Clinical batch data review, method validation, and stability study evaluations as per cGMP & regulatory norms. Routine analysis of clinical samples and stability samples.
Confirms that site staff have completed and documented the required trainings appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times.
Maintain effective relationship with the end stakeholders medical scientific community within the allocated Global Business Unit and product – with an end objective to develop education and communication content as per requirement
Support Cross-functional team like Analytical Development, Formulation Development during product development and align documentation as per HC guidelines and Extend support for any other Regulatory related Function.
Ensure team members are trained and competent in all delivery areas. Assist the team during high work volumes by completing LTO accountabilities. Apply scientific knowledge to create compelling medical content and communications.
Biological therapies have significantly improved the quality of life for many individuals suffering from severe asthma. However, new research from Karolinska Institutet in Sweden reveals that some inflammatory immune cells may persist in the bloodstream even after treatment, raising questions about the long-term effectiveness of these drugs.
A recent study by researchers at the Technical University of Munich (TUM) has uncovered a molecular mechanism that may explain how inflammation leads to neurodegeneration in patients with multiple sclerosis
it has provided research and policy support for state and national governments and international bodies, and conventional and non-conventional technological development for society at large, including both established industries and disadvantaged groups, through innovation and adaptation.