Associate Safety Medical Writer Life Sciences at Novo Nordisk
Associate Safety Medical Writer Life Sciences at Novo Nordisk. MSc Life Sciences Jobs. Life Sciences Associate Safety Medical Writer Vacancy. Interested and eligible applicants can check out all of the details on the same below
Name of the Post – Associate Safety Medical Writer
Location – Bangalore, India
Job category – Clinical Development and Medical
Are you looking for a role as an Associate Safety Medical Writer? Join Novo Nordisk Global Business Services to have a life-changing career!
About the department
The Global Safety department within the Global Business Services is responsible for processing ICSRs and for performing Safety Surveillance activities. Global safety has an outstanding track record in case processing and writing/publishing aggregate reports. You will join a team of highly motivated employees, responsible for the safety of the patients.
The Job
The Key responsibility for the Associate Safety Medical writer is the preparation of regulatory Safety documents and contributing to knowledge sharing, skill building and good collaboration with stakeholders and colleagues. You will become a member of the safety surveillance team which is responsible for aggregate reporting. You will especially focus on defining and integrating user/stakeholder requirements and input for the
preparation of aggregate safety reports and risk management plans. You will be given several different responsibilities and experience a variety of tasks, working with both internal and external stakeholders. The job will enhance your professional and personal development, providing you with an opportunity to develop skills within a specialist domain and project management.You will be majorly involved in planning, driving, and coordinating for the preparation of documents to ensure submission according to the submission plan, or as otherwise agreed with Regulatory affairs. You will perform medical writing tasks in Safety Surveillance including planning and preparation of Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs/PBRERs), Risk Management Plans (RMPs) and peer review of documents as backup SMW. You will also prepare responses to any safety questions raised in connection with assessment reports and contribute to the continuous resource planning process in collaboration with immediate superior – including identifying medical writing tasks and assisting in prioritisation of tasks. You will provide input to investigational new drug applications (INDs), marketing authorisation applications (MAAs), new drug applications (NDAs), variations and supplemental new drug applications (sNDAs), and investigational medicinal product dossiers (IMPDs) and other relevant ad-hoc documents.
Qualifications
The below knowledge, skills and experience will be required –
- Life Science Graduate (M.Sc. or equivalent)
- 0-2 years of experience within drug safety or clinical drug development, or basic knowledge on Pharmacovigilance
- Experience with scientific writing in English (publications or equivalent)
- Competency to use Microsoft Office (Outlook, Word, Excel and PowerPoint)
- Fluent in written and spoken English
- Analytical mind-set, systematic and detail-oriented
- Strong communicator (verbally and in writing)
- Quality mindset, well-organized and strives for excellence
- Pro-active planner to meet agreed on deliverables
- Team player with high degree of flexibility and service-focus
- Curious and looks for improvement opportunities
- Cross-cultural awareness and Professional authority
- Ability and willingness to quickly adjust to changes in a continuously developing environment.
Contact
For further information, please contact Ekta Singh at [email protected].
Deadline – 15 January 2021
Editor’s Note: Associate Safety Medical Writer Life Sciences at Novo Nordisk. Please make sure that you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of all of the latest in the industry. Follow us on all of our social media like Twitter, Telegram, Facebook and Instagram.
