This role supports the Global CECO and wider Global Ethics & Compliance team and will be
responsible for defining global policies and procedures, creating global training program
curricula and content and setting enterprise-wide compliance communication standards and
**Please note that this position can be located in either Rockville, MD or Princeton, NJ
Responsibilities include but not limited to the following:
Working with senior leadership to identify strategic priorities for updates to global policies and SOPs and assuming a lead role in creating or updating these policies/SOPs
Developing a governance approach, workflow approval, and updating process for all global compliance policies and procedures
Creating and managing a global compliance training curriculum consistent with business needs and regulatory requirements, and performing annual reviews and updates of program to optimize training standards, types, volume, access and adherence and learning outcomes
Managing and building a collaborative network of relationships with regional leaders to identify areas of risk or compliance knowledge deficiency and develop training program solutions
Creating a global communications program and implementation approach to support Ethics & Compliance initiatives, creating necessary content and managing logistics and execution
Communicating proactively with senior Ethics & Compliance leaders about issues and progress relating to global policies, training and communication initiatives
BA or BS Degree required, relevant advanced degree preferred
Proficiency in multiple languages desirable
Minimum 10 years of legal, compliance or commercial experience, preferably in the healthcare or pharmaceutical industry is required.
Strong understanding of US, EU and international pharmaceutical laws (including fraud and abuse, anti-kickback/anti-bribery, FCPA, FCA) and implications for business strategy is required.
History of successful individual contribution to writing policies, procedures, training and guidance documents required.
Deep knowledge of best-in-class training methodologies and ability to leverage technology to deliver professional learning programs required.
Experience creating and executing awareness and communications strategies and tactics required.
Ability to work and deliver on deadlines while managing multiple projects and priorities effectively
Experience working across geographies and cultures, with a variety of personalities and working styles
Strong verbal and written communications skills candidate must be skilled and comfortable with presentations to executive management
Confident in exercising independent judgment and identifying when to involve other team members with relevant subject matter expertise
Up to 20% domestic and international travel is required based upon business needs.
At Otsuka, we defy limitation, so that others can too.
We have an unwavering belief in doing more. In transcending expectations. In going above and beyondunder any circumstancesfor patients, families, providers, and for each other. Its this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day. We believe that the bigger the challenge, the bigger the opportunity. We are doing everything in our power to live up to our mission of creating new products for better health worldwide in two important therapeutic categories: neuroscience and nephrology.
Our culture is rooted in our Japanese heritage and almost 100-year history. Otsuka-people live by the core principles of Jissho the achievement, completion, and discovery of truth; and Sozosei pursuing that which only Otsuka is capable of delivering. We approach our business and overcome challenges through perseverance, unconventional thinking and humility. Learn more about Otsuka Pharmaceutical Company on its global website at http://www.otsuka.co.jp/en . Learn more about Otsuka in the U.S. at www.otsuka-us.com .
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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.