Experienced Safety Medical Writers

Are you on the lookout for an exceptional role giving you insights into the entire product portfolio of one of the world's leading pharmaceutical companies with R&D-driven history of innovation and best-in-class medicines?
Do you want to play a key role in ensuring patient safety by applying your expertise as a pharmacovigilance communicator? Do you build strong relationships with stakeholders and enjoy putting plans into action?
If so, then join us as a Safety Medical Writer and use your expertise to ensure patient safety and best practice.
Become a part of our unprecedented growth journey. Apply today for a life-changing career!
The position
We are seeking experienced Safety Medical Writers to lead a range of tasks of high complexity and criticality related to safety data reporting.
In this position, you will have the opportunity to:

• Be responsible for the preparation of complex aggregate safety reports, Risk Management Plans (RMPs), and responses to Health Authority questions
• Collaborate with cross-functional teams, including Clinical Development and Regulatory Affairs, to ensure high-quality scientific writing and timely reporting of safety data
• Establish close partnerships and interactions with colleagues across functions and markets, gaining extensive insights into the entire Novo Nordisk value chain
• Act as an expert for junior team members, share information, and take proactive steps to excel in your role

Our commitment to innovation also applies to the way we work. We therefore embrace the hybrid workplace - with a blend of home office in Denmark and on-site work in Søborg, Denmark where our team is based.
Qualifications
You could be our ideal candidate, if you have:

• A master's degree and/or PhD in Life Sciences (e.g., Pharmacy, Medicine, Veterinary, or Biological), combined with proven experience working within pharmacovigilance and medical writing
• Excellent analytical competencies and experience in working with large datasets
• Solid understanding of pharmacovigilance and of drug development in general
• Expert understanding of Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs) and RMPs, and the guidelines and regulations that drive their preparation
• Fluency in both written and spoken English (business language) and solid experience using MS Office

Experience in submissions of Marketing Authorisation Applications will be considered an advantage.
To succeed in this role you have passion for our purpose and an eagerness to drive change. Your ethical compass and strong sense of responsibility ensure that you have a dedicated and influential presence. You are driven to excel and inspire others to do the same.
You thrive in a multicultural environment of continuous development, and you are excellent at establishing contact, communicating, collaborating with colleagues, as well as challenging them. You have outstanding planning, and project management skills. You are analytical and able to present in a structured, clear, and accurate way.
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 Life Sciences. 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, 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 Mette Krøger Hare via email [email protected].
Deadline
29 September 2024
Please include a few sentences about why you are applying for this position in your CV. You do not need to attach a cover letter to your application.
At Novo Nordisk, we are committed to an inclusive recruitment process and equality of opportunity for all job applicants. To ensure a 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.