Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within Haemophilia care, growth hormone therapy and hormone replacement therapy.
Post : Associate Safety Medical Writer
Job Description
The position
The Key responsibility for Associate Safety Medical writer is preparation of regulatory Safety documents and contribute 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 co-ordinating for 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 back-up SMW. You will also prepare responses to any safety questions raised in connection with assessment reports and contribute to continuous resource planning process in collaboration with immediate superior – including identifying medical writing tasks and assist 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.
Candidate Profile
• Life Science Graduate (M.Sc. or equivalent), Medical Doctor, Dental doctor, 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 mind-set, systematic and detail-oriented
• Strong communicator (verbally and in writing)
• Quality mind-set, well-organized and strives for excellence
• Pro-active planner to meet agreed 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
Additional Information
Qualification : M.Pharm, M.Sc
Location : Bangalore, India
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Clinical Development and Medical
End Date : 15th January, 2022
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