Posted by on November 16, 19101 at 11:44:35:
Departmental descriptionRegional NPD IT Strategy and Consulting (rNPD IT) has been created in response to the importance of regional activities for NPD. This group will link regional and central IT activities to develop and implement coherent, regional IT strategies that form part of the NPD IT strategy.New Product Development IT (NPD IT) delivers information systems, knowledge management systems, and IT support to enable the NPD functions of Regulatory, Clinical Development, Medical Affairs, Product Strategy, Biomedical Data Sciences, Clin Pharma and Safety to be fully effective in the development, registration, reimbursement, product support, and commercialization of differentiated products of valueJob PurposeThe Japan Development & Commercialisation strategy, approved by RADEX, (R&D Executive team) contains a proposal to make a significant investment in IT capabilities in Japan. In particular, the clinical data management, clinical safety, submissions and commercial systems will be fully integrated with the centre. This will be achieved through a mixture of implementing central system in Japan and integrating local solutions with the central ones. This position is requested to ensure the solutions are delivered to agreed plans and that the central and Japan IT strategies continue to be fully integrated.
Role DescriptionKey Areas of Responsibility§ Delivery of centrally developed solutions into Japan (eg. PINNACLE, CT4, Safety and CoPilot).§ Ensuring Japanese requirements are fully understood and reflected in central plans.§ Facilitating the development of Japan IT's capabilities. This includes establishing project & quality management to the global standards.Key Accountabilities§ Develop Centre-Japan IT Strategy§ Guide Centre-Japan projects through the IT governance process§ Facilitate Centre-Japan IT infrastructure needs§ Facilitate Centre-Japan IT capability development§ Facilitate Centre-Japan IT budget activities§ Secretary of Centre-Japan IT board§ Single point of contact to manage ad hoc needs.Financial Responsibility§ Facilitate Centre-Japan IT budget activities§ Review all Japan Project Investment Proposals
The CandidateEssential Skills/Qualifications§ Fluent Japanese/English speaker§ Educated to degree level§ Knowledge of the UK and Japanese Pharma industry§ Clinical development process experience.§ Experience delivering IT solutions into Japan.§ Knowledge of clinical compliance needs.§ Knowledge of IT infrastructure (networks, desktop, middleware)§ Knowledge of financial processes and managing IT budgets greater than £2m/yearMinimum experience requirements§ 5 years as an IT professional§ 3 years US/UK – Japan IT liaison§ 3 years business analysis skills§ 3 years project management skills§ 3 year change management experience