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Quality Supporter

Do you like working with a variety of stakeholders? Do you have a keen eye for quality? Do you get energised by solving problems and ensuring optimisation? Do you have experience with Deviations and Change Requests? Then you might be the Quality Supporter we are looking for in our Quality Support team.

  

About the department

Sourcing Operations (SoOp) is the inbound supply chain unit in Product Supply, and is responsible for purchasing, quality control, distribution and warehousing of the thousands of materials going into the production worldwide. The job is in the Quality Support Team, a team in Inbound Supply Management, a part of SoOp. Inbound Supply Management is responsible for supporting the supply chain across SoOp in becoming more robust, effective and efficient, and to ensure reliable supply of quality products (raw and packaging materials). 

The Quality Support team is based in Bagsværd and is responsible for driving Deviations, Change Requests and for ensuring continuous improvement of processes and systems that support the quality of products sourced by SoOp.

 

The position

In Sourcing Operations, our ambition is to deliver high quality products and services to our global production sites. As a Quality Supporter, you will be responsible for driving Deviations and Change Requests on raw and packaging materials. The Deviations and Change Requests are handled in close collaboration with colleagues in Novo Nordisk and external suppliers. You will interact with a various number of stakeholders e.g. Packaging lines, Quality Assurance (QA), process experts and Supply Managers. You will need to balance different needs and requests, while both ensuring a high quality and timely execution of your tasks. You will also participate in tasks or projects aiming at improving compliance and continuous improvement of our work processes. 

You can look forward to joining a dynamic organisation where you will get a wide range of contacts internally in Novo Nordisk and with suppliers.

 

Qualifications

Ideally, you have an academic degree within a relevant discipline such as Engineering, MSc, or the like combined with 2-3 years of relevant experience working with inbound supply processes, handling quality documentation, deviations, change requests and you are skilled at systematic problem solving. Additionally, you understand the GMP requirement standards of the pharmaceutical industry. Knowledge of Purchasing and Supply Chain Management is an advantage. 

On a personal level, you are structured, pro-active and it is natural for you to work in a dynamic environment with many simultaneous tasks and changing priorities while managing strict deadlines. You are independent and not afraid to take initiatives, and you contribute positively and actively to the team environment. You are persistent in achieving results at the right quality level and you thrive in solving complex tasks and communicating in a constructive way based on your knowledge and understanding of quality.

 

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 Pia Bech Vince at +45 3079 2171.

 

Deadline

15 June 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.


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330027853Phoenix-056f6eba12019-06-04T00:00:00Quality Supporter

Do you like working with a variety of stakeholders? Do you have a keen eye for quality? Do you get energised by solving problems and ensuring optimisation? Do you have experience with Deviations and Change Requests? Then you might be the Quality Supporter we are looking for in our Quality Support team.

  

About the department

Sourcing Operations (SoOp) is the inbound supply chain unit in Product Supply, and is responsible for purchasing, quality control, distribution and warehousing of the thousands of materials going into the production worldwide. The job is in the Quality Support Team, a team in Inbound Supply Management, a part of SoOp. Inbound Supply Management is responsible for supporting the supply chain across SoOp in becoming more robust, effective and efficient, and to ensure reliable supply of quality products (raw and packaging materials). 

The Quality Support team is based in Bagsværd and is responsible for driving Deviations, Change Requests and for ensuring continuous improvement of processes and systems that support the quality of products sourced by SoOp.

 

The position

In Sourcing Operations, our ambition is to deliver high quality products and services to our global production sites. As a Quality Supporter, you will be responsible for driving Deviations and Change Requests on raw and packaging materials. The Deviations and Change Requests are handled in close collaboration with colleagues in Novo Nordisk and external suppliers. You will interact with a various number of stakeholders e.g. Packaging lines, Quality Assurance (QA), process experts and Supply Managers. You will need to balance different needs and requests, while both ensuring a high quality and timely execution of your tasks. You will also participate in tasks or projects aiming at improving compliance and continuous improvement of our work processes. 

You can look forward to joining a dynamic organisation where you will get a wide range of contacts internally in Novo Nordisk and with suppliers.

 

Qualifications

Ideally, you have an academic degree within a relevant discipline such as Engineering, MSc, or the like combined with 2-3 years of relevant experience working with inbound supply processes, handling quality documentation, deviations, change requests and you are skilled at systematic problem solving. Additionally, you understand the GMP requirement standards of the pharmaceutical industry. Knowledge of Purchasing and Supply Chain Management is an advantage. 

