Medical Writer II

India

About the role

Medical Writer II

Location – Hyderabad #LI Hybrid

About the Role:
To write, review and manage the preparation of high quality clinical documents for CPO’s and global organization.

Key Responsibilities:

• To author, review and manage clinical documents: Clinical Study Reports (CSR) including narratives, Protocol, Informed Consent Form (ICF) for less complex studies independently.
• Liaise with medical/clinical experts, statisticians, investigators in concept development when protocol is being developed and work in a collaborative fashion for global/CPOs.
• Contribute to planning of data analyses and presentation to be used in CSRs.
• Ensure compliance of documentation to internal company standards and external regulatory guidelines.
• Contribute to cross-functional communication to optimize feedback and input towards high quality documents.
• Maintain audit, SOP and training compliance.
• Contributes to accurate and timely documentation of clinical trials, thereby enabling regulatory compliance of CPOs and global organization.

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.

Role Requirements

Essential Requirements
• Education Minimum university life science degree or equivalent is required. Advanced degree or equivalent education/degree in life sciences/medicine/pharmacy is desirable.
• Language: Proficiency in ‘English’ is a pre-requisite; while knowledge of other in-scope country languages would be an advantage.
• Pharmaceutical domain knowledge.
• MS-Office skills (MS-Excel, MS-Word, and MS-Power-point).
• ≥ 2 years of regulatory medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge, plus in-depth knowledge of medical writing processes.
Desirable Requirements:
• Operational knowledge of clinical trial reporting.
• Basic knowledge of biostatistics principles.

Why Novartis: 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: https://www.novartis.com/about/strategy/people-and-culture

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

Division   Operations

Business Unit  Global Business Solutions

Work Location   Hyderabad, AP

Company/Legal Entity

Nov Hltcr Shared Services Ind

Functional Area    Research & Development

Job Type   Full Time

Employment Type   Regular

Shift Work   No

Early Talent   No