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| Job Location | Hyderabad |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Medical / Healthcare |
| Functional Area | Risk / Underwriting |
| EmploymentType | Full-time |
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 consider Novartis 799 million. That s how many lives our products touch. And while we re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people s lives We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you re given opportunities to explore the power of digital and data. Where you re empowered to risk failure by taking smart risks, and where you re surrounded by people who share your determination to tackle the world s toughest medical challenges. We are Novartis. Join us and help us reimagine medicine. Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.,
Keyskills :
risk management plansstudy reportsrisk managementmedical writingdata managementproject managersteam performancesafety managementprocess improvementequal opportunitiescommunication skillsclinical development