovoEight® has recently been approved in the US, EU, Japan and Switzerland. You will be responsible for life-cycle management of these market authorisation coordinating the submission and approval of CMC and clinical variations. You will also plan and coordinate new marketing authorisation submissions in other regions worldwide. The NovoEight® team consists of 3-4 regulatory professionals and 2 associates. You’ll be responsible for all aspect of the regulatory affairs discipline for NovoEight®, interactions with health authorities, and leading the team. You will work closely with our medical, marketing, product supply and quality assurance departments, as well as with Novo Nordisk affiliates and regulatory authorities around the world. Furthermore you will need to understand the diverse needs of the people you work with, so you can facilitate effective collaboration among a wide range of parties, even in the face of difficult challenges. You will report to the Director, RA Haemophilia New Projects and be a member of the Global Project Team for NovoEight®, the Global Regulatory Team for Haemophilia projects, as well as the management team in the Haemophilia area. You will also be involved in cross functional projects and improvement initiatives within and outside the RA organisation. Qualifications We expect you to have a university degree in science and proven record of global regulatory understanding and experience of successful liaison with regulatory authorities, good therapeutic understanding, as well as cross-organisational experience in all phases of global drug development with a particular focus on late-stage/marketed products. You have documented project management experience from the pharmaceutical industry. You set clear direction, and enjoy leading and motivating your project members to work for joint objectives. As a person you are positive, well organised and have solid problem solving capabilities, just as you show a winning attitude and never lose your strategic focus. You can keep your spirits high even when under pressure, and can support and organise your team to achieve the project goals. As a skilled communicator you can cooperate at any organisational level. Finally, you are comfortable using your fluent written and spoken English on a daily basis. Regulatory Affairs is an organisation with many international employees and we welcome non-local applicants. We have great experience helping people move to Denmark and will support relocation. English is the working language and over 80% of Danes speak English. The position is based 10 km outside of Copenhagen. Denmark has an excellent work-life balance and high quality public health, education and childcare systems. Depending on qualifications and work experience, some foreign candidates can qualify for lower tax. At Novo Nordisk we use our skills, dedication and ambition to help people with diabetes and haemophilia change their lives. By working with us you will have the opportunity to join us in this challenge. Contact For further information, please contact Alice Troy at +45 3075 4026 or Henrik K. Nielsen at +45 3079 6298. Deadline 31 August 2014

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: +45 44448888

Job kort beskrivelse: Farmaceutarbejde

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark