Senior Medical Writer I Information

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Novartis Healthcare Pvt Ltd

Novartis (NYSE: NVS) is a world leader in the research and development of products to protect and improve health and well-being. The company has core businesses in pharmaceuticals, vaccines, consumer health, generics, eye care and animal health. Headquartered in Basel, Switzerland, Novartis employs nearly 115 000 people in over 140 countries worldwide to help save lives and improve the quality of life. The Group is present in India through Novartis India Limited, listed on the Mumbai Stoc... Read More

Address	Sandoz House Shivsagar Estate Dr Annie Besant Road Worli, Mumbai India
Website	www.novartis.in/
Holding	No Holding Details

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Senior Medical Writer I

To write, edit and manage the production of high quality clinical documentation for Health Authority submissions 3. Act as a member of submission teams. 4. Act as documentation consultant in clinical trial teams to ensure compliance of documentation to internal company standards and external regulatory guidelines. 5. Participate and contribute to planning of analysis and data presentation (RAP review and meetings) to be used in CSRs, summary documents and other relevant documents. 6. Can act as liaison between clinical trial teams and publishing teams and/or DRA Operations to ensure timely delivery of final documents for publishing. 7. Contribute to development of processes within OSM. Ideal Background State the minimum and desirable education & experience level Note: Information will also be used in eRecruiting job posting If eRecruiting posting is done in more than one language, include different language versions If you have a position/job profile with all details available, you can also attach/e-mail this to XDHR, but ensure that each field (e.g. Position Purpose) does not contain more than 2'100 characters due to technical limitation 2. Complete adequate number of documents as per KPIs. Minimum university life science degree or equivalent is required. Advanced degree or equivalent education/degree in life sciences/healthcare is desirable. Masters with 3-5 years of relevant experience. PhD or degree in medicine (MBBS/ MD or Alternative medicine) with 1-3 years of relevant experience. Knowledge of clinical documentation and clinical development process and regulatory requirements. Very good understanding of statistics and excellent data interpretation and presentation skills. Global, cross-cultural perspective and customer orientation. Experience of working in cross-functional teams in the drug development industry. 1.Production of high quality clinical documentation Write, review and manage independently: Narratives, CTRDs, Phase 1/ non critical CSRs. Write Phase 2, 3, and 4 CSRs, summary level documents, and RMPs. 2. Manage multiple documents simultaneously. 8. Support development of OSM through participating in OSM initiatives and other related activities. 9. Fostering cross functional communication to optimize feedback and input towards high quality documents. 10. Maintain audit, SOP and training compliance. Desired Profile Minimum university life science degree or equivalent is required.Advanced degree or equivalent education/degree in life sciences/healthcare is desirable Fluent English (oral and written) Masters with 3-5 years of relevant experience. PhD or degree in medicine (MBBS/ MD or Alternative medicine) with 1-3 years of relevant experience. Knowledge of clinical documentation and clinical development process and regulatory requirements. Very good understanding of statistics and excellent data interpretation and presentation skills. Global, cross-cultural perspective and customer orientation. Experience of working in cross-functional teams in the drug development industry. Experience 1 - 5 Years Industry Type Pharma / Biotech / Clinical Research Role Documentation/Medical Writing