Clinical Disclosure Specialist
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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 Disclosure team at Novo Nordisk to get a life-changing career and make a difference to millions of people with chronic diseases.
About the department
The Clinical Disclosure team in Novo Nordisk is responsible for ensuring compliance with global clinical disclosure and transparency requirements. The team coordinates and manages global clinical disclosure activities and maintains IT systems to support evolving requirements from health authorities worldwide.
Clinical Disclosure is part of the Medical Writing function at Novo Nordisk and is anchored in Clinical Reporting, Global Development. The department consists of 8 disclosure professionals working together in a pleasant, busy and informal environment.
The Position
The position is a 1 year temporary position as Disclosure Specialist. In this position, one of your main tasks will be to drive successful implementation of a new IT tool for automated risk assessment, redaction and anonymisation of clinical documents for public disclosure in accordance with Novo Nordisk and external requirements. You will represent line of business (Clinical Disclosure) and work in close collaboration with an IT project manager, the external vendor as well as future users in the global Clinical Disclosure team in HQ and India.
In addition, you will be responsible for continuous development of the PharmaCM IT system for managing the complex process of authoring, reviewing, editing, approving and publishing clinical trial application and disclosure data and for trouble shooting of issues. This includes contact to both vendor and the IT organization to ensure Novo Nordisk interests are covered in updates relating to new requirements.
In general, you will leverage your knowledge of clinical trial methodology and regulatory requirements in relation to clinical disclosure to contribute to trial and results registrations to EMA and FDA, as well as additional disclosure activities in relation to e.g. EMA and Health Canada.
The position is located in Søborg, Denmark. Some travel is expected.
Qualifications
You hold an MSc or a PhD (e.g. in IT or natural/life science) and have knowledge of GCP and other relevant regulatory requirements affecting the conduct of clinical trials, e.g. through experience from Regulatory Affairs, and preferable also knowledge about the requirements in relation to clinical trials registration and transparency.
You have experience with IT project management and implementation of IT tools. You are quick at learning to use new software and interested in understanding the more technical details, and at the same time you have a keen interest in understanding the end-user needs.
You have excellent written and spoken English skills and have an analytical mind-set. You are proactive and able to prioritise your tasks efficiently to make room for ad hoc requests when needed.
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 Tine Møller, +45 3075 7052.
Deadline
18 January 2020
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 "Jurist", og befinder sig i kategorien "Økonomi og jura".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 8.1.2020, 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.
- Jurist
- Søborg
- Lørdag den 18. januar 2020
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