Hiring for Nce-cta Submission Coordinator Level 1 (On - Contract) Mumbai for Exp. 2 - 3 Years at GlaxoSmithKline Pharmaceuticals Limited.
MedWiz Delhi, New Delhi, India
Nov 10, 2018Full time
Job Description:Coordination of CTA submissions to make sure that timely delivery and making sure that the content is appropriate to each individual regulatory agency while keep-uping compliance with GSK policy and procedures Accountable to the CTA Team lead for overall work plans and to Global Regulatory Leads or Regional Representatives for definition of requirements within an agreed project. Accountability for agreed tasks and projects. Make sure that independent communication, with a range of internal GSK staff, in support achievement of the assigned goals. Make sure that compliance with GSK CTA process through timely action and completion of records in internal GSK systems Make sure that quality of own work to agreed timeframes, including compliance with GSK systems and record keeping. Experience of regulatory submissions relating to Clinical Trial Applications Sound knowledge of practical implementation of the European Clinical Trial Directive. Knowledge of clinical trial application process and review for countries outside Europe would be an advantage. Understanding of the use and importance of internal tracking to make sure that compliance with reporting and other requirements for each study protocol. Pays attention to detail is aware of the importance of accuracy and the need for compliance with submission component requirements to avoid delays through non-validation of applications. Sound interpersonal and communication skills to make sure that a reasonable level of engagement of others An ability to manage multiple tasks in parallel and organize time and actions within submission or project timeframes (weeks) Able to work effectively in, and promote, sound team working across organizational boundaries Works co-operatively in with others, individually or in teams, in order to achieve project or product goals.Takes time to reflect on own performance and learn from experience to improve overall performance and process to benefit of other projects.