On a personal level, you are structured, pro-active and it is natural for you to work in a dynamic environment with many simultaneous tasks and changing priorities while managing strict deadlines. You are independent and not afraid to take initiatives, and you contribute positively and actively to the team environment. You are persistent in achieving results at the right quality level and you thrive in solving complex tasks and communicating in a constructive way based on your knowledge and understanding of quality.

 

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 Pia Bech Vince at +45 3079 2171.

 

Deadline

15 June 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.

2019-06-16T00:51:13.160 Do you like working with a variety of stakeholders? Do you have a keen eye for quality? Do you get energised by solving problems and ensuring optimisation? Do you have experience with Deviations and Change Requests? Then you might be the Quality Supporter we are looking for in our Quality Support team. About the department Sourcing Operations (SoOp) is the inbound supply chain unit in Product Supply, and is responsible for purchasing, quality control, distribution and warehousing of the thousands of materials going into the production worldwide. The job is in the Quality Support Team, a team in Inbound Supply Management, a part of SoOp. Inbound Supply Management is responsible for supporting the supply chain across SoOp in becoming more robust, effective and efficient, and to ensure reliable supply of quality products (raw and packaging materials). The Quality Support team is based in Bagsværd and is responsible for driving Deviations, Change Requests and for ensuring continuous improvement of processes and systems that support the quality of products sourced by SoOp. The position In Sourcing Operations, our ambition is to deliver high quality products and services to our global production sites. As a Quality Supporter, you will be responsible for driving Deviations and Change Requests on raw and packaging materials. The Deviations and Change Requests are handled in close collaboration with colleagues in Novo Nordisk and external suppliers. You will interact with a various number of stakeholders e.g. Packaging lines, Quality Assurance (QA), process experts and Supply Managers. You will need to balance different needs and requests, while both ensuring a high quality and timely execution of your tasks. You will also participate in tasks or projects aiming at improving compliance and continuous improvement of our work processes. You can look forward to joining a dynamic organisation where you will get a wide range of contacts internally in Novo Nordisk and with suppliers. Qualifications Ideally, you have an academic degree within a relevant discipline such as Engineering, MSc, or the like combined with 2-3 years of relevant experience working with inbound supply processes, handling quality documentation, deviations, change requests and you are skilled at systematic problem solving. Additionally, you understand the GMP requirement standards of the pharmaceutical industry. Knowledge of Purchasing and Supply Chain Management is an advantage. On a personal level, you are structured, pro-active and it is natural for you to work in a dynamic environment with many simultaneous tasks and changing priorities while managing strict deadlines. You are independent and not afraid to take initiatives, and you contribute positively and actively to the team environment. You are persistent in achieving results at the right quality level and you thrive in solving complex tasks and communicating in a constructive way based on your knowledge and understanding of quality. 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 Pia Bech Vince at 45 3079 2171. Deadline 15 June 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.11jobnet056f6eba100000000000IDK_OFIR_02DKDanmark228DKK2019-06-15T00:00:000000https://www.novonordisk.com/careers/working-at-novo-nordisk/job-ad-display.11474.en_GB.html0EuropaDanmarkSjælland & øerStorkøbenhavnHerlevEuropaDanmarkSjælland & øerStorkøbenhavnFuresøEuropaDanmarkSjælland & øerStorkøbenhavnGladsaxe3530803NOVO NORDISK A/S11Novo Alle 12880BagsværdDKDanmark0DKDanmarkDKDanmark8Fuldtid46Permanent764246JobNet4992232499223210021-05-20190https://dispatcher.ofir.dk/statistic/register?context=FeedEntrySearchedCount&feedId=dc2beb84&entryId=056f6ebahttps://dispatcher.ofir.dk/statistic/register?context=FeedEntryDisplayCount&feedId=dc2beb84&entryId=056f6ebahttps://dispatcher.ofir.dk/statistic/register?context=JobApplicationInitiatedCount&feedId=dc2beb84&entryId=056f6eba&page=ShowJob&component=SendApplicationButtonhttps://dispatcher.ofir.dk/statistic/register?context=JobApplicationAppliedCount&feedId=dc2beb84&entryId=056f6eba&page=EmailApplyForm&component=SendApplicationButtonhttps://static.matchwork.com/company/logo/DK/ORS/SoMe/Oevrige/1.jpgEr du den nye Kvalitetsmedarbejder i NOVO NORDISK A/S?12007991Dansk3Læse/ tale315218Kvalitetsmedarbejder0Øvrige361844390noreply@ofir.comDKDanmarkDKDanmark330058137GCP Advisor Specialist for R&D QualityRobot Your opportunity Do you wish to use your solid GCP knowledge, process optimisation skills and quality mind-set in a highly professional and engaged global environment then you may be our new GCP Advisor Specialist? Being part of Novo Nordisk Research Development means working at one of the world s largest and most successful biopharmaceutical companies. Our R D organisation is vital to Novo Nordisk and now we offer a talented person with an interest in clinical quality and process optimisation the opportunity to join us. In Global Development, we take responsibility for new products based on proteins and peptides from early development phases to product introduction to the market. We are responsible for managing clinical drug development worldwide, securing that the process lives up to uniform global standards, regulations and business ethics. We work in a global setting with focus on delivering viable products that make a difference to patients and ultimately benefit society. About the department R D Quality is part of Global Development and is divided into three departments. The open position is as a GCP Advisor Specialist in the Global Clinical Research QMS department. The department is responsible for our Clinical QMS including all our CT-SOPs, GCP Advice, Medical Device support and QA function within R D and participation in cross organisational improvement projects in addition to general quality support to our global organisation. The job As a GCP Advisor Specialist you are responsible for developing and maintaining our quality management system, with a strong focus on GCP and compliance globally. In close collaboration with 14 colleagues, you will ensure that Novo Nordisk maintains one global clinical quality management system in compliance with GCP and other relevant external and internal requirements. You will be the GCP expert on the clinical SOPs in the SOP update process, provide GCP support to stakeholders and participate in cross-organisational improvement projects. You will be part of a dynamic department, where the position offers high impact and you will use your expertise to ensure overall compliance with relevant requirement by supporting stakeholders, including affiliate colleagues, in the organisation. You will be involved in stakeholder meetings and cross organisational improvement projects. Qualifications You have a degree in pharmacy, medicine, science or similar and a strong command of written and spoken English. You have at least 10 years of experience in clinical research and drug development, as well as solid knowledge of GCP and other relevant regulations. Experience within clinical quality assurance, trial management Monitoring, or GCP Audit is required. You take a pragmatic approach to problem solving and you are eager to optimise and simplify processes around you. You are proactive and have strong communication and interpersonal skills. You are organised, detail-oriented without losing the big picture and quality-conscious as well as curious by nature. You are a team player and you thrive working across departments in an international organisation. Working at Novo Nordisk At Novo Nordisk, we use our skills, dedication and ambition to help people with diabetes. We offer the chance to be part of a truly global work place, where passion and engagement are met with oppotunities for professional and personal development. Contact For further information, please contact Susanne Witzke at 45 3079 2273 (on vacation 11 7-31 7, but please leave a message, and your call will be returned when possible). Deadline 15 August 2019, however, we will be screening and interviewing on an ongoing basis. 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.

Your opportunity

Do you wish to use your solid GCP knowledge, process optimisation skills and quality mind-set in a highly professional and engaged global environment then you may be our new GCP Advisor Specialist? 

Being part of Novo Nordisk Research & Development means working at one of the world’s largest and most successful biopharmaceutical companies.

Our R&D organisation is vital to Novo Nordisk and now we offer a talented person with an interest in clinical quality and process optimisation the opportunity to join us. 

In Global Development, we take responsibility for new products based on proteins and peptides from early development phases to product introduction to the market. We are responsible for managing clinical drug development worldwide, securing that the process lives up to uniform global standards, regulations and business ethics. We work in a global setting with focus on delivering viable products that make a difference to patients and ultimately benefit society.

 

About the department

R&D Quality is part of Global Development and is divided into three departments. The open position is as a GCP Advisor Specialist in the Global Clinical & Research QMS department. The department is responsible for our Clinical QMS including all our CT-SOPs, GCP Advice, Medical Device support and QA function within R&D and participation in cross organisational improvement projects in addition to general quality support to our global organisation.


The job
As a GCP Advisor Specialist you are responsible for developing and maintaining our quality management system, with a strong focus on GCP and compliance globally.
In close collaboration with 14 colleagues, you will ensure that Novo Nordisk maintains one global clinical quality management system in compliance with GCP and other relevant external and internal requirements. You will be the GCP expert on the clinical SOPs in the SOP update process, provide GCP support to stakeholders and participate in cross-organisational improvement projects. You will be part of a dynamic department, where the position offers high impact and you will use your expertise to ensure overall compliance with relevant requirement by supporting stakeholders, including affiliate colleagues, in the organisation. You will be involved in stakeholder meetings and cross organisational improvement projects. 
 

