Regulatory Writer
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Are you a skilled scientific writer with a passion for regulatory documentation? Novo Nordisk’s Analytical Competence Centre is looking for a talented Regulatory Writer to support our diverse team and collaborate across multiple departments. Apply today and join our team! The position
As a Regulatory Writer in the Analytical Competence Centre, you will be an integral part of supporting the department.
You will interact with a wide range of stakeholders, e.g., drug product development, areas within Aseptic Manufacturing Science and Technology, Regulatory Affairs, Quality Control and Quality Assurance. Your key responsibilities include:
• Collaborate on the development of regulatory documentation following established guidelines and SOPs.
• Plan content creation and establish timelines for document production and review.
• Evaluate documents for coherence, precision, scientific rigor, and consistent information and messaging.
• Actively engage in improving best practices and innovating the way we work.
• Maintain an updated understanding of essential regulatory and scientific subjects pertinent to the analytical aspects of drug development.
Qualification
To fulfill this role, you ideally have:
• A Master’s degree within natural sciences.
• Demonstrated ability to produce clear, high-quality scientific writing in the English language.
• Experience authoring documentation for Health Authorities.
• Experience working in a GMP-regulated environment.
• Ability to work effectively on cross-functional, geographically diverse teams, establishing strong collaborative relationships
• Project management skills, allowing you to consistently achieve multiple tasks and goals on-time
In addition to the technical skills, we value personal contributions and teamwork. Therefore, we are looking for someone who can independently analyse and challenge the status quo. The candidate should also have strong interpersonal, verbal, and written communication skills, be proficient in English.
Furthermore, the ideal candidate should be able to work independently with a positive can-do attitude, think through problems clearly and logically, and adapt to changing conditions. At Novo Nordisk, we value both hard and soft skills, and we believe that the right candidate should possess a combination of both to maintain a good work environment.
About the department The Analytical Competence Centre is a department in Aseptic Manufacturing (AM) Science And Technology (AMSAT) and consists of 65 employees organised in 5 teams. We have a central support function in relation to chemical analysis of Novo Nordisk injectable finished products under development, as well as our marketed products. The department is responsible for validation of analytical methods for late-phase development and market products and thereafter for the following transfer of the analytical methods to our QC laboratories across the world. Furthermore, the department is scouting, testing, and implementing fast analytical techniques that can reduce the lead time for analysis with the ambitious long-term goal of real time release testing of injectable finished products. Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care.
Contact
For further information, please contact Markus Kaldan Back, Senior Manager on +45 30750510
Deadline 11 August, 2024. 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.
As a Regulatory Writer in the Analytical Competence Centre, you will be an integral part of supporting the department.
You will interact with a wide range of stakeholders, e.g., drug product development, areas within Aseptic Manufacturing Science and Technology, Regulatory Affairs, Quality Control and Quality Assurance. Your key responsibilities include:
• Collaborate on the development of regulatory documentation following established guidelines and SOPs.
• Plan content creation and establish timelines for document production and review.
• Evaluate documents for coherence, precision, scientific rigor, and consistent information and messaging.
• Actively engage in improving best practices and innovating the way we work.
• Maintain an updated understanding of essential regulatory and scientific subjects pertinent to the analytical aspects of drug development.
Qualification
To fulfill this role, you ideally have:
• A Master’s degree within natural sciences.
• Demonstrated ability to produce clear, high-quality scientific writing in the English language.
• Experience authoring documentation for Health Authorities.
• Experience working in a GMP-regulated environment.
• Ability to work effectively on cross-functional, geographically diverse teams, establishing strong collaborative relationships
• Project management skills, allowing you to consistently achieve multiple tasks and goals on-time
In addition to the technical skills, we value personal contributions and teamwork. Therefore, we are looking for someone who can independently analyse and challenge the status quo. The candidate should also have strong interpersonal, verbal, and written communication skills, be proficient in English.
Furthermore, the ideal candidate should be able to work independently with a positive can-do attitude, think through problems clearly and logically, and adapt to changing conditions. At Novo Nordisk, we value both hard and soft skills, and we believe that the right candidate should possess a combination of both to maintain a good work environment.
About the department The Analytical Competence Centre is a department in Aseptic Manufacturing (AM) Science And Technology (AMSAT) and consists of 65 employees organised in 5 teams. We have a central support function in relation to chemical analysis of Novo Nordisk injectable finished products under development, as well as our marketed products. The department is responsible for validation of analytical methods for late-phase development and market products and thereafter for the following transfer of the analytical methods to our QC laboratories across the world. Furthermore, the department is scouting, testing, and implementing fast analytical techniques that can reduce the lead time for analysis with the ambitious long-term goal of real time release testing of injectable finished products. Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care.
Contact
For further information, please contact Markus Kaldan Back, Senior Manager on +45 30750510
Deadline 11 August, 2024. 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 "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Bagsværd.
Jobbet er oprettet på vores service den 26.7.2024, 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.
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