Expert Regulatory Writer

7 days ago

Mumbai, Maharashtra, India Novartis Full time ₹ 12,00,000 - ₹ 36,00,000 per year

Role Overview: As a Medical Writer at Novartis Healthcare Private Limited, you will be responsible for writing, reviewing, and managing the production of high-quality clinical and safety documentation for submission to regulatory authorities in support of marketing applications. Your role will also involve providing authoritative documentation-related consultancy to other line functions and coaching, mentoring, and training less experienced writers. Key Responsibilities: - Author, review, and independently manage complex Clinical Study Reports (CSR), Risk Management Plans (RMP), and other documents for health authorities. - Lead writing teams for complex submissions, contribute to key messaging and pooling strategy, and ensure compliance of documentation to internal company standards and external regulatory guidelines. - Be an ad-hoc member of Clinical Trial Team (CTT) and extended member of Safety Management Team (SMT). - Provide input into planning data analyses, ensure compliance to internal company standards and external regulatory guidelines, and lead process improvement in cross-functional initiatives. - Deliver high-quality clinical and safety documents in a timely manner and in compliance with internal and external standards. - Complete an adequate volume of work per year according to Key Performance Indicators. Qualifications Required: - At least 6 years of medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge. - Expert knowledge of the global regulatory environment. - Excellent communication skills. - Ability to prioritize and manage multiple demands and projects. - Proven experience in managing global, cross-functional teams or complex global projects. - Ability to motivate and coach people. Please note that the additional details of the company were not present in the provided job description.,

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