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Scientific Writer II
Sandoz
posted 7hr ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
Job Description
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.
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.
: Our purpose is to reimagine medicine to improve and extend people s 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:
You ll 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-rewards
https: / / talentnetwork.novartis.com / network.
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.
: Our purpose is to reimagine medicine to improve and extend people s 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:
You ll 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-rewards
https: / / talentnetwork.novartis.com / network.
Skills Desired
Clinical Research, Clinical Trials, Detail-Oriented, Medical Writing, Safety Employment Type: Full Time, Permanent
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Flexible timing
Monday to Friday
No travel
Day Shift
Sandoz Benefits
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