Medical Writing Specialist

Category:  Clinical Development and Medical
Location: 

Søborg, Capital Region of Denmark, DK

   

Are you an experienced Medical Writer looking for possibilities to grow your career further and apply your competencies? If yes, then we would love to hear from you.

 

We are currently looking for multiple Medical Writing Specialists to join our global team. This is a fantastic opportunity to combine your scientific knowledge and writing skills in an important role within Novo Nordisk. Apply now!


About the department
You will join us in Clinical Reporting, the medical writing function at Novo Nordisk currently employing approximately 120 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 continouos 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.

The position
In this role you will work as a strategic partner in a dynamic environment to bring groundbreaking treatments to patients worldwide through planning and preparing a broad range of regulatory documents.

 

As Medical Writing Specialist, your main responsibility will be to drive the preparation of complex clinical documents and act as project manager. More specifically, you are expected to lead tasks such as:

  • Planning, development and oversight of clinical/regulatory documents, including study protocols, informed consent forms, clinical study reports (all phases), investigator’s brochures, clincial summaries, pediatric plans, briefing packages and responses to health agency questions according to business needs
  • Representing Clinical Reporting on cross-functional project teams and providing guidance on regulatory document requirements and optimal data presentation
  • Working collaboratively with other job functions across Development (notably Biostatistics, Pharmacovigilance, Medical & Science, Regulatory Affairs, Clinical Operations and others), ensuring all source information and data are appropriately reported in terms of accuracy, completeness and scientific interpretation - all in accordance with project timelines
  • Impact assessment of the new EU Clinical Trial Regulation in relevant documents

 

In addition to your own medical writing tasks, you will develop and improve our internal processes, and promote the sharing of better practices across areas. As a specialist, you will mentor and train other medical writers and be responsible for the document quality in your team, as well as your own documents.

Qualifications

  • Master’s degree within natural sciences (M.Sc., M.Sc. Pharm. or equivalent), preferably supplemented with a PhD
  • 5+ years of relevant experience in the pharmaceutical industry
  • Track-record of driving your own complex tasks from start to end and navigating many different stakeholders

 

As a person, you are an expert in communicating scientific information. You can demonstrate your ability to improve processes and to promote the sharing of better practices. You have expert understanding of clinical development, regulatory processes & requirements and clinical documents.

 

Additionally, you are a clear communicator who adapts easily to a changing environment with tight deadlines. You are strategic, proactive, and have excellent planning - and coordination skills with the competency to drive and engage teams. You effectively manage various stakeholders and are able to reach consensus. You are thorough and structured, while being pragmatic and not afraid of challenging the status quo. Furthermore, you have a positive can-do attitude and a good sense of humour.

Working at Novo Nordisk
Novo Nordisk is driving change to defeat diabetes and other serious chronic conditions. We use our skills, dedication and ambition to help change lives for the better for patients around the world. We strive for excellence, and for always keeping a positive and collaborative atmosphere in our daily work.


Contact
For further information please contact Ann Olling (+45 3079 7294), Jasper Neergaard Jacobsen (+45 3141 3449) or Mary Travers (+45-3077 6787)

 

We will review applications on an ongoing basis, so please do not hesitate to apply.
 

We are hiring for several positions with various seniority levels.


Deadline
12 Febuary 2023

 

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.