Qualifications
You have a degree in pharmacy, medicine, science or similar and a strong command of written and spoken English. You have at least 10 years of experience in clinical research and drug development, as well as solid knowledge of GCP and other relevant regulations. Experience within clinical quality assurance, trial management/Monitoring, or GCP Audit is required.

You take a pragmatic approach to problem solving and you are eager to optimise and simplify processes around you. You are proactive and have strong communication and interpersonal skills. You are organised, detail-oriented without losing the big picture and quality-conscious as well as curious by nature. You are a team player and you thrive working across departments in an international organisation.

Working at Novo Nordisk

At Novo Nordisk, we use our skills, dedication and ambition to help people with diabetes. We offer the chance to be part of a truly global work place, where passion and engagement are met with oppotunities for professional and personal development.

 

Contact
For further information, please contact Susanne Witzke at +45 3079 2273 (on vacation 11/7-31/7, but please leave a message, and your call will be returned when possible).


Deadline
15 August 2019, however, we will be screening and interviewing on an ongoing basis.

 

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.

Novo Nordisk A/SSøborg2019-07-10T00:00:002019-08-15T00:00:00
330057353Regulatory Professional - GLP-1 DiabetesRobot Join Regulatory Affairs and become part of an exciting environment where engaged people are committed gaining approval of Novo Nordisk s medicines by regulatory authorities across the globe. Our people have a unique combination of scientific insight, patient focus, and the ability to navigate many agendas and stakeholders. That makes Regulatory Affairs a truly interesting and challenging place to work. About the department RA GLP-1 Diabetes are responsible regulatory activities for our key GLP-1 products that help patients with Type 2 diabetes and at the same time reduce the risk of cardiovascular disease. We work together with our stakeholders to ensure that labelling reflects strong scientific data and to continue to develop new GLP-1 based products that bring even better treatment to patients. We are seven dedicated and engaged employees working in the department. We work as an integrated part of the global research and development project and commercial teams. We are responsible for the regulatory strategy and provide regulatory expertise and tactics to the product development plan throughout the entire product lifecycle. We drive the global regulatory applications, label expansion, Health Authority interactions and clinical trial applications. We have a strong collaboration with our affiliates and work in global regulatory teams. We are currently looking for a Regulatory Professional with a is looking to take ownership of regulatory process across the all stages of the product lifecycle. The job As a regulatory professional you will be required to drive, coordinate and actively follow-up on several tasks with challenging and often overlapping timelines. You will be a member of cross functional project teams including study groups and teams responsible for deliverables during lifecycle management. You will interact with a variety of stakeholders from different departments and worldwide affiliates in Novo Nordisk. You will participate in the development of regulatory documentation to Health Authorities, including safety documents, variation applications, briefing packages for meetings with Health Authorities, clinical trial applications and clinical trial protocols . Other responsibilities include ensuring that regulatory commitments are met, promotional materials are aligned with our labelling and that Investigator initiated studies are in accordance with the regulatory strategy. You are expected to provide regulatory input, be proactive and challenge and contribute to project team decisions. You will also have the opportunity to contribute to projects for the improvement and maintenance of regulatory processes. Qualifications We expect you to have a university degree in science have 2-4 years of experience from the pharma industry. As a person you thrive in a busy environment bring can-do spirit and a healthy sense of humour to your work even when the pressure is on. You are a flexible and change-oriented person who focuses on opportunities rather than limitations in challenging situations. Working at Novo Nordisk At Novo Nordisk, we use our skills, dedication and ambition to help people with diabetes. We offer the chance to be part of a truly global work place, where passion and engagement are met with opportunities for professional and personal development. Contact For further information, please contact David Truloff on 45 30790499. Deadline 28. July 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.

Join Regulatory Affairs and become part of an exciting environment where engaged people are committed gaining approval of Novo Nordisk’s medicines by regulatory authorities across the globe. Our people have a unique combination of scientific insight, patient focus, and the ability to navigate many agendas and stakeholders. That makes Regulatory Affairs a truly interesting and challenging place to work.

 

About the department
RA GLP-1 Diabetes are responsible regulatory activities for our key GLP-1 products that help patients with Type 2 diabetes and at the same time reduce the risk of cardiovascular disease. We work together with our stakeholders to ensure that labelling reflects strong scientific data and to continue to develop new GLP-1 based products that bring even better treatment to patients. We are seven dedicated and engaged employees working in the department.

We work as an integrated part of the global research and development project and commercial teams. We are responsible for the regulatory strategy and provide regulatory expertise and tactics to the product development plan throughout the entire product lifecycle. We drive the global regulatory applications, label expansion, Health Authority interactions and clinical trial applications. We have a strong collaboration with our affiliates and work in global regulatory teams.

