Clinical Submission Manager Sandoz Pvt. Ltd ..R"

Clinical Submission Manager 
Sandoz Pvt. Ltd - India

Primary contact for operational submission related activities for assigned projects Responsible for all activities related to the development and internal approval of high quality pre-clinical and clinical submission documents (e.g., summary and overview documents) in collaboration with other line functions Participate in cross-functional meetings and organize regular Clinical Submission Team Meetings Develop, negotiate and track timelines, accountabilities and responsibilities for  clinical and pre-clinical components of submission Identify issues and resource gaps for the preparation and delivery of the different documents. Ensure resolution of issues including anticipation, negotiate and implement solutions Contribute to inter- and cross-unit optimization initiatives of other clinical documents (e.g. Protocols) Contribute to continuous improvement of submission processing and knowledge transfer within BCD Desired Profile:  Advanced degree in life sciences is required At least 5 years experience in clinical research or regulatory affairs Previous successful experience in at least one submission and excellent knowledge of worldwide regulatory requirements for drug registration Demonstrated medical writing skills Fluent English (oral and written), German of advantage Excellent verbal and written communication skills. Global, cross- cultural perspective and customer orientation Great attention to accuracy and detailsclick here to view apply