Do you have a strong background in non-clinical activities? We are looking for a Non-Clinical Expert to join our team at Novo Nordisk. If you are ready to contribute to the development, submission, and approval of new drugs/devices, and have a passion for maintaining existing products, then read on and apply today for a life-changing career
About the department
Novo Nordisk is a global healthcare company with more than 100 years of innovation and supervision in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat serious chronic diseases.
Non-clinical Expert works within the Clinical Department but will be in charge of non-clinical activities on development, submission and approval of new drugs/devices, and maintenance of existing products through generation of documentation with sufficient quality aligned with local non-clinical requirements and other external and internal guidelines.
The position
As a Non-Clinical expert, you will ensure the high-quality preparation of J-CTD (M.2.4. and 2.6) in collaboration with HQ. While most modules are Japanese translations of HQ's CTD, you must thoroughly have knowledge on each module's content and verify its accuracy. Module M2.6.2 is prepared by Novo Nordisk Japan or outsourced based on study reports. Additionally, you'll be tasked with preparing high-quality responses to inquiries from PMDA (Pharmaceuticals and Medical Devices Agency) in partnership with HQ, requiring accurate understanding and communication of inquiries to HQ, though the majority of responses are prepared by them.
Other role expectations include:
Qualifications
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
Upload your CV to our online career page (click on Apply and follow the instructions).
Deadline
Until the completion of recruitment.
Applications will be screened on an ongoing basis, so you are encouraged to apply as soon as possible.
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.
#LI-AMS1
-
Chiyoda City Novo NordiskAre you interested in improving the lives of millions of people, contributing to a company that works with innovation and is a pioneer in addressing the unmet medical needs? Do you have an innovative mindset to drive change in a future-ready environment? If yes, this position of ...
-
Chiyoda City LivaNova PLC Full timeJoin us today and make a difference in people's lives · The Marketing Manager/Product Manager Neuromodulation is truly a Business Development Partner, expected to partner with our customers who are Neurosurgeon and Neurology. The incumbent will have the functional responsibility ...
-
Chiyoda City Bristol Myers Squibb Full timeDescription · : In support of Commercialization Strategy, the Associate Director of International Predictive Customer Engagement team develops and delivers analytical assessment, solution design and modeling capability relating to International market customer experience and eng ...
-
Chiyoda City RWE AG jobs.contract_type_full_time / jobs.contract_type_part_timeRWE Renewables Japan G.K., Tokyo · To start as soon as possible, full time / part time, permanent · Functional area: Legal / Compliance · We are looking for an experienced, highly motivated and self-confident Senior Legal Counsel supporting our fast-growing international RWE Offs ...
-
Chiyoda City Bristol Myers Squibb Full timeWorking with Us · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production li ...
-
Legal, Ethics
7日前
Chiyoda City Novo NordiskAre you a legal expert with a passion for ethics and compliance? Are you ready to make a difference in a global healthcare company? We are looking for a Legal, Ethics & Compliance Counsel to join our team at Novo Nordisk in Japan. If you are ready to utilize your expertise to ena ...
-
Chiyoda City Bristol Myers Squibb Full timeWorking with Us · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production li ...
-
Chiyoda City LivaNova PLC Full timeJoin us today and make a difference in people's lives · Position Summary - · The country Commercial Quality Specialist is part of the commercial organization. The main activities of this position are: · a. Designated Safety Manager for LivaNova Japan, in accordance with applicab ...
-
Nagoya HARMAN International Full timeHARMAN's engineers and designers are creative, purposeful and agile. As part of this team, you'll combine your technical expertise with innovative ideas to help drive cutting-edge solutions in the car, enterprise and connected ecosystem. Every day, you will push the boundaries of ...
-
Aichi Prefecture Pfizer Full timeWhy Patients Need You · 私たちの日々の業務はすべて、製品品質と患者さんへの安全で効果的な製品の提供に対する揺るぎないコミットメントに則したものです。私たちの科学的でリスクに基づく品質文化は、柔軟性があり、革新的で、顧客志向なものです。研究開発に関わっているかに関係なく、品質文化に対するあなたの貢献が患者さんに直接影響を与えることができます。 · Everything we do, every day, is in line with an unwavering commitment to the quality and the d ...
-
Aichi Prefecture Bristol Myers Squibb Full timeWorking with Us · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production li ...
-
Chiyoda City Bristol Myers Squibb OTHERWorking with Us · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production lin ...
-
Chiyoda City Bristol Myers Squibb OTHERWorking with Us · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production lin ...
-
F&B Coordinator
2ヶ月前
Nagoya Marriott Paid WorkJob Number · Job Category Food and Beverage & Culinary · Location Courtyard Nagoya, Sakae, Nagoya, Aichi, Japan · Schedule Full-Time · Located Remotely? N · Relocation? N · Position Type Non-Management · POSITION SUMMARY · Our jobs aren't just about putting food on the table tha ...
-
Gifu 株式会社アンビス 正社員採用情報 勤務時間 1)日勤:8:30~17:30 · 2)夜勤:16:30~翌9:30 · ※夜勤明けの次の日は基本お休み · ※日勤常勤、夜勤に制限がある場合も是非ご相談ください 想定給与 年収:491万円~533万円 · 月給:35.0万円~38.4万円 · ※夜勤5回/月手当込み · ※賞与年2回(昨年度実績3.5ヵ月分) · ※入職時年収520万円以上も可能 · ◎給与例 · 主任 537万円~ · 管理者 632万円~ 休日・休暇 年間休日115日 · 週休2日(シフト制) · 夏季休暇 2日/冬季休暇 3日 · 有給休暇:4月or10月付与 ...