We are currently looking for a Regulatory Professional with a is looking to take ownership of regulatory process across the all stages of the product lifecycle.

 

The job
As a regulatory professional you will be required to drive, coordinate and actively follow-up on several tasks with challenging and often overlapping timelines.

You will be a member of cross functional project teams including study groups and  teams responsible for deliverables during lifecycle management. You will interact with a variety of stakeholders from different departments and worldwide affiliates in Novo Nordisk. You will participate in the development of regulatory documentation to Health Authorities, including safety documents, variation applications, briefing packages for meetings with Health Authorities, clinical trial applications and clinical trial protocols . Other responsibilities include ensuring that regulatory commitments are met, promotional materials are aligned with our labelling and that Investigator initiated studies are in accordance with the regulatory strategy. You are expected to provide regulatory input, be proactive and challenge and contribute to project team decisions.

You will also have the opportunity to contribute to projects for the improvement and maintenance of regulatory processes.

 

Qualifications

We expect you to have a university degree in science have 2-4 years of experience from the pharma industry.

As a person you thrive in a busy environment; bring can-do spirit and a healthy sense of humour to your work – even when the pressure is on. You are a flexible and change-oriented person who focuses on opportunities rather than limitations in challenging situations.

 

Working at Novo Nordisk

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

 

Contact

For further information, please contact David Truloff on +45 30790499.

 

Deadline

28. July 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.

Novo Nordisk A/SSøborg2019-07-09T00:00:002019-07-28T00:00:00
330057339Regulatory Professional - Long-acting Insulin ProjectsRobot Join Regulatory Affairs and become part of an exciting environment where engaged people are committed gaining approval of Novo Nordisk s medicines by regulatory authorities across the globe. Our people have a unique combination of scientific insight, patient focus, and the ability to navigate many agendas and stakeholders. That makes Regulatory Affairs a truly interesting and challenging place to work. About the department RA Long-acting Insulins Projects are responsible for the clinical long-acting insulin development projects as well as the clinical Life Cycle Management activities for marketed long-acting insulin products. We are nine dedicated and highly engaged employees working in the department. We work as an integrated part of the global development and research project teams and cross-functional sub-teams. We are responsible for the regulatory strategies and provide regulatory expertise and tactics to the product development plan. We drive label development, Health Authority interactions and clinical trial applications. We have a strong collaboration with our affiliates and work in global regulatory teams. We are currently looking for a Regulatory Professional with a scientific background and a genuine interest in being part of the future within Long-acting Insulin Projects. The job As a regulatory professional you will be required to drive, coordinate and actively follow-up on several tasks with challenging and often overlapping timelines. You will be a member of cross functional project teams including study groups and submission teams, and as such, interact with a variety of stakeholders from different departments in Novo Nordisk. You will participate in the development of regulatory documentation for submission to Health Authorities, including briefing packages for meetings with Health Authorities, clinical trial applications, clinical trial protocols and reports and regulatory file for marketing authorisation. Furthermore, you will be expected to provide regulatory input, be proactive, challenge the discussions and contribute to project team decisions. You will among others interact with medical and non-clinical specialists, statisticians and medical writers. You will also have the opportunity to contribute to projects for the improvement and maintenance of regulatory processes across the organisation. Qualifications We expect you to have a Master of Science (life sciences) and or PhD with some relevant working experience (3-4 years). As a person you thrive in a busy environment bring a can-do spirit and a healthy sense of humour to your work even when the pressure is on. You are a flexible and change-oriented person who focuses on opportunities rather than limitations in challenging situations. Working at Novo Nordisk At Novo Nordisk, we use our skills, dedication and ambition to help people with diabetes. We offer the chance to be part of a truly global work place, where passion and engagement are met with opportunities for professional and personal development. Contact For further information, please contact Louise Buchholt Johansen on 45 30 79 13 81. Deadline 28 July 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.

Join Regulatory Affairs and become part of an exciting environment where engaged people are committed gaining approval of Novo Nordisk’s medicines by regulatory authorities across the globe. Our people have a unique combination of scientific insight, patient focus, and the ability to navigate many agendas and stakeholders. That makes Regulatory Affairs a truly interesting and challenging place to work.

 

About the department

RA Long-acting Insulins Projects are responsible for the clinical long-acting insulin development projects as well as the clinical Life Cycle Management activities for marketed long-acting insulin products. We are nine dedicated and highly engaged employees working in the department.

