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Novartis is a world leader in the research and development of products to protect and improve health and well-being. The company has core businesses in pharmaceuticals, vaccines, consumer health, generics, eye care and animal health. Headquartered in Basel, Switzerland, Novartis employs nearly 115 000 people in over 140 countries worldwide to help save lives and improve the quality of life. The Group is present in India through Novartis India Limited, listed on the Mumbai Stock Exchange and its wholly owned subsidiaries Novartis Healthcare Private Limited, Sandoz Private Limited and Chiron Behring Vaccines Private Limited.

Job ID : 215869BR

Position Title : Medical Writer-II

Division : Global Drug Development

Business Unit : GDO GDD

Country : India

Work Location : Hyderabad

Functional Area : Research & Development

Job Type : Full Time

Job Description:

To write or contribute to the preparation of high quality clinical documents for submission to regulatory authorities in support of marketing applications.

1. Write clinical study reports under supervision of more experienced writers
2.Write patient narratives autonomously.
3.Quality check patient narratives written by other writers
4.Write safety documents (e.g. RMP, DSUR) under supervision from more experienced medical writer.
5.Act as a member of clinical trial teams following protocol finalization
6.Participate in planning of analysis and data presentation to be used in study reports, initially in conjunction with mentoring medical writer.

1.Preparation of narratives, clinical study reports and (as required) other regulatory documents with respect to timelines and compliance to internal and external standards.
2.Completion of an adequate number of clinical documents (taking into account complexity) per year.
3.Adequate representation of RMW in the clinical trial team

Minimum requirements :

Minimum university life science degree or relevant equivalent background.
Excellent written and spoken English skills.
1.Basic knowledge of statistics, basic data interpretation and presentation skills.
2.Good document creation and editing skills.
3.Basic knowledge of clinical documentation.
4.Basic knowledge of drug development.

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