Novo Nordisk Associate Safety Medical Writer Vacancy – Apply
Are you looking for a role as an Associate Safety Medical Writer? Join Novo Nordisk Global Business Services to have a life-changing career! Associate Safety Medical Writer. Pharma job opening 2021, Pharmacy job vacancy 2021. Check out all the details on the same below:
Job Title: Associate Safety Medical Writer
Location Bangalore, India
Job category Clinical Development and Medical
Qualifications
The below knowledge, skills, and experience will be required:
- Master’s degree in Pharmacy or equivalent medical and scientific background.
- 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 mindset, 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
Job Description:
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 the prioritization of tasks. You will provide input to investigational new drug applications (INDs), marketing authorization 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.
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