We work as an integrated part of the global development and research project teams and cross-functional sub-teams. We are responsible for the regulatory strategies and provide regulatory expertise and tactics to the product development plan. We drive label development, Health Authority interactions and clinical trial applications. We have a strong collaboration with our affiliates and work in global regulatory teams.

We are currently looking for a Regulatory Professional with a scientific background and a genuine interest in being part of the future within Long-acting Insulin Projects.

 

The job

As a regulatory professional you will be required to drive, coordinate and actively follow-up on several tasks with challenging and often overlapping timelines.

You will be a member of cross functional project teams including study groups and submission teams, and as such, interact with a variety of stakeholders from different departments in Novo Nordisk. You will participate in the development of regulatory documentation for submission to Health Authorities, including briefing packages for meetings with Health Authorities, clinical trial applications, clinical trial protocols and reports and regulatory file for marketing authorisation. Furthermore, you will be expected to provide regulatory input, be proactive, challenge the discussions and contribute to project team decisions. You will among others interact with medical and non-clinical specialists, statisticians and medical writers.

You will also have the opportunity to contribute to projects for the improvement and maintenance of regulatory processes across the organisation.

 

Qualifications

We expect you to have a Master of Science (life sciences) and/or PhD with some relevant working experience (3-4 years). As a person you thrive in a busy environment; bring a can-do spirit and a healthy sense of humour to your work – even when the pressure is on. You are a flexible and change-oriented person who focuses on opportunities rather than limitations in challenging situations.

 

Working at Novo Nordisk

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

 

Contact

For further information, please contact Louise Buchholt Johansen on +45 30 79 13 81.

 

Deadline

28 July 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.

Novo Nordisk A/SSøborg2019-07-09T00:00:002019-07-28T00:00:00
330057334Safety Surveillance Specialist for Signal Management, Big data & Digital healthRobot Do you like to be a driving force in devising and implementing the signal management and big data analysis strategy for one of the most skilled and advanced pharmacovigilance functions in Denmark? If you are motivated to be part of bringing innovation in data analysis and signal detection, then you may be our new colleague. About the department Safety Surveillance Biopharm Diabetes, Insulin Devices is a department within Global Safety and is situated in Bagsværd, Denmark. Global Safety is an organisation of more than 400 highly professional people with an educational background primarily within life sciences. In our department we are more than 20 highly skilled pharmacovigilance experts having global responsibility for the signal detection and surveillance of all safety information for Novo Nordisk s products that are currently marketed or under development in Biopharm, Diabetes Insulins and Devices portfolio. Within the department, we have the device surveillance vigilance team dedicated to safety data monitoring of NN Medical Devices and Digital Health portfolio. The position You will play an important role in supporting the organization in building the big data and signal management strategy and will primarily be responsible for continuous improvement of methods and processes for the identification and evaluation of safety signals including development implementation of safety data analysis strategies. You will be participating cross functional study groups for big data and digital health activities and responsible for providing the input for safety surveillance strategy and support thereof. You will also be responsible for providing input to advanced analytics possibilities for signal management using big data and optimize the utilization of external safety databases for safety surveillance support. Furthermore, you will establish liaison with internal stakeholders in global development including data science epidemiology department to develop and maintain overview of relevant databases and develop strategy and process for digital pharmacovigilance and signal management. You will get the opportunity both to work independently or within a team of highly skilled, committed and enthusiastic colleagues. Assuming responsibility, clear communication and taking action will be essential parts of your work day. Qualifications You must have a university degree in life or data science preferably supplemented with documented scientific training (e.g. PhD) in data science epidemiology and you holds solid experience within data analysis using big data analysis methodologies and good understanding of advance data analytics, data evaluation. You will be able to contribute with knowledge about pharmacovigilance and safety signal detection management and you work with excellent problem solving skills Good oral and written communication competence in English (company language). Experience with working in multicultural teams is a plus and you are an experience user of MS Office user As a person you must have high ethical standards, you are responsible, well-organised and a strong communicator with an ability to adapt and drive constant change for continuous improvement. You are able to work under pressure when needed and able to make independent decisions regarding patient safety issues. You thrive in a multicultural environment of continuous development and you are good at establishing contact, collaborating and communicating with stakeholders. You are a strong driver and a dedicated team player and enjoy supporting and challenging your colleagues. Working at Novo Nordisk At Novo Nordisk your skills, commitment and ambition help us change lives for diabetes patients for the better. In exchange, we offer you a chance to work with extraordinary talent and to develop professionally and personally. Contact For further information, please contact Wasim Anwar at 45 3079 6766. Deadline 21 July 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.

