Vice President, Compliance Excellence and Transformation
Human Resources Use Only
Head of Ethics & Compliance
Compensation Use Only
Ethics & Compliance
Ethics & Compliance
Global â Chertsey, NB or Tokyo
Purpose & Scope:
The Vice President, Compliance Excellence and Transformation (CET), is a new and critical role in the Ethics & Compliance organization. This position involves transformation change within Ethics & Compliance and the business to accelerate advancement of the global ethics and compliance program. The role is accountable for independently developing strategy, enhancing, establishing, implementing and overseeing the global CET function and assisting the Head of Ethics & Compliance in advancing and overseeing a global organization dedicated to compliance and ethical behavior at local, regional and global levels. The VP Head of Ethics & Compliance, CET is accountable for critical functions and activities that support the entire organization and form the foundation of an effective and comprehensive compliance program, including global training, communications, policies/processes supporting activities which present compliance risks, compliance risk assessments, monitoring, investigations processes, a newly formed global transparency function within CET, and a newly formed global HCP/HCO interactions and external funding responsibility. This position also is a ccountable for setting and driving Ethics & Compliance support in designated areas of accountability and for making strategic independent decisions, requiring the ability to both recognize issues and develop creative solutions to drive results for the Company.
CET collaborates closely with Ethics & Compliance regional and local personnel and the business, with a focus on global operational effectiveness, efficiency and consistency consistent with the Corporate Strategic Plan. The role encompasses accountability for strategically and independently driving Ethics & Compliance globally to a culture of high performance, continual operational improvement, successful project execution and strategic partnership which integrates ethics and compliance into the business. The Head of Ethics and Compliance CET is authorized to implement all necessary actions to ensure achievement of the objectives of an effective ethics and compliance program on a global level.
Essential Job Responsibilities:
The Head of Ethics & Compliance, CET will be accountable for:
- Effective leadership of enhancing ethics and compliance culture globally, including accountability and consequences for non-compliance.
- Effectively enhancing and implementing the global compliance standard and carrying through the global standard through strategic planning and effective communication, training and monitoring of policies, controls and initiatives across functions.
- Effective idependent leadership of Ethics & Compliance in areas of designated accountability to ensure an effective compliance program and continually maturing global compliance standard by conducting business and all activities with the highest sense of ethics and integrity, with consistent and appropriate consideration of local differences.
- Independent accountability, strategic oversight, leadership and support in the designated areas of accountability to Head of Ethics & Compliance.
- Transforming the former Group Operations function within Ethics & Compliance to accelerate advancement of global Ethics & Compliance program in alignment with Corporate Strategic Plan.
- Developing strategy for and establishing a new global Transparency function within CET. This will involve transformation of the transparency function from a regional set of programs/teams to a truly centralized and globalized program and team.
- Accountable for the transformation of compliance controls/processes/systems for interactions with HCPs/HCOs and external funding into global strategic program that is integrated with business strategies and supports the Corporate Strategic Plan.
- Development of strategic annual plan and divisional performance objectives for the function and measuring progress against plan, with reporting dashboards prepared for senior management.
- Drive strategic enhancements to global risk assessment process to proactively identify and prioritize healthcare compliance risks. Working with other Heads of Ethics & Compliance to develop and implement plans to mitigate the identified risks. Developing a global risk inventory based on input from other Heads of Ethics & Compliance and relevant business stakeholders.
- Design and implementation of a scalable, flexible global monitoring strategy and program to quickly identify and respond to changing or emerging risks as well as address compliance needs before problems become systemic. Evaluating/assessing monitoring results for global trends. Collaborating with other Heads of Ethics & Compliance to determine if changes to policies/procedures, guidance or training is required.
- Designing and implementing custom enhanced assessment, monitoring and reporting programs in high risk markets.
- Developing, creating and maintaining a Data Analytics strategy (in collaboration with IT, Commercial, R&D and other business analytics teams) which supports Ethics & Compliance objectives. Aggregating data from regional and local Heads of Ethics & Compliance. Developing dashboards/reporting and prepare reports of global trends.
