Novartis
Location
Mumbai | India
Job description
As an Expert Regulatory Writer, you will develop documents which cover all Novartis therapeutic areas and therapies, ranging from Phase I to IV Clinical Study Reports to regulatory submission documents (e.g. Clinical Summaries, Clinical Overview, Briefing Books, answers to Health Authority Questions) for New Drug Applications (NDA), supplemental NDAs, Marketing Authorization Applications and Type II variations.
Key responsibilities: To author, review and lead high quality clinical and safety documents: Complex Clinical Study Reports (CSR), Risk Management Plans (RMP), Complex Common Technical Document (CTD) submission documents (clinical overviews, summaries of clinical efficacy and safety, summaries of clinical pharmacology and biopharmaceutics), other documents for health authorities. Lead writing team for complex submissions, actively contributing to key messaging and pooling strategy, providing expert content guidance for clinical portions of the CTD, and ensuring compliance of documentation to internal company standards and external regulatory guidelines. Ad-hoc member of Clinical Trial Team and extended member of Safety Management Team. Core member of multiple Clinical Submission Teams (CST). Extended member of Global Clinical Teams (GCT). Input into planning of data analyses and presentation (statistical analysis plan review and meetings) used in CSRs, submission documents and/or answers to questions. Documentation expert in GCTs and CSTs to ensure compliance to internal company standards and external regulatory guidelines. Program Writer for large and/or complex programs ensuring adequate medical writing resources are available for assigned program and consistency between documents. Coach and/or mentor less experienced writers & lead in cross-functional communication to optimize feedback and input towards high quality documents.Role Requirements
Minimum Life Science degree or equivalent is required. Advanced degree or equivalent education/degree in life sciences/healthcare is desirable.
6 + years medical regulatory writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge, plus experienced knowledge of medical writing processes. Expert knowledge of and repeat experience in global regulatory environment and process (key regulatory bodies, key documents, approval processes, safety reporting requirements). Excellent communication skills (written, verbal, presentations). Fluency in English is essential. Shown ability to prioritize and lead multiple demands and projects. Experience in leading global, cross-functional teams or complex global projects. Demonstrated ability to motivate and coach people.Job tags
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