Join a Legacy of Innovation 110 Years and Counting!
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Summary
This position in Compliance will provide support to Daiichi Sankyo to ensure the organization’s Compliance with relevant regulatory requirements, guidance, SOPs/SOIs consistent with applicable GXPs, Corporate Policies/AOPs/AOIs, and Compliance guidelines. At the direction of the Head of Compliance Policy, Training & Communication, this position will be responsible for: writing, developing and/or maintaining Compliance policies and procedures, developing the strategic plan for compliance training, developing and delivering Compliance training and communications, implementing Compliance program enhancements and otherwise serving as a Compliance advisor to various DSI and ARI departments, project teams, initiatives and/or committees (including but not limited to the PGC, CECC and APP Committees), as may be required. This position will be responsible for directly managing one or more Compliance professionals and overseeing assignments/workload to ensure the successful completion of department and individual objectives. This position may also collaborate and oversee projects and activities directed by the Head of Compliance Policy, Training & Communication within Compliance in order to meet Company-wide, global, and departmental objectives. Cross-functional collaboration with colleagues within Compliance and in the organization to achieve goals and objectives as well as identify and address training needs, new opportunities for Compliance guidance, and to advise on Compliance related issues is expected of this position.
Responsibilities
– Establish regular interactions with DSI and ARI business leaders to understand current risks and issues facing the business. Advise the business on Compliance related matters. In this capacity, ensure all applicable Compliance policies, procedures, training, and monitoring are functioning as planned. Ensure that interactions with business leaders of DSI on behalf of Compliance include appropriate coordination with Compliance monitoring, transparency reporting, privacy, investigation and other functions.
– Responsible for writing, developing and/or maintaining Compliance administrative policies, AOPs and AOIs applicable to the organization, or portions thereof. Serve as a Compliance advisor relative to the APP process, working with the Head of Compliance Policy, Training and Communication and Senior Members of the organization to identify gaps in current policies and procedures including the drafting, creation, updating and/or retiring of policies and procedures. This includes reviewing and interpreting new and updated laws, regulations, and industry guidance, to evaluate and make recommendations on changes to business practices and to update impacted policies, AOPs and AOIs. Collaborate with appropriate department functional leaders to create SOPs/SOIs and Corporate Policies/AOPs/AOIs.
– Develop, in consultation with Compliance Training colleagues, the Compliance training strategy and Annual Training Plan for DSI and ARI. This includes identifying potential gaps in Compliance training, serving as a subject matter expert in drafting Compliance training content, coordinating the completion of new Compliance training materials and training updates, determining resourcing/project teams for all training items included in the Annual Training Plan, and delivering Compliance training according to the Annual Plan. Review, interpret, and update training content with input from the Head of Compliance Policy, Training Communications, based upon changes in the legal and regulatory landscape, including changes to laws, industry codes, DOJ guidance, enforcement actions, etc. Responsibilities also include overseeing use of the Learning Management System to effectuate and appropriately document training.
– Based on the direction of the Head of Compliance Policy, Training Communication, oversee the implementation of Compliance program enhancement activities relative to the organization both regionally and globally. This includes continuous enhancements to the Compliance Program or supporting business processes as well as the remediation of issues identified via monitoring, auditing, the Compliance Hotline and other internal or external investigations and/or audits. At the direction of the Head of Compliance Policy, Training and Communication, handle any additional projects applicable to the implementation of an effective Compliance program as may be identified. This includes the support of global training, policy and communications initiatives as may be identified by global compliance colleagues.
– Assist in the development and implementation of the annual Compliance communication plan. Communication plan should effectively utilize various mediums including newsletter, intranet, Compliance reminder type items, memos, video, podcast, and other tools. The Communication plan fosters engagement, awareness, and education of Company employees and appropriate third parties (contractors, consultants, etc.) of the Company policies being revised, updated and/or introduced; trainings being provided (including the Annual Planning requirements); and any other initiatives undertaken by the Compliance department in support of an effective Compliance program. Draft substantive Compliance communications on all aspects of the legal and regulatory landscape, industry news and current events, and other areas of interest to the Company.
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university)
– Bachelor’s Degree from 4-year College or University of recognized standing required
– JD from Law School of recognized standing, and Bar Admission required
Experience Qualifications
– 10 or More Years experience working within a Compliance, legal or regulatory organization at a pharmaceutical company required
– experience in pharmaceutical business areas including Medical, Clinical Development (including working with GXPs within drug development or drug commercialization organizations), Sales, Marketing, and Regulatory Affairs, other related functions preferred
– Demonstrated ability and experience in managing a team of Compliance professionals preferred
Travel
Ability to travel up to 20% Global and US travel up to 20%
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
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