Scientific Writer Ii

1 week ago

Hyderabad, Telangana, India Novartis Full time

Summary:

To write and/or edit under guidance high quality clinical and safety documents: non registration Clinical Study Reports (CSR), Development Safety Update Reports (DSUR), Clinical Trial Registration Documents or Patient Narratives

About the Role:

  • Scientific Writer II


 Location
  • Hyderabad #LI Hybrid
  • About the Role:
  • To write and/or edit under guidance high quality clinical and safety documents: non registration Clinical Study Reports (CSR), Development Safety Update Reports (DSUR), Clinical Trial Registration Documents or Patient Narratives

Key Responsibilities:

  • To write and/or edit under guidance high quality clinical and safety documents: non registration Clinical Study Reports (CSR), Development Safety Update Reports (DSUR), Clinical Trial Registration Documents or Patient Narratives
  • Act as documentation consultant in CTTs to ensure compliance of documentation to internal company standards and external regulatory guidelines.
  • May act as liaison between CTTs and publishing teams to ensure timely delivery of final documents for publishing.
  • Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt.
  • Distribution of marketing samples (where applicable) Timely preparation of publications to satisfy regulatory requirements for publication of clinical trial results, to increase customer awareness of company products, and to support marketing activities.

Commitment to Diversity & Inclusion:

  • We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
  • Essential Requirements:
  • Minimum: Life-science degree or equivalent B.Sc./equivalent with 4 years Clinical Research (CR) experience, M.Sc./M.Pharm + 2 years of CR experience, Desired
  • Doctoral degree, Qualification in Medical Sciences (MBBS/MD/equivalent) PhD + 1 year of CR experience, MBBS/equivalent + 1 year of CR experience

Desirable requirements:

  • Excellent written and oral English.
  • Ability to work, prioritize, and drive projects independently.
  • Ability to handle multiple projects and partners.
  • Commitment to Diversity and Inclusion:
  • Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Division
Operations

Business Unit

CTS
Location

India

Site

Hyderabad (Office)

Company / Legal Entity

IN10 (FCRS = IN010) Novartis Healthcare Private Limited

Functional Area

Research & Development

Job Type

Full time

Employment Type

Regular

Shift Work

No


Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

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