Do you like to be a driving force in devising and implementing the signal management and big data analysis strategy for one of the most skilled and advanced pharmacovigilance functions in Denmark? If you are motivated to be part of bringing innovation in data analysis and signal detection, then you may be our new colleague.

 

About the department

Safety Surveillance Biopharm Diabetes, Insulin & Devices is a department within Global Safety and is situated in Bagsværd, Denmark. Global Safety is an organisation of more than 400 highly professional people with an educational background primarily within life sciences. In our department we are more than 20 highly skilled pharmacovigilance experts having global responsibility for the signal detection and surveillance of all safety information for Novo Nordisk’s products that are currently marketed or under development in Biopharm, Diabetes Insulins and Devices portfolio. 

Within the department, we have the device surveillance/ vigilance team dedicated to safety data monitoring of NN Medical Devices and Digital Health portfolio.

 

The position

You will play an important role in supporting the organization in building the big data and signal management strategy and will primarily be responsible for continuous improvement of methods and processes for the identification and evaluation of safety signals including development/ implementation of safety data analysis strategies. You will be participating cross functional study groups for big data and digital health activities and responsible for providing the input for safety surveillance strategy and support thereof. 

You will also be responsible for providing input to advanced analytics possibilities for signal management using big data and optimize the utilization of external safety databases for safety surveillance support. Furthermore, you will establish liaison with internal stakeholders in global development including data science/epidemiology department to develop and maintain overview of relevant databases and develop strategy and process for digital pharmacovigilance and signal management.

You will get the opportunity both to work independently or within a team of highly skilled, committed and enthusiastic colleagues. Assuming responsibility, clear communication and taking action will be essential parts of your work day.

 

Qualifications

You must have a university degree in life or data science preferably supplemented with documented scientific training (e.g. PhD) in data science/ epidemiology and you holds solid experience within data analysis using big data analysis methodologies and good understanding of advance data analytics, data evaluation. 

You will be able to contribute with knowledge about pharmacovigilance and safety signal detection/management and you work with excellent problem solving skills 

Good oral and written communication competence in English (company language). Experience with working in multicultural teams is a plus and you are an experience user of MS Office user 

As a person you must have high ethical standards, you are responsible, well-organised and a strong communicator with an ability to adapt and drive constant change for continuous improvement. You are able to work under pressure when needed and able to make independent decisions regarding patient safety issues. 

You thrive in a multicultural environment of continuous development and you are good at establishing contact, collaborating and communicating with stakeholders. You are a strong driver and a dedicated team player and enjoy supporting and challenging your colleagues.

 

Working at Novo Nordisk

At Novo Nordisk your skills, commitment and ambition help us change lives for diabetes patients for the better. In exchange, we offer you a chance to work with extraordinary talent and to develop professionally and personally.

 

Contact

For further information, please contact Wasim Anwar at +45 3079 6766.

 

Deadline

21 July 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.

NOVO NORDISK A/SBagsværd2019-07-09T00:00:002019-07-21T00:00:00
330058552Principal Safety Advisor for Global Safety SurveillanceRobot Do you want to work with drug safety in clinical development? As Senior Safety Advisor you will be a key player in the safety surveillance and development of one of LEO Pharma s new biologics Tralokinumab for the treatment of atopic dermatitis. You will become part of a team of 6 Safety Advisors working with an investigational, fully human monoclonal antibody for the treatment of moderate-to-severe atopic dermatitis. The product specifically blocks the effects of the cytokine IL-13, which plays an important role in the pathophysiology of atopic dermatitis one of the most common chronic, inflammatory skin diseases. LEO Pharma s ambitions LEO Pharma has embarked on a growth journey to become the preferred dermatology care partner in the world, dedicated to help people achieve healthy skin. We have recently introduced our 2025 strategy, which aims to accelerate our efforts in innovative therapeutics while strengthening our established portfolio and our global footprint in medical dermatology. Dermatology is an area of rapid growth and LEO Pharma is rapidly changing from primarily focusing on topical treatments, to being at the forefront of scientific advancements to help patients. Job description We are offering a job with considerable individual responsibility, challenges, and the opportunity to develop your professional and personal competencies. As Principle Safety Advisor, your focus is to be globally responsible for effective safety risk management processes with main tasks including but not limited to: Leading safety management teams Assisting with establishing and developing consistent safety risk management practices across projects, processes and documents Signal detection and management Participation in clinical trial teams providing safety input to clinical development discussions and documents, e.g. trial protocols and Investigator s Brochure Preparation of safety input to various regulatory documents Preparation of DSURs and Periodic line listings to the authorities Medical assessment of SAEs SUSARs Qualifications University degree in health or biological science (MD, MSc, MSc Pharm, or equivalent) 5 years of experience from the pharmaceutical industry in pharmacovigilance drug safety departments and or medical clinical development A solid understanding of medical concepts, disease processes, scientific methodology, drug development and data analysis is very important, documented scientific training (e.g. PhD) and experience from interactions with regulatory authorities will be an additional advantage A proactive and open-minded approach Since the job involves multiple tasks with fixed deadlines ongoing at the same time, the ability to focus, stay calm and work independently as well as in teams, is a necessity Strong collaboration skills and experience from working in cross functional teams An analytical mindset and an eye for detail Good and strong written and verbal English skills We are a dedicated and ambitious team Global Safety Surveillance consists of 30 dynamic colleagues striving to safeguard our patients and to improve the quality of our processes and developing our competencies to meet the need of the patients and other stakeholders, internally as well as externally. We are driven by a high level of integrity, science, passion for our work and an open-minded approach. The position is placed in the LEO Pharma headquarters in Ballerup. For more information Please contact Head of Global Safety Surveillance Innovative, Søren Lindberg at 45 31233919. We look forward to reading your application Please send your application no later than 09-AUG-2019 EOB. Interviews will be held on an ongoing basis.

