345287BR
May 13, 2022
India

Job Description

900! That is the approximate number of individual regulatory documents the dynamic team at Regulatory Writing and Submissions (RWS) planned, developed and wrote. And that’s just in 2019! Come, join a global team of nearly 200 regulatory professionals- life scientists, clinicians and project managers across 6 countries and support Novartis in its mission to bring innovative medicines to patients worldwide. You will collaborate with colleagues from Statistics, Data Management and Clinical Development and have the opportunity to analyze data and derive key messaging to secure approvals from Health Authorities. Read on for details about the role and how you can join a world-class organization at the forefront of the industry to advance your career.

Your responsibilities include, but are not limited to:

• To write and/or edit high quality clinical and safety documents: non registration ClinicalStudy Reports (CSR), Development Safety Update Reports (DSUR), Clinical Trial Registrydocuments. Can contribute to Risk Management Plans (RMP).
• Coordinate outsourced activities in RWS.
• Participate in Clinical Trial Team (CTT).
• Participate in planning of data analyses and presentation used in CSRs.
• Documentation consultant in CTTs to ensure compliance of documentation to internalcompany standards and external regulatory guidelines.
• Act as liaison between CTTs and publishing teams to ensure timely delivery of finaldocuments for publishing.
• Support the development of RWS through participating in RWS workstreams and otherrelated activities.
• Contribute to development of processes within RWS. Maintain audit, SOP and training compliance.

Diversity & Inclusion / EEO

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

Minimum Requirements

• ≥ 1 year medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge, plus strong knowledge of the medical writing processes.
• Knowledge of global regulatory environment and process(key regulatory bodies, key documents, approval processes, safety reporting requirements).
• Excellent communication skills (written, verbal,presentations). Operational knowledge of clinical trial reporting. Knowledge of biostatistics principles.
• Ability to prioritize and manage multiple demands and projects.
• Ability to define and solve complex problems (“Problem-solver”)
• Broad knowledge and future oriented perspective. Proven track record in matrix environment
• Experience in contributing to global, cross-functional projects. Global, cross-cultural perspective and customer orientation.

WHY NOVARTIS

769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s 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
Global Drug Development
GDO GDD
India
Hyderabad, AP
Research & Development
Full Time
Regular
No
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345287BR

Senior Associate Regulatory Writer

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