Ensure on time analysis of Finished products and raw materials for required product and projects. Review of analytical data, raw data, daily usage logbooks and Lab notebooks for routine operations for analytical development function. Preparation and review of critical documents like Analytical Method validation protocol, reports, Analytical method transfer protocols and reports.
Ability to develop key partnerships internally and externally, influence and negotiate with key personnel, and plan strategically with a systems thinking approach.
End to end case management, including case receipt, database entry, peer review and submission to applicable regulatory authorities within stipulated time. Perform and monitor literature for company molecules.
Post Graduate Diploma in Clinical Trials or equivalent with at least 60% marks. At least one-year experience in clinical research. Experience in recruiting patients in clinical trials, familiarity with good documentation practices and good clinical practices.
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.
The waiting list for the said post will be approved for the next 12 months, also after the completion of the recruitment process, if the post becomes vacant due to resignation of an employee at any place in the future, appointment orders will be given to the candidates on the waiting list without conducting a fresh recruitment process.
Master, Integrated Masters in Natural or Agricultural or Pharmaceutical Sciences, Animal Sciences OR Bachelors degree in Engineering or Technology or Medicine from a recognized University