The Associate Director Global R&D Clinical IT Business Information will partner with the business functions to anticipate, capture, and build business cases for the adoption of R&D systems for EDC, CTMS, Clinical Studies Data, Pharmacovigilance, Wearable, Digital, Cloud, and software development to enhance Otsukas R&D capabilities.
Leverage the platform, infrastructure, project management, application support, and corporate security functions within OIT to assess and select COTS and or software development team teams to enable R&D capabilities.
Work with stakeholders at all levels of the organization in a global, matrixed, multi-cultural, collaborative environment to evaluate cost-benefit analyses and the total cost of ownership for enabling capabilities.
Drive business and technical requirements analysis, business process modeling/mapping, methodology development, and data modeling efforts to support Otsukas clinical trials.
Minimum Bachelors degree is required. Degree in Life Sciences, Computer Science, Engineering or Business preferred. Advanced degree preferred
Minimum 7 yrs. IT experience is required
Experience in pharmaceutical R&D, Medical Affairs, and or Regulatory Affairs is preferred.
Supervisory experience in a global, matrixed, multi-cultural, collaborative environment is preferred.
Knowledge of FDA regulations, including 21 CFR Part 11, quality standards, ICH guidelines, including GCP, GLP and GAMP is required.
Strong analytical and technical skills for mapping clinical trials and or R&D needs to create plan for alignment and implementation of IT solutions is required.
Overseeing the strategy for designing, developing, and implementing software and hardware solutions, systems, or IT products within Pharmaceutical or Biotechnology R&D is required.
Ability to build strong relationships with stakeholders, work with people at all levels of the organization, and working in a global, matrixed, multi-cultural, collaborative environment.
Up to 10% domestic and international travel is required based upon business needs.
Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: Otsuka-people creating new products for better health worldwide. Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.
In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a big venture company at heart, applying creativity in everything it does.
Otsuka Pharmaceutical Company is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 50,000 people worldwide and had consolidated sales of approximately USD 11 billion ( 9.9 billion) in 2016.
All Otsuka stories start by taking the road less travelled. Learn more about Otsuka Pharmaceutical Company on its global website at www.otsuka.co.jp/en . Learn more about Otsuka in the U.S. at www.otsuka-us.com .
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.
At Otsuka, our people are passionate about developing and delivering original products as part of a global holistic commitment to better health and well-being. We have two core businesses dedicated to achieving our goals: a pharmaceutical business and a nutraceutical business. The pharmaceutical business develops and markets products for the diagnosis and treatment of disease in the following areas: central nervous system, oncology, gastroenterology, ophthalmology and cardiovascular. The nutraceutical business is dedicated to maintaining and improving health through the use of foods and beverages that provide extra health benefits in addition to their basic nutritional value. Since the beginning, nearly 100 years ago, the Otsuka family sought to develop products that stood out from the crowd, by traveling down the paths of discovery where others were less likely to tread.
We believe our culture and our people are the differentiators that empower us to produce breakthrough results. This is what makes us a big venture company that takes risks and focuses on unmet medical needs in order to develop new and better therapeutic compounds. We harness the extraordinary cr...eative and innovative abilities of our people to solve problems differently, and to persevere until they find answers. We are in this for the long-haul. Otsuka is a highly ethical company. We adhere to the highest standards in how we develop and deliver our products, and in how we treat our most valuable assets: Otsuka-people. We encourage them to follow their dreams, as turning dreams into reality is at the core of everything we do. It paves the way ahead to achieve our shared purpose: impacting on human health to help people live better lives.