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reference: 4973472

documentId: 4973472

connectionPointId: 7

lastModificationDate: 1554899431466

stillingsbetegnelse:
Competency Development Specialist to lead new initiatives within trial management

jobbeskrivelse:

Do you display leadership talent and flair for innovative solutions, and do you thrive on working with people across an organisation? Then you might be our new Competency Development Specialist. In this job you will be the owner of the processes surrounding Trial Master File (TMF) archival requirements; spanning across all systems containing trial master file records. This process is new and building the frame and processes will be the responsibility of this role. 

You will collaborate globally with a wide range of Novo Nordisk colleagues across the organisation. The span of the position is in our clinical development area, across R&D and in other areas such as Novo Nordisk affiliates globally, Clinical Supplies, Regulatory Affairs, and Global Safety. You can look forward to a diverse job with high impact and visibility. 

In Global Development, we are responsible for managing clinical drug development worldwide from early development phases to product introduction and life cycle management. 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 Trial Management Anchor is part of Global Development. We are a team of 13 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 International Study Groups in the drug development projects.

 

The position

Collaborating closely with the 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 the retention of TMF. You will need to be updated on various external requirements and changes to these, making sure Novo Nordisk is in compliance at all times, while striving for simplicity in our working procedures.

 

Qualifications

You hold an academic degree as a Librarian or in life science, bioscience or other equivalent education combined with at least 5 years of experience within the area of document management in the pharmaceutical industry. You have comprehensive IT skills and understanding, and experienced within quality assurance and GXP. You have a thorough understanding of the entire drug development life cycle, and you have a drive for influencing and taking leadership through your specialist knowledge and networking ability. 

Due to the extent of different stakeholders we expect you to work independently and have excellent communication and presentation skills. Interactions with internal and external experts require proficiency in English. You are analytical, well organised and understand what it takes to navigate in matric organisation with related governance. Since you will have the responsibility for a new process we expect you to have a proactive and outgoing mind-set.

 

Working at Novo Nordisk

At Novo Nordisk, we use our skills, dedication and ambition to help people with diabetes and related chronic metabolic diseases. We offer the chance to be part of a truly global workplace, where passion and commitment are met with opportunities for professional and personal development.

 

Contact

For further information, please contact Jeannett Dimsits +45 30796604

 

Deadline

All enquiries will be handled confidentially. Please submit your cover letter (application), CV and other relevant papers online no later than 23 April 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.

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C2423

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