Data Management Process Specialist
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Søborg
Do you wish to be part of a highly professional and engaging global environment bringing new medicines to market? Do you want to apply your expertise in developing a state-of-the-art Quality Management System with an innovation mindset and to contribute to an efficient and aligned way of working across the Data Management value chain? Then our department offers an exciting opportunity as Principal Data Management Specialist. Apply now and join us on the journey to drive change for a healthy world today, and for generations to come! About the Department
In Novo Nordisk Development, we manage clinical drug development globally, while adhering to international standards, regulations, and ethics. Our Data Management Process & Innovation department is part of Data Management under Data Science and comprises 15 knowledgeable and passionate individuals who specialize in data management processes & guidelines, regulatory compliance, competency development, change management, innovation, automation, visualization, and digitalization. Currently, five specialists focus on processes, instructions, guidelines, change management, and integration projects. We collaborate with various departments and skill areas to provide advice and improve the Data Management community, which includes approximately 375 professionals in the US, Spain, India, and Denmark. The position
The position will have a primary focus on the continuous augmentation of the quality management system which includes developing of Standard Operating Procedure’s (SOP), guidelines, and position papers based on new regulatory requirements. Impact the landscape of deliverables across the value chain and this position will be a key driver of many initiatives across both the Data Management and Data Science organisations. In addition, you will: Be part of handling our setup for dealing with authority inspections Act as project lead on ongoing improvement initiatives and be an advisor on key data management systems and related issues Be involved in integrations between the current Data Management function and acquired organizations Be empowered to proactively identify development areas and build innovative solutions to meet the current and future needs of Novo Nordisk in an evolving regulatory landscape Coordinate, plan, communicate, and lead across the company and ensure learnings will be captured and shared on an ongoing basis We expect you to be a bridge-builder to key stakeholders across the Development area, and work smoothly across organisational levels, from senior management teams to end-users of the initiative you are driving as part of a continuous transformation of Data Management and related Systems & Standards. Strategically we wish to focus efforts on developing our organization to handle the needs of the future with respect to our way of working and systems. Qualifications
To thrive and succeed in this role, you have: University degree (MSc/Ph.D.) within Natural sciences, Engineering, Computer Science, IT or other relevant fields Background in development of a quality management system and GxP documents Strong insight in the regulatory requirements for conducting clinical development Experience that demonstrates abstract reasoning skills, and the ability to evaluate diverse technological capabilities and apply them to improving data management processes along with demonstrated project management skills within the scope of the position. Proven track record with risk-based methodologies to drive fit-for-purpose solutions It will be a strong advantage if you have hands-on experience from large-scale Quality Management System (QMS) projects connecting across skill areas. In addition, exposure on integrating QMS across organizations and handling both the strategic and operational aspects of such integrations. On a personal level, you are a team-oriented driver, who enjoys working both laterally and horizontally and across multiple disciplines. You are eager to see things moving forward and possess the drive to make things happen which has a positive and motivating effect on your stakeholders and team members. Strong communication skills with proficient written and spoken English. Working at Novo Nordisk
Novo Nordisk is its people. We know that life is anything but linear and balancing what is important at different stages of our careers is never easy. That’s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees. Together, we go further. Together, we’re life changing. Contact
For further information, please contact Henrik Steen Andersen (Director, DM Process & Innovation) at +45 30 77 57 09 Deadline
11 April 2023. Please note, applications will be review and interviews will be conducted on an ongoing basis. You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
In Novo Nordisk Development, we manage clinical drug development globally, while adhering to international standards, regulations, and ethics. Our Data Management Process & Innovation department is part of Data Management under Data Science and comprises 15 knowledgeable and passionate individuals who specialize in data management processes & guidelines, regulatory compliance, competency development, change management, innovation, automation, visualization, and digitalization. Currently, five specialists focus on processes, instructions, guidelines, change management, and integration projects. We collaborate with various departments and skill areas to provide advice and improve the Data Management community, which includes approximately 375 professionals in the US, Spain, India, and Denmark. The position
The position will have a primary focus on the continuous augmentation of the quality management system which includes developing of Standard Operating Procedure’s (SOP), guidelines, and position papers based on new regulatory requirements. Impact the landscape of deliverables across the value chain and this position will be a key driver of many initiatives across both the Data Management and Data Science organisations. In addition, you will:
To thrive and succeed in this role, you have:
Novo Nordisk is its people. We know that life is anything but linear and balancing what is important at different stages of our careers is never easy. That’s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees. Together, we go further. Together, we’re life changing. Contact
For further information, please contact Henrik Steen Andersen (Director, DM Process & Innovation) at +45 30 77 57 09 Deadline
11 April 2023. Please note, applications will be review and interviews will be conducted on an ongoing basis. You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
Information og data
Denne ledige stilling har jobtypen "Forretningsudvikler", og befinder sig i kategorien "Kommunikation, marketing, salg".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 24.3.2023, 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.
- Forretningsudvikler
- Søborg
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