stillingsbetegnelse: RegOps Project Manager

jobbeskrivelse:
- Regulatory Affairs - Denmark - Søborg Our growth is your opportunity Being part of Novo Nordisk Research & Development means working at one of the world's largest and most successful biopharmaceutical companies. Our R&D organisation is vital to Novo Nordisk's continued growth and we always welcome talented people who would like to grow with us. Our growth is your opportunity. Being part of Novo Nordisk Research & Development means working at one of the world's largest and most successful biopharmaceutical companies. Our R&D organisation is vital to Novo Nordisk's continued growth and we always welcome talented people who would like to grow with us About the department To support the growing number of global electronic submissions in Novo Nordisk, we need a new project manager in the Regulatory Affairs (RA) Publishing Management department. As a Project Manager within publishing, you will be interacting throughout the company in relation to planning, compiling, publishing and delivery of eCTD’s, and other submission format types. The RA Publishing Management department is situated in Søborg where our group of ten people in close cooperation with our sister departments in the US and in India support the organisation with submission compilation, publishing and archiving services. The job The Project Manager’s main task will be to manage major global eSubmission projects in cooperation with the regulatory teams, the report publishing units, and the global regulatory publishing team. Another key task will be to globalise our publishing processes by supporting key affiliates in finalising their local submissions. You have a firm grasp and understanding of the evolving eSubmission standards, and will ensure that we always deliver efficient, timely and compliant submissions to the Regulatory Agencies. On top of managing eSubmission projects, you will be an active player in the constant strive of optimising the compiling and publishing process; e.g. by improving the use of Word style templates, document management systems, publishing systems, validation tools, and agency portals. You will work in a fast paced environment where no two days are alike. Tight deadlines, cross-departmental collaboration, and the challenges of international communication will be part of your busy workday. You will be expected to make an impact, to ask questions, and to challenge the status quo - if that’s what it takes. Qualifications You have a master’s degree within life sciences or IT and have a strong proven track record as a project manager within Regulatory Operations or Regulatory Affairs. You ideally already have extensive knowledge of document management and eCTD publishing systems You are strong in setting direction and making impact but also have the ability to “hands on” manage all the classical disciplines within publishing. You are a team player that maintains customer focus even when delivering submissions under sometimes tough circumstances. As a person you are well organised, have solid problem solving capabilities, just as you show a winning and positive attitude, and never lose your strategic focus. You can keep your spirits high even when under pressure, and 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. 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 Poul Erik Hansen at +45 3075 9625. Deadline 24 November 2014.

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 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