Arbejde Team Leader Publishing Support, Regulatory Operations Hovedstaden Danmarks Tekniske Universitet - jobtilbud
Team Leader Publishing Support, Regulatory Operations
jobbeskrivelse:
- Management - Denmark - Søborg 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. Are you ready to lead and motivate a team of highly skilled Regulatory Publishers in a department working with supporting the growing number of electronic lifecycle submissions to health authorities? Then we have an exciting job for you in Publishing Support part of Global Submission Management, Regulatory Operations in Søborg. About the department Global Submission Management is a department in Regulatory Operations (part of Regulatory Affairs). Regulatory Affairs is a fast-changing field, and the 450 employees serve as Novo Nordisk’s advocates around the world – and make a meaningful difference to our business making medicine available to patients all over the world by ensuring rapid regulatory approval in all markets. In the Publishing Support team we are responsible for planning, compiling, publishing, production and delivery of lifecycle eCTDs, and other submission format types. The team interacts with many stakeholders in the company and on top of publishing lifecycle submissions, they are active players in the constant strive for optimisation of the use of our IT systems and continuous improvements of the compiling and publishing processes. You will be reporting to the Director of the Global Submission Management department and you will be responsible for six Regulatory Publishers including the responsibility for the Regulatory Affairs archives situated in Søborg, Denmark. The team works closely with Regulatory Publishers in our department in India and the publishing team in the US as well as with affiliates primarily in the EU; and the job as Team Leader requires frequent communication and alignment with these partners with the possibility for international travel. The Job You will be responsible for a team actively involved in the regulatory publishing process, and with your team, you will interact and cooperate closely with important stakeholders in the Regulatory Affairs therapeutic areas, the Novo Nordisk affiliates and the publishing support team in India to ensure timely submission of regulatory files. You lead by example and you set direction. As part of the management team in the Global Submission Management department, you will be responsible for implementing common goals and strategies in your area. You are responsible for your team’s performance through the setting of goals and their tracking. In addition, you know how to motivate and develop your employees. Qualifications You hold a master’s degree in e.g. science/pharmacy/medicine or business/marketing. You have a minimum of 2 years of management experience and your quality mind-set is well-developed. You possess good coordination and planning skills; you are accountable and have the ability to work under tight deadlines. It is important to be service minded and to adapt to changes easily in a dynamic environment. You have experience with professional use of IT systems and are proficient in the MS Office. Ideally, you have good knowledge of document management and eCTD publishing processes as well as insight into the classical regulatory disciplines. You have an understanding of the evolving eSubmission standards, and you will work to ensure that we always deliver compliant submissions efficiently and timely to the Regulatory Agencies in the European countries. Personally, you are driven and have the ability to work independently with decisiveness and good analytical skills. You have a sense of initiative combined with empathy and the ability to support and engage your employees. You have a positive mind-set and you enjoy working in a dynamic environment. You are a skilled communicator, who is able to collaborate wi
Arbejdsgiver Navn: Danmarks Tekniske Universitet
Arbejdsgiver telefonnummer: 45252525
Arbejdsgiver faxnummer: 45881799
Job kort beskrivelse: Farmaceutarbejde
land: Danmark
region: Hovedstaden
Kontrakt varighed: Fast
Kontrakttype: Fuldtid
krævede uddannelse: Ikke angivet
Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark
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