Clinical Publisher with IT experience
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Søborg
- Clinical Development and Medical
- Søborg
Do you look forward to taking your career to the next level?
Join the Clinical Publishers at Novo Nordisk to get a life-changing career and make a difference to millions of people with chronical diseases.
About the department
Clinical Publishers is a department responsible for the Trial Master File (TMF) archive and for compiling the clinical documentation such as Clinical Trial Reports for the submission of a new drug application to regulatory authorities. We support and train the clinical organisation in the use of novoDOCS (Novo Nordisk's electronic document management system), and in our clinical document templates and IT tools.
Clinical Publishers is part of the Medical Writing function at Novo Nordisk and is anchored in Clinical Reporting, Global Development. The department consists of 3 TMF archive assistants and 7 clinical publishers and comprises many different nationalities working together in a pleasant, busy and informal environment.
The position
One of your main tasks will be to support the process for compilation and publishing of Clinical Trial Reports (CTRs), Investigator's Brochures (IBs) and submission documents. As clinical publisher you check and compile relevant clinical documentation from many different stakeholders throughout the organisation. You will ensure that we have all the relevant clinical documents needed for regulatory submissions, and that they are delivered in the right electronic quality (file size, bookmarks, links, margins etc.) to Regulatory Affairs.
You will be using various IT systems, such as novoDOCS, InSight Publisher, Adobe Acrobat Professional and Microsoft Office, to check and compile the documents. You will also provide support to the organisation in the use of novoDOCS and word templates. Moreover, you will act as a system manager for Clinical Reporting IT systems and support and train in Teams, Sharepoint online and Office 365 (including Flow, Forms, PowerApps, etc).
Subsequently, you will be accountable for development and tool upgrades of small relevant IT systems.
Based on your experience, you will also be responsible for the planning, managing and driving of small projects.
This position is in Søborg, Denmark. Some travel is expected.
Qualifications
You hold a master or a bachelor's degree (i.e. librarian, IT, natural/life science) and have a flair for learning new software.
You have substantial experience with PDF handling tools and MS Office.
You are a fast learner, possess excellent communication skills and you are experienced in providing training and support in the use of various IT programs. It is an advantage if you have programming language experience.
As a person, you have excellent written and spoken English skills and have an analytical mind-set. You are both proactive, service minded, team oriented and thrive working under tight deadlines.
Working at Novo Nordisk
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 Klaus Laigaard at +45 3079 3894.
Deadline
Interviews will be held on an ongoing basis so please submit your CV, application, and educational documentation as soon as possible but no later than 14-Nov-2019.
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.
Information og data
Denne ledige stilling har jobtypen "Kommunikationsmedarbejder", og befinder sig i kategorien "Kommunikation, marketing, salg".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 28.10.2019, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Kommunikationsmedarbejder
- Søborg
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