Senior Safety Medical Writer

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Søborg

Are you looking for an opportunity to work in drug safety and use your skills as a scientific communicator? Do you build strong relationships with stakeholders and enjoy putting plans into action? If so, then join us as a Senior Safety Medical Writer and use your skills to ensure patient safety and best practice. Apply today! The position As a Senior Safety Medical Writer at Novo Nordisk A/S, you will be responsible for planning and managing and preparing aggregate safety documents (Development Safety Update Reports [DSURs], Periodic Safety Update Reports [PSURs], Clinical Risk Management Plans [RMPs]) and responses to Health Authority questions in a cross-functional environment, ensuring high quality scientific writing. You will work in close collaboration with Safety Surveillance Advisors, Medical Specialists from Global Development, Medical Advisors from Medical Affairs, and Project Managers from Regulatory Affairs. While your key responsibilities will include preparing the key safety reporting documents you will also be expected to actively contribute to process improvements and other opportunities for increasing efficiency – such as automation of administrative steps and content-based authoring. Qualifications To succeed in this role you have:
  • Documented experience working within pharmacovigilance or medical/clinical writing.

  • Background of pharmacovigilance and of drug development in general.

  • Good understanding of PSURs, DSURs and RMPs, and the guidelines and regulations that drive their preparation.

  • Higher degree in a biological/pharmaceutical science or medicine (PhD, MSc or equivalent)

  • Used to working with large datasets and have strong analytical competencies.

  • Fluency in both written and spoken English (the business language) and solid experience using MS Office

    • You thrive in a multicultural environment of continuous development, and you are good at establishing contact, communicating, collaborating with colleagues, as well as challenging them. You have strong planning, and project management skills. You are analytical and able to present in a structured, clear, and accurate way. You have high ethical standards and can prioritise your tasks and rise to challenges. About the department Safety Medical Writing is a department within Global Safety, and is situated in Søborg, Denmark and Bangalore, India. Global Safety is an organisation of more than 400 highly professional people with a high level of education within natural science. Safety Medical Writing is responsible for reporting on the emerging safety profile based on routine surveillance of all Novo Nordisk’s products (both currently marketed and under development worldwide), to ensure patient safety. Working at Novo Nordisk At Novo Nordisk, your skills, dedication, and ambition help us change lives. In exchange, we offer you an opportunity to work with talented co-workers and benefit from a range of possibilities for professional and personal development. At Novo Nordisk, we do not wait for change. We drive it. We are 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 are all working to move the needle on patient care. Contact For further information, please contact Mark White (+45) 30 79 67 10. Deadline 1 august 2023. Applications will be evaluated continuously when received and candidates may be called for an interview before the deadline. To ensure an efficient and fair recruitment process, please refrain from adding a photo to 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 7.7.2023, men kan have været deaktiveret og genaktiveret igen.

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    Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
    • Forretningsudvikler
    • Søborg
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