Job Description

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 NarrativesScientific Writer IILocation xe2x80x93 Hyderabad #LI HybridAbout 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 xe2x80x93 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.

Why Novartis: Our purpose is to reimagine medicine to improve and extend peoplexe2x80x99s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-cultureYouxe2x80x99ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewardsCommitment 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.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network.Skills Desired Clinical Research, Clinical Trials, Detail-Oriented, Medical Writing, Safety

Novartis