Do you want to work with drug safety in clinical development?

As Senior Safety Advisor you will be a key player in the safety surveillance and development of one of LEO Pharma’s new biologics Tralokinumab for the treatment of atopic dermatitis. You will become part of a team of 6 Safety Advisors working with an investigational, fully human monoclonal antibody for the treatment of moderate-to-severe atopic dermatitis. The product specifically blocks the effects of the cytokine IL-13, which plays an important role in the pathophysiology of atopic dermatitis – one of the most common chronic, inflammatory skin diseases.

LEO Pharma’s ambitions

LEO Pharma has embarked on a growth journey to become the preferred dermatology care partner in the world, dedicated to help people achieve healthy skin. We have recently introduced our 2025 strategy, which aims to accelerate our efforts in innovative therapeutics while strengthening our established portfolio and our global footprint in medical dermatology. Dermatology is an area of rapid growth and LEO Pharma is rapidly changing from primarily focusing on topical treatments, to being at the forefront of scientific advancements to help patients.

Job description

We are offering a job with considerable individual responsibility, challenges, and the opportunity to develop your professional and personal competencies. As Principle Safety Advisor, your focus is to be globally responsible for effective safety risk management processes with main tasks including but not limited to:

  • Leading safety management teams
  • Assisting with establishing and developing consistent safety risk management practices across projects, processes and documents
  • Signal detection and management
  • Participation in clinical trial teams providing safety input to clinical development discussions and documents, e.g. trial protocols and Investigator’s Brochure
  • Preparation of safety input to various regulatory documents
  • Preparation of DSURs and Periodic line listings to the authorities
  • Medical assessment of SAEs/SUSARs

Qualifications

  • University degree in health or biological science (MD, MSc, MSc Pharm, or equivalent)
  • 5+ years of experience from the pharmaceutical industry in pharmacovigilance/drug safety departments and/or medical/clinical development
  • A solid understanding of medical concepts, disease processes, scientific methodology, drug development and data analysis is very important, documented scientific training (e.g. PhD) and experience from interactions with regulatory authorities will be an additional advantage
  • A proactive and open-minded approach
  • Since the job involves multiple tasks with fixed deadlines ongoing at the same time, the ability to focus, stay calm and work independently as well as in teams, is a necessity
  • Strong collaboration skills and experience from working in cross functional teams
  • An analytical mindset and an eye for detail
  • Good and strong written and verbal English skills

We are a dedicated and ambitious team

Global Safety Surveillance consists of 30+ dynamic colleagues striving to safeguard our patients and to improve the quality of our processes and developing our competencies to meet the need of the patients and other stakeholders, internally as well as externally. We are driven by a high level of integrity, science, passion for our work and an open-minded approach.

The position is placed in the LEO Pharma headquarters in Ballerup.

For more information

Please contact Head of Global Safety Surveillance Innovative, Søren Lindberg at +45 31233919.

We look forward to reading your application

Please send your application no later than 09-AUG-2019 EOB
Interviews will be held on an ongoing basis.

LEO PHARMA A/SBallerup2019-07-11T00:00:002019-08-09T00:00:00
da-DK

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