Submission (Senior) Project Managers
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Søborg
Do you want to lead submission projects and have an impact on how we organize regulatory submission work of new and established products? Would you like to join an environment where you can collaborate with Regulatory Affairs department throughout a submission and Q&A process?
If so, apply now to our Submission (Senior) Project Managers role and join a team that will set the standards of regulatory submission documents for Novo Nordisk’s growing pipeline of new injectable drug products.
The position We are looking for Submission (Senior) Project Managers to join our office in Søborg and become responsible for managing submission projects and actively contributing to the ongoing development of our approach to regulatory processes in the specified area. Your responsibilities will include: Executing submission projects (NDA’s, MMA’s, and CTA’s,) on new and established products together with your team of regulatory writers and process experts
Defining and keeping the overview of the regulatory storyline together with Regulatory Affairs department
Securing answers to questions from various health authorities in collaboration with the Subject Matter Experts
Structuring and coordinating complex documentation and submissions portfolio
Identifying and implementing new tools and ways of working to simplify and streamline submissions for new and existing products
Moreover, in this role you will have a great opportunity to cooperate with your colleagues across various departments in Injectable Finished Products (IFP) Manufacturing Development: the development departments (CMC), QC, QA, production, and in Regulatory Affairs.
We offer an exciting and stimulating job that requires great energy, initiative, collaboration skills and flexibility.
Qualifications
To succeed in this role, you have: An Academic Degree in Science, Pharmacy, Chemistry, Engineering, or a similar field
Experience either from the pharmaceutical industry, the regulatory area or from the health authorities in writing or reviewing regulatory documents
Project management experience within pharmaceutical-, regulatory affairs-, or similar areas
Ability to set the direction for building a regulatory submissions competence and collaboration hub in Novo Nordisk Product Supply
Professional proficiency in written and spoken English
On a personal level, you do well in busy and dynamic environments; challenges do not scare you, and a quality mindset is at your core. You have a strong appreciation for time management and actively engage as a team player. Your ability to create an overview and prioritize tasks, particularly under tight deadlines, is commendable. Additionally, you exhibit proactivity and effective communication with various stakeholders. Your enthusiasm for learning and developing new skills is evident. Please note that we are actively seeking Submission Project Managers at different levels of seniority. Therefore, we encourage candidates with varying years of experience to apply.
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 Submission (Senior) Project Managers will have their base in IFP ManDev – Site Support & Improvements, which is responsible for the production processes and marketed products in our production network.
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 reach out to Senior Manager, Søren Alvarez Utoft, +45 30759981 Deadline
21 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.
If so, apply now to our Submission (Senior) Project Managers role and join a team that will set the standards of regulatory submission documents for Novo Nordisk’s growing pipeline of new injectable drug products.
The position We are looking for Submission (Senior) Project Managers to join our office in Søborg and become responsible for managing submission projects and actively contributing to the ongoing development of our approach to regulatory processes in the specified area. Your responsibilities will include:
Moreover, in this role you will have a great opportunity to cooperate with your colleagues across various departments in Injectable Finished Products (IFP) Manufacturing Development: the development departments (CMC), QC, QA, production, and in Regulatory Affairs.
We offer an exciting and stimulating job that requires great energy, initiative, collaboration skills and flexibility.
Qualifications
To succeed in this role, you have:
On a personal level, you do well in busy and dynamic environments; challenges do not scare you, and a quality mindset is at your core. You have a strong appreciation for time management and actively engage as a team player. Your ability to create an overview and prioritize tasks, particularly under tight deadlines, is commendable. Additionally, you exhibit proactivity and effective communication with various stakeholders. Your enthusiasm for learning and developing new skills is evident. Please note that we are actively seeking Submission Project Managers at different levels of seniority. Therefore, we encourage candidates with varying years of experience to apply.
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 Submission (Senior) Project Managers will have their base in IFP ManDev – Site Support & Improvements, which is responsible for the production processes and marketed products in our production network.
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 reach out to Senior Manager, Søren Alvarez Utoft, +45 30759981 Deadline
21 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 "Projektleder", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 5.1.2024, 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.
- Projektleder
- Søborg
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