Bachelors degree in life sciences or business. Experience in consulting management in the life sciences, pharmaceutical/ biotech consulting industry or equivalent industry role
Offers leadership and basic accountability, provides strategic assistance, and planning support for clinical regulatory documents. Writers and edits clinical regulatory documents, including submission summaries and other complex documents.
Ensures that direct reports have development and training plans, according to IDP process. Coaches the direct reports on a regular basis, and plans, organizes coaching with external providers if needed.
Perform complex scientific study data review and management of CDM, Study Responsible Scientist SRS, and Study Responsible Physician related queries in EDC system. Involvement in other clinical data review activities e.g., Coding, SAE reconciliation is possible.
Review all activities promoted or induced by Bayer Mumbai CH Division that directly or indirectly involve exposure of a human being to any pharmaceutical & OTC products. Make sure that all promotional activities are made in accordance with local Regulations.
Support the development and oversight of strategic scientific publication plans and execution of operational and tactical activities within the overall medical communication platforms for assigned products, disease areas of responsibility.
Responsible for implementation of quality systems within the site. Review of Change controls, Deviations, Investigations, CAPA, OOS and OOT reports. Responsible for review of validation protocols and reports.
Day-to-day production activities, Machine operation, GMP Compliance. Exposure to Topical products like; Cream, Lotion, Gel Manufacturing and packing and its documentation. Good Communication, Presentation and Man Management skills.