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reference: 4902058

documentId: 4902058

connectionPointId: 7

lastModificationDate: 1541589975310

stillingsbetegnelse:
Senior Project Manager in Submission Management, Regulatory Operations

jobbeskrivelse:

Do you have extensive experience from Regulatory Operations or Regulatory as Project Manager and do you want to exert your influence by leading global submission publishing projects and participate in major submission related IT projects? Then we may have just the right job for you.

 

Regulatory Operations - Submission Management is looking for a Senior Project Manager to join us.

 

About the department

To support both the growing number of global electronic submissions in Novo Nordisk and to ensure a robust and visionary design of our processes when working with submission documents and submission related activities in our future IT set-up, we need a new Project Manager in the Submission Management area.

 

As a Senior Project Manager in Submission Management, you will be interacting with many stakeholders in the company in relation to planning, compiling, publishing and delivery of eCTDs, and other submission format types. Furthermore, you will participate in our major IT projects, where you will be involved in establishing user requirements and future work processes; vendor evaluation and selection; informal and formal testing of a future system as well as ensuring implementation activities.

 

The Submission Management area is situated in Søborg with four departments in Denmark and three sister departments in Bangalore, India. We work with coordination of Clinical Trial Application, Registration Information Management (RIM) handling, submission document compilation and publishing to health authorities worldwide.

 

The position

The Senior Project Manager’s main task will be to take part in the design and implementation of our next generation document and submission processes and IT set-up. Furthermore, a main responsibility is to manage major global eSubmission projects in cooperation with the regulatory teams, the report publishing units, and the global regulatory publishing team. Finally, another key task will be to improve our publishing processes when supporting our colleagues in India and 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.

 

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 to ensure continuous improvements and future proof, visionary systems and services.

 

Qualifications

You have a master’s degree preferably within life sciences and have a strong proven track record as a project manager within Regulatory Operations or Regulatory Affairs. You already have extensive knowledge of document management and eCTD publishing processes, insight into the classical regulatory disciplines and experience from participation in major IT transformation projects.

 

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 who maintains customer focus even when delivering submissions under sometimes tough circumstances.

 

As a person you are well organised, analytical with 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 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.

 

In Novo Nordisk A/S it is your skills, your commitment and your ambitions which help us to improve many people’s lives. In return we offer you the opportunity to work with talented colleagues, and we offer you a wide range of opportunities for professional and personal development.

 

Contact

For further information, please contact Vice President Pil Elisabeth Mortensen at +45 3079 0635.

 

Deadline

28 November 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/C1219

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