Regulatory Writer
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Bagsværd
Do you want to have an impact on how we write regulatory submission documents for approval of new finished products? Do you thrive in an environment where you can ensure a smooth process and interaction with health authorities throughout a submission and Q&A process?
Then apply now to our Regulatory Writer role and join a team that will set the standards of regulatory submission documents for Novo Nordisk growing pipeline of new injectable drug products.
The position
We are now hiring a full-time writer who will be strongly involved in defining the cross-department collaboration going forward.
You can look forward to: Defining and keeping the overview of the regulatory storyline
Creating documentation for our portfolio to ensure that the required product's quality is fulfilled and thereby, securing patients’ safety
Reviewing and implementing new documentation defining specifications, shelf-life stability studies, risk assessments, as well as regulatory submission documents to health authorities
Using your regulatory expertise to provide feedback, secure answers to questions from various health authorities and keeping in touch with them
Structuring and coordination of a complex documentation and submissions portfolio
You will do this in cooperation with your colleagues across two departments in Injectable Finished Products (IFP) Manufacturing Development, in the Development departments (CMC), QC, QA, Production, and in Regulatory Affairs.
We offer an exciting and engaging job that requires initiative, collaboration skills and flexibility.
Qualifications
The qualifications we will be looking for, are: An academic degree in Science within Pharmacy, Chemistry, Engineering, or a similar field
Experience either from the pharmaceutical industry, the regulatory area or from the health authorities with either writing or reviewing regulatory documents
Excellent ability to plan and coordinate the writing work in line with an ambitious submission strategy
Proficiency in creating an overview and prioritizing tasks; even when deadline approaches
Great communication skills in English, both spoken and written
As a person, you do well in busy environments, challenges do not scare you, and a quality mindset is at your core. Time management is well appreciated, as well as being an engaged team player.
About the department
In IFP Manufacturing Development we are responsible for the specifications of finished products and transfer of products from Chemistry, Manufacturing and Control (CMC) to our production facilities in Product Supply (PS) and the support of our aseptic productions. Further, we seek innovative solutions to and optimizations of all our processes and write the associated documents to authorities worldwide plus answering Q&A’s.
The Regulatory Writer will have their base in Portfolio and New Products (PNP) which is part of IFP Manufacturing development. PNP is responsible for launch of all new drug products and works closely with Site Support and Improvement, which secures submissions of already marketed drug products. The regulatory writer will be allocated to a drug product and work across the two mentioned departments, so the role will, to a high extent, tie the two departments, and particularly the regulatory thread throughout the submission.
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 call Senior Manager, Maria Berggård Silow at +45-34485056
Deadline
31 March 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.
Then apply now to our Regulatory Writer role and join a team that will set the standards of regulatory submission documents for Novo Nordisk growing pipeline of new injectable drug products.
The position
We are now hiring a full-time writer who will be strongly involved in defining the cross-department collaboration going forward.
You can look forward to:
You will do this in cooperation with your colleagues across two departments in Injectable Finished Products (IFP) Manufacturing Development, in the Development departments (CMC), QC, QA, Production, and in Regulatory Affairs.
We offer an exciting and engaging job that requires initiative, collaboration skills and flexibility.
Qualifications
The qualifications we will be looking for, are:
As a person, you do well in busy environments, challenges do not scare you, and a quality mindset is at your core. Time management is well appreciated, as well as being an engaged team player.
About the department
In IFP Manufacturing Development we are responsible for the specifications of finished products and transfer of products from Chemistry, Manufacturing and Control (CMC) to our production facilities in Product Supply (PS) and the support of our aseptic productions. Further, we seek innovative solutions to and optimizations of all our processes and write the associated documents to authorities worldwide plus answering Q&A’s.
The Regulatory Writer will have their base in Portfolio and New Products (PNP) which is part of IFP Manufacturing development. PNP is responsible for launch of all new drug products and works closely with Site Support and Improvement, which secures submissions of already marketed drug products. The regulatory writer will be allocated to a drug product and work across the two mentioned departments, so the role will, to a high extent, tie the two departments, and particularly the regulatory thread throughout the submission.
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 call Senior Manager, Maria Berggård Silow at +45-34485056
Deadline
31 March 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 22.3.2024, 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.
- Øvrige
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