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. Headquartered in Denmark, Novo Nordisk employs approximately 33,300 employees in 75 countries, and markets its products in more than 190 countries Novo Nordisk’s B shares are listed on NASDAQ OMX Copenhagen (Novo-B).
Post: Safety Medical Writer
Job Desciption
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 safety risk management. You will be given a number of 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 specialist expertise and project management.
Medical Writing
- Plan, drive, and co-ordinate preparation of documents to ensure submission according to the submission plan, or as otherwise agreed with Regulatory affairs.
- Contribute to continuous resource planning process in collaboration with immediate superior – including identifying medical writing tasks and assist in prioritisation of tasks
- Perform consistency review of documents as back-up SMW
- Act as mentor/trainer for other safety medical writers working with the product, as required.
- 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)
- Responses to any safety questions raised in connection with assessment reports
- 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
Qualification
- Medical Doctor, Dental doctor, Master degree in pharmacy or equivalent medical and scientific background.
- Experience with scientific writing in English (publications or equivalent)
- Specific personal and job-related demands (communication skills, ability to take initiative, flexible attitude, ability to work independently/in a team, personal traits necessary in the job, etc.).
- Open and honest
- Thorough
- Analytical
- Systematic and organised
- Proactive
- Goal oriented
- Persistent
- Innovative
- Good team player
- Good at sharing knowledge
Additional Information:
Qualification: M.Pharm
Location: Bangalore
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Pharmacovigilance
Requisition ID: 31936BR
Post Date: 7 August, 2015
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