Senior Analytical Project Manager
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Gentofte
Are you ready to apply your project management experience and analytical skills in an exciting organization, where you will get challenged, grow, and expand your capabilities to the fullest? Do you want to work with the Chinese authorities and market and be a part of the development of future drugs and make a difference for patients living with rare diseases? Then apply today and join our team! The position
As Senior Analytical Project Manager you will play a key role in leading analytical activities across the Biotech and Rare Disease Portfolio for the Chinese market. You will be responsible for coordinating submissions of analytical regulatory documents to the Chinese authorities for the entire BRD portfolio. You will also be responsible for interacting with the Chinese affiliate and supporting the QC import analysis done by the Chinese authorities. You will interact with a wide variety of stakeholders such as technical project leads (for e.g., drug product), CMC, Quality Assurance, Regulatory Affairs, and representatives from Quality Control departments. Furthermore, you will collaborate with analytical professionals within our department who are working hands-on with method development, new technology and regulatory writing. In this role you will be responsible for aligning the needs of the project organisation with those in line of business. You will work closely with stakeholders across the organisation regarding both planning and execution, and in resolving concrete scientific challenges. All of this require clear and timely communication of project requirements to team and department members. Finally, you will join a harmonious team and department with competent, caring, and positive colleagues. We have a strong foundation of employees with high seniority mixed with more recent newcomers. Novo Nordisk is a great place to work, and our internal engagement survey scores are well above average. Qualifications
To succeed in this position, you have:
• A relevant academic degree within Pharmacy, Chemistry, or similar.
• +2 years of experience in managing and executing smaller and larger projects.
• Experience in leading analytical activities in either early phase and/or late phase clinical development.
• Scientific experience within analytical development and experience with regulatory submissions will be an advantage.
• Experience in working with the Chinese authorities will be an advantage.
• Full professional proficiency in English. As a person, you enjoy working on both short and long-term projects in implementing new products and processes. You are naturally good at communicating with all types of stakeholders both verbally and in writing. This helps you to keep all your stakeholders aligned, informed, and engaged. You are motived by the opportunity of getting a large network in and across our area. About the department
BRD Manufacturing Development & Quality Control has its base in Denmark. What other companies call Manufacturing Science & Analytical Technology (MSAT) we call Manufacturing Development. We are app. 460 colleagues who are the end-to-end station for product and process development for all BRD production facilities, driving innovation both when it comes to industry 4.0 technology and expansion of the product portfolio. Our area also includes the Quality Control unit for all BRD’s products. Together we drive change by always looking for improvements within our processes and in the way we work to make our products reach as many patients as possible. Working at BRD, Novo Nordisk
BRD is part of Novo Nordisk Product Supply, which is a global production network at the forefront of technology and in quality production of pharmaceutical products. In BRD we are not only supplying all Novo Nordisk products for Rare Diseases, but also using our competences in Biotech to support the growing efforts into completely new production platforms and therapy areas for Novo Nordisk. We are app. 2500 colleagues committed to drive change for people with serious chronic diseases. We produce our life-saving medicines out of five state-of-the-art production sites in Denmark and United States - covering the entire production value chain where raw materials are cultivated, purified, formulated, filled, assembled in devices, packed, and distributed across the globe. Not only are we making a difference for patients – we are also striving to make a difference for our employees by promoting a learning culture with high level of trust, innovation, and development for everyone. Are you ready for a life-changing career? Contact
For further information about the position, please contact Associate Manager Julie Kruse Jensen at +45 30 77 50 11. Deadline
19 of March 2023. Please apply as soon as possible as we will be conducting interviews 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.
As Senior Analytical Project Manager you will play a key role in leading analytical activities across the Biotech and Rare Disease Portfolio for the Chinese market. You will be responsible for coordinating submissions of analytical regulatory documents to the Chinese authorities for the entire BRD portfolio. You will also be responsible for interacting with the Chinese affiliate and supporting the QC import analysis done by the Chinese authorities. You will interact with a wide variety of stakeholders such as technical project leads (for e.g., drug product), CMC, Quality Assurance, Regulatory Affairs, and representatives from Quality Control departments. Furthermore, you will collaborate with analytical professionals within our department who are working hands-on with method development, new technology and regulatory writing. In this role you will be responsible for aligning the needs of the project organisation with those in line of business. You will work closely with stakeholders across the organisation regarding both planning and execution, and in resolving concrete scientific challenges. All of this require clear and timely communication of project requirements to team and department members. Finally, you will join a harmonious team and department with competent, caring, and positive colleagues. We have a strong foundation of employees with high seniority mixed with more recent newcomers. Novo Nordisk is a great place to work, and our internal engagement survey scores are well above average. Qualifications
To succeed in this position, you have:
• A relevant academic degree within Pharmacy, Chemistry, or similar.
• +2 years of experience in managing and executing smaller and larger projects.
• Experience in leading analytical activities in either early phase and/or late phase clinical development.
• Scientific experience within analytical development and experience with regulatory submissions will be an advantage.
• Experience in working with the Chinese authorities will be an advantage.
• Full professional proficiency in English. As a person, you enjoy working on both short and long-term projects in implementing new products and processes. You are naturally good at communicating with all types of stakeholders both verbally and in writing. This helps you to keep all your stakeholders aligned, informed, and engaged. You are motived by the opportunity of getting a large network in and across our area. About the department
BRD Manufacturing Development & Quality Control has its base in Denmark. What other companies call Manufacturing Science & Analytical Technology (MSAT) we call Manufacturing Development. We are app. 460 colleagues who are the end-to-end station for product and process development for all BRD production facilities, driving innovation both when it comes to industry 4.0 technology and expansion of the product portfolio. Our area also includes the Quality Control unit for all BRD’s products. Together we drive change by always looking for improvements within our processes and in the way we work to make our products reach as many patients as possible. Working at BRD, Novo Nordisk
BRD is part of Novo Nordisk Product Supply, which is a global production network at the forefront of technology and in quality production of pharmaceutical products. In BRD we are not only supplying all Novo Nordisk products for Rare Diseases, but also using our competences in Biotech to support the growing efforts into completely new production platforms and therapy areas for Novo Nordisk. We are app. 2500 colleagues committed to drive change for people with serious chronic diseases. We produce our life-saving medicines out of five state-of-the-art production sites in Denmark and United States - covering the entire production value chain where raw materials are cultivated, purified, formulated, filled, assembled in devices, packed, and distributed across the globe. Not only are we making a difference for patients – we are also striving to make a difference for our employees by promoting a learning culture with high level of trust, innovation, and development for everyone. Are you ready for a life-changing career? Contact
For further information about the position, please contact Associate Manager Julie Kruse Jensen at +45 30 77 50 11. Deadline
19 of March 2023. Please apply as soon as possible as we will be conducting interviews 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.
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Jobbet er oprettet på vores service den 22.2.2023, men kan have været deaktiveret og genaktiveret igen.
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