Clinical Reporting, Head
6 months ago
The position
Lead Clinical Reporting team to set overall strategy for clinical submissions in new drug development and portfolio management in China region to fulfil regulatory requirement and business needs Guide and instruct Clinical Reporting team to generate various documents with high quality to ensure regulatory submissions and approvals in China region Ensure trial registry on time in compliance with China HA requirement Lead Clinical Reporting team to demonstrate expertise in clinical reporting within department and externally as appropriate Manage and drive performance excellence of Clinical Reporting team to achieve business goal and retain talents to maintain sustainable development of the function in China region Qualifications Master of pharmacology, medical Sciences, clinical medicine or equivalent ≥2 years of experience with scientific research methodology, including designing and conducting experiments, and analyzing and reporting experimental results ≥5 years of solid experience in clinical submission ≥5 years of experience in drug development area from pharmaceutical industries ≥3 years of experience with a broad range of various clinical submission tasks including regulatory documents and publications Working experience in international and diverse professional groups is preferred People management experience is preferred In-depth understanding of R&D value chain, including thorough understanding of regulatory processes and requirements Strategic and systematic thinking Outstanding communication and negotiation skills Proficiency in English on both written & verbal Project management skills Strong ability of making decision under complex circumstances Business orientated and drive performance excellence Coaching skills About the department In CMRQ (Clinical Medical Regulatory and Quality),We commit to bringing our products to Chinese market with the fastest speed and top quality, and applying the most scientific way to communicate our products' benefits to our customers. We have 6 team in CMRQ aiming to portfolio evaluation and overall strategy; New product approval, licence maintenance, Product localization; Clinical evidence trial operation Phase (I-IV, NIS); Multiple stakeholders’ engagement (HA/KOLs/investigators) and Medical evidence generation/communication. Working at Novo Nordisk At Novo Nordisk we recognise that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and the communities we operate in. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We are happy to discuss flexible working, depending on the role and subject to business needs. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing. Print job Send to e-mail-
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