Senior Regulatory Writer

313965BR
Aug 10, 2021
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 author, review and manage high quality clinical and safety documents: complex Clinical Study Reports (CSR), Development Safety Update Reports (DSUR), Risk Management Plans (RMP), submission documents (e.g., summaries of clinical efficacy and safety, summaries of clinical pharmacology and biopharmaceutics).
• Core member of Clinical Trial Team (CTT) / contributor to Safety Management Team. Major contributor to planning of data analyses and presentation used in CSRs and submission documents.
• Documentation specialist in CTTs and Clinical Submission Teams (CST) to ensure compliance of documentation to internal company standards and external regulatory guidelines. Provide content expertise and guidance for clinical portions of the CTD.
• Program Writer ensuring adequate medical writing resources are available for assigned program and consistency between documents. Extended member of International Clinical Team (ICT)
• Lead Writer for simple submissions, contributing to key messaging and pooling strategy, providing content guidance, and ensuring compliance of documentation to internal company standards and external regulatory guidelines. Core member of CST.
• Contribute to process improvement in RWS and/or cross-functional initiatives or activities. Coach and/or mentor less experienced writers.
• Leader in cross-functional communication to optimize feedback and input towards high quality documents. Maintain audit, SOP and training compliance.

Minimum Requirements

• ≥ 4 years medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge, plus in-depth knowledge of medical writing processes.
• Advanced knowledge of and experience in global regulatory environment and process (key regulatory bodies, key documents, approval processes, safety reporting requirements).
• Advanced knowledge of and repeat experience in global registration of drugs (complex submissions).
• Excellent communication skills (written, verbal, presentations). Advanced knowledge of biostatistics principles.
• Strong ability to prioritize and manage multiple demands and projects. Ability to define and solve complex problems (“Problem-solver”)
• Broad knowledge and future oriented perspective. Ability to drive and manage organizational and team performance across cultures.
• Proven track record in matrix environment. Some experience in managing global, cross-functional teams or simple global projects. Ability to motivate and coach people.

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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313965BR

Senior Regulatory Writer

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