- Transform compliance related policies and processes into a strategic global cross-functional program. Design strategy for and drive transformation of policies and processes (e.g., simple, easy to understand, and end-to-end compliance related policies/processes). Designing and implementing global standards for policies/processes to drive consistent expectations and increased standardization of process / controls. Developing global policy and procedural templates based on global minimum standards (provide format to facilitate customization at the regional and local level).
- Developing, creating and maintaining Ethics & Compliance global training and communications strategy, training content, role-based curriculum and implementation plan / timeline with support of regional Heads of Ethics & Compliance. Training program should utilize effective adult learning methods and be aligned with the overall needs of the busines.
- Developing, creating and maintaining a communications strategy that effectively supports Tone from the Top and Tone from the Middle to continue to maintain a highly ethical and compliant culture worldwide. Developing and supporting a global Compliance Champions program. Working closely with regional Heads of Ethics & Compliance and develop supporting resources for regional and local use.
- Global reporting and investigations system and processes (e.g., maintenance of a global hotline/helpine system and process for reporting, tracking, trending, and investigating compliance concerns worldwide) to ensure that actual and potential compliance concerns are handled in a fair, timely, and comprehensive manner. Developing and maintaining a system for reporting global trends. Developing training for appropriate handling of compliance reporting, tracking, intake and investigations. Strategic and operational support to new global investigators teams.
- Partnership with E&C leaders to ensure that the Companyâs Anti-Bribery and Anti-Corruption (ABAC), Data Privacy, third party compliance risk, and distributor risk mitigation programs are integrated into the overall Ethics & Compliance program. This includes third-party due diligence processes relating to compliance and the provision of operational support to these programs, including risk assessment, monitoring, training and communication activities.
- Other Ethics & Compliance initiatives deemed necessary to further enhance Astellasâ commitment to compliance.
Responsible for operating within the global compliance budget, and any applicable project specific budgets.
- Directly reports to the Head of Ethics & Compliance
- Leads a team of at least eighteen Ethics & Compliance employees; co rresponding regional positions worldwide must coordinate with CET and implement consistent with CET strategy
- This position oversees and drives the Ethics & Compliance CET function and closely coordinates with other Heads of Ethics & Compliance for the efficient and effective implementation of CET strategy, tools and resources
- Works closely and collaborates with senior leadership of all functions across the company
The incumbent will have an excellent track record in the Legal, Regulatory or Ethics & Compliance function within the pharmaceutical industry and will bring sophisticated leadership as well as superior ethical qualities to this role.
Required qualifications include:
- Advanced degree (e.g., Juris doctor; Masters; Ph.D) or advanced compliance certifications (CCEP or equivalent).
- An established career in the pharmaceutical industry in a compliance role.
- Strong expertise in compliance with law, regulations and industry codes relevant to the pharmaceutical industry.
- Proven ability to independently and effectively lead strategic and operational transformational change across functions .
- Proven ability to idependently lead high-level, broad-based objectives in the context of annual compliance objectives and in alignment with Corporate Strategic Plan.
- Significant knowledge of the best practices relating to compliance of the pharmaceutical industry.
- Ability to work in a multi-cultural regional and global environment.
- Excellent analytical skills. Ability to interpret rules and guidelines, and ability to conceptualize and effectively drive operationalization of policies, procedures and controls.
- Demonstrates sound and independent judgment, prudence and maturity in complex and sensitive cases.
- Ability to independently prioritize and work simultaneously on multiple projects, strong attention to detail, and ability to organize and analyze complex information and data.
- Demonstrated experience leading compliance operations projects and activities in a matrixed, global organization.
- Significant leadership experience and proven success at strategically aligning with and influencing multiple senior stakeholders (e.g., Top Management) across the organization.
- Excellent written and verbal senior executive-level communication skills.
- Adaptability necessary to work effectively in a sometimes ambiguous, changing, and matrix global environment.
- Exceptional ethics and commitment to integrity, excellence, interpersonal skills, professionalism, and