Senior Regulatory Content Writer
Denne stilling er desværre ikke længere ledig.
Se alle ledige stillinger
Søborg
At Novo Nordisk, we have a passion for improving patients’ lives all over the world. If you want to help us bring this passion to life, while further developing your expertise within scientific communication and act as an integral part of impactful agile teams, please apply and become the newest member of our newly established Content Management Team in Clinical Reporting. Apply now for our Senior Regulatory Content Writer job opening!
The position As a Senior Regulatory Content Writer in the Content Management Team, you will be an integral part of supporting the operational implementation of one of our newly developed digital products, NovoScribe, which has been developed to produce clinical study reports (CSRs). NovoScribe is an automated authoring platform developed using a structured authoring approach and natural language processing. It fosters a standardized, validated, and methodical approach to document creation. NovoScribe utilizes automated integration of statistical results by incorporating systematic tagging, topic-based authoring and enables reuse of standardized texts across trials. The aim of NovoScribe is to transform the way we write documents (e.g., clinical study reports) by introducing automation and natural language processing. You will be working in a transformative and innovative team, which is leading the pharmaceutical industry in automated document creation.
Your key responsibilities include: Collaborate on the development of regulatory content following established regulatory guidelines and SOPs Plan content creation and establish timelines for document production and review, aligning with overall project schedule as needed Evaluate documents for coherence, precision, scientific rigor, consistent information, and messaging, while also overseeing the document review and approval process through coordination with the study squad Responsible for maintaining the text library in the database and expanding the library to include more disease areas, in accordance with structured authoring principles Provide input to improve the database You will play a pivotal role in functional and cross-functional teams, making strategic contributions. Your active involvement in improving best practices and driving innovation in our work processes is essential. Furthermore, you will maintain an updated understanding of essential regulatory, scientific, and medical subjects that are pertinent to drug development, designated products, and specific disease/therapeutic domains.
Qualifications To be a successful candidate, you need to have a master’s degree within natural sciences (MSc., MSc. Pharm. or equivalent), preferably supplemented with a PhD and/or relevant experience in the pharmaceutical industry. You should also possess the following: The ability to produce clear, high-quality scientific writing in the English language Experience in authoring clinical study reports (CSRs) Knowledge of using and maintaining databases The ability to independently analyse and synthesize data, non-clinical and clinical concepts from a broad range of disciplines Project management skills, consistently achieves multiple tasks and goals on-time In this role, we are looking for someone with exceptional interpersonal and communication skills, both written and verbal. You should be able to work seamlessly within cross-functional teams, even when they are geographically diverse, and foster strong collaborative relationships. Your problem-solving abilities should stand out as clear and logical, and you should be comfortable adapting to changing conditions. Moreover, we value pragmatism and a willingness to challenge the status quo. You will be expected to work independently with a positive and can-do attitude. Your ability to think through problems clearly and logically, coupled with your adaptability, will make you a valuable asset to our team and help us drive forward in an ever-changing environment. About the department
You will join us in Clinical Reporting, the medical writing function at Novo Nordisk, currently comprising around 150 Medical Writers worldwide. We are part of Novo Nordisk Development and anchored in the Submission & Life Cycle Management area. Development is responsible for managing clinical drug development and submissions to health authorities worldwide, from the early development phases to market authorisation. Our supportive culture drives business transformation and we value continuous learning, being bold and striving for simplicity. Clinical Reporting covers all clinical drug development projects across therapy areas. Our main focus is to use our scientific expertise to drive clear and impactful communication on the conduct and outcome of clinical trials and our main task is to communicate clinical data in a clear and concise manner.
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 Louise Lind Skov, Head of Content Digitalisation, at +45 30755710. Deadline 21 September 2023. Note that relevant candidates may be invited for interviews on an ongoing basis before the deadline. 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.
The position As a Senior Regulatory Content Writer in the Content Management Team, you will be an integral part of supporting the operational implementation of one of our newly developed digital products, NovoScribe, which has been developed to produce clinical study reports (CSRs). NovoScribe is an automated authoring platform developed using a structured authoring approach and natural language processing. It fosters a standardized, validated, and methodical approach to document creation. NovoScribe utilizes automated integration of statistical results by incorporating systematic tagging, topic-based authoring and enables reuse of standardized texts across trials. The aim of NovoScribe is to transform the way we write documents (e.g., clinical study reports) by introducing automation and natural language processing. You will be working in a transformative and innovative team, which is leading the pharmaceutical industry in automated document creation.
Your key responsibilities include:
Qualifications To be a successful candidate, you need to have a master’s degree within natural sciences (MSc., MSc. Pharm. or equivalent), preferably supplemented with a PhD and/or relevant experience in the pharmaceutical industry. You should also possess the following:
You will join us in Clinical Reporting, the medical writing function at Novo Nordisk, currently comprising around 150 Medical Writers worldwide. We are part of Novo Nordisk Development and anchored in the Submission & Life Cycle Management area. Development is responsible for managing clinical drug development and submissions to health authorities worldwide, from the early development phases to market authorisation. Our supportive culture drives business transformation and we value continuous learning, being bold and striving for simplicity. Clinical Reporting covers all clinical drug development projects across therapy areas. Our main focus is to use our scientific expertise to drive clear and impactful communication on the conduct and outcome of clinical trials and our main task is to communicate clinical data in a clear and concise manner.
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 Louise Lind Skov, Head of Content Digitalisation, at +45 30755710. Deadline 21 September 2023. Note that relevant candidates may be invited for interviews on an ongoing basis before the deadline. 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 "Forretningsudvikler", og befinder sig i kategorien "Kommunikation, marketing, salg".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 11.9.2023, 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.
- Forretningsudvikler
- Søborg
Lignende jobs
-
Strategic Trial Planning Manager - Clinical Develo...
Are you ready to drive the successful strategic planning and management of early phase clinical trials, i.e. ClinPharm/Phase 1 studies? Does oversight and cross functional collaboration motivate yo..Få mere info- Forretningsudvikler
- Søborg
-
Senior Scientist in Late-stage Downstream Developm...
Are you ready to shape the future of API process characterization in late-stage downstream development? Do you have the expertise to drive innovative solutions and ensure seamless tech transfer in .Få mere info- Forretningsudvikler
- Bagsværd
-
Global Trial Manager
Are you passionate about clinical development? Is ensuring that clinical trials produce high-quality data and scientific documentation your top priority? If so, we want you to join our team in Card..Få mere info- Forretningsudvikler
- Søborg
-
Udviklingskonsulent til det sociale børne- og unge...
Få mere info- Forretningsudvikler
- Taastrup
Statistik over udbudte jobs som forretningsudviklere i Søborg
Herunder ser du udviklingen i udbudte forretningsudvikler i Søborg over tid. Bemærk at jobs der ikke har en bestemt geografi ikke er medtaget i tabellen. I den første kolonne ser du datoen. I den næste kolonne ser du det samlede antal forretningsudviklere.
Se flere statistikker her:
Statistik over udbudte forretningsudviklere i Søborg over tid
| Dato | Alle jobs som forretningsudviklere |
|---|---|
| 22. november 2024 | 17 |
| 21. november 2024 | 17 |
| 20. november 2024 | 15 |
| 19. november 2024 | 12 |
| 18. november 2024 | 10 |
| 17. november 2024 | 10 |
| 16. november 2024 | 10 |
| 15. november 2024 | 10 |
| 14. november 2024 | 10 |
| 13. november 2024 | 9 |
| 12. november 2024 | 8 |
| 11. november 2024 | 8 |
| 10. november 2024 | 7 |
| 9. november 2024 | 7 |
| 8. november 2024 | 6 |
| 7. november 2024 | 6 |
| 6. november 2024 | 6 |
| 5. november 2024 | 6 |
| 4. november 2024 | 7 |
| 3. november 2024 | 6 |
| 2. november 2024 | 6 |
| 1. november 2024 | 6 |
| 31. oktober 2024 | 8 |
| 30. oktober 2024 | 7 |
| 29. oktober 2024 | 6 |
| 28. oktober 2024 | 6 |
| 27. oktober 2024 | 7 |
| 26. oktober 2024 | 7 |
| 25. oktober 2024 | 8 |
| 24. oktober 2024 | 8 |
| 23. oktober 2024 | 8 |