Senior Trial Master File (TMF) Professional
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Søborg
- Clinical Development and Medical
- Søborg
Are you IT savvy and can display flair for innovative solutions, and do you thrive on working with people across an organisation? Are you curious about the new ways of working with the trial master file (TMF) and documentation? Then you might be our new Senior Trial Master File (TMF) Professional in this temporary 12-month position, fulfilling the Trial Master File (TMF) Archivist role. In this job, you will be the driver of the processes surrounding TMF archival requirements, working across all systems containing trial master file records. This process, which is a Health Authority requirement, is new, and building the frame and defining the tasks will be the responsibilities of this role. You will be part of a dedicated team working with the TMF process and system. You will collaborate globally with a wide range of Novo Nordisk colleagues across the organisation spanning from Global Development, across R&D and other functional areas such as Novo Nordisk affiliates, Clinical Supplies, Regulatory Affairs, and Global Safety. You can look forward to a diverse job with high impact and a possibility to pave new ways.
In Global Development, we are responsible for managing clinical drug development worldwide from early development phases to product introduction. We ensure delivery of documentation for clinical submissions to authorities while ensuring that the process lives up to uniform global standards, regulations and business ethics.
About the department
The position is based in the Trial Management Anchor within the Trial Operations Centre of Expertise. We are a team of 14 dedicated colleagues with a shared interest in optimisation and competency building within trial management. We develop and maintain the framework and processes related to the work of trial management globally and Trial Squads in the drug development projects.
The position
Collaborating closely with colleagues in the TMF group and the Senior Director of the Trial Management Anchor and stakeholders in headquarters and affiliates, you will drive, support, facilitate and maintain the process around archiving, retention and destruction. The position resides in an IT heavy area where you will control and maintain IT processes. You will need to stay up-to-date on various external requirements and changes to these, ensuring that Novo Nordisk is in compliance at all times, while striving for simplicity in our working procedures.
Temporary position, 01-March-2020 until 28-February-2021
Qualification
You hold an academic or Master’s degree in library sciences, life sciences or other equivalent education, or possess relevant IT experience, combined with at least 3-5 years of experience within the area of process, database, and document management in the pharmaceutical industry. You have comprehensive and up-to-date IT skills and are experienced in quality assurance and GxP.You have a thorough understanding of drug development, and you have a drive for influencing and taking leadership through your specialist knowledge and networking ability.
You can work and fulfill tasks independently, but are also a team player. You are proactive and can drive projects when necessary. You possess excellent communication and presentation skills and are willing to reach out to, interact and collaborate with both internal and external experts. You are analytical, structured, and possess the ability to prepare for challenges ahead and detect blind spots that will need to be remedied accordingly. You are change-prepared and have a high degree of integrity.
Contact
For further information, please contact Birgitte Claudius at +45 3079 9668.
Deadline
5 February 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 "Afdelingsleder", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 7.1.2020, 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.
- Afdelingsleder
- Søborg
- Onsdag den 05. februar 2020
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