Manager of Safety Medical Writing
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Bagsværd
- Clinical Development & Medical
- Bagsværd
We are looking for an energetic and self-driven manager to inspire, set direction, develop, support and manage a team of highly engaged safety medical writers. Are you the type that likes working in a fast-paced, rapidly changing, regulatory environment where tight deadlines, effective cross-functional collaboration, and focus on quality and compliance are key elements… then you may be the new manager for our team.
About the department
Safety Medical Writing is part of the Safety Surveillance organisation in Global Safety at Novo Nordisk A/S. We are a highly engaged team of 14 medical writers specialised within the field of pharmacovigilance writing situated in two sister departments in Bagsværd, Denmark, and Bangalore, India. The role of Safety Medical Writing is to prepare high quality periodic safety reports (incl. DSUR, PBRER, AOCs), global risk management plans (RMPs), and health authority responses for all Novo Nordisk products under development and marketed worldwide. Medical writers typically work in multi-disciplinary teams, interacting with all major functions across Novo Nordisk.
The position
You will be responsible for leading a team of 8-9 Safety Medical Writers in Denmark to ensure Novo Nordisk remains compliant with safety reporting requirements globally (in close collaboration with the sister department in Bangalore).
You will have a major influence on ensuring the timely preparation of high-quality scientific documents. In this role you will review and provide constructive input for key documents to ensure high quality communication and compliance with applicable regulatory guidelines and internal and industry standards. Deadlines, cross-functional collaboration and interaction with other functional areas in Novo Nordisk (especially the Clinical Development, Medical Affairs, and Regulatory Affairs), and development of your staff will be essential parts of your work day. It will be your job to set direction for your team and, whenever necessary, to participate in the implementation of new guidelines and continuous quality improvement projects.
You will report to the Director of the Safety Surveillance Reporting, and be an integral part of a management team comprising three distinct yet closely interconnected areas: Safety Medical Writing, Safety Publishing, and Business Support.
Qualifications
You have a university degree within Natural Sciences (PhD/M.Sc.). You have a minimum 5 years of experience from the pharmaceutical industry in Regulatory affairs, medical/clinical development, and/or drug safety. Solid understanding and experience with medical writing, working in a regulatory environment, drug development and data analysis is very important. Experience with pharmacovigilance will be an additional advantage.
You have high personal integrity and are responsible, well-organised, a strong communicator, able to work under pressure when needed and able to make independent decisions and prioritise.
You have excellent people skills and preferably prior experience with people/project management. Your leadership style is characterized by high empathy and the ability to coach and motivate your team to high performances. Documented experience with successful people management will be an advantage.
You are a strong driver and a dedicated team player who thrives in a global environment of continuous development, and you are good at establishing contact and collaborating with stakeholders at all levels.
You are fluent in English (both written and spoken) and are an experienced user of MS Office (Excel, PowerPoint, Word and Outlook).
Working at Novo Nordisk
At Novo Nordisk, your skills, commitment and ambition help us change lives for diabetes patients for the better. In exchange, we offer you a chance to work with extraordinary talent and to develop both professionally and personally.
Contact
For further information, please contact Mark White at +45 3079 6710.
Deadline
8 November 2019.
Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.
Information og data
Denne ledige stilling har jobtypen "Afdelingsleder", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i Bagsværd.
Jobbet er oprettet på vores service den 25.10.2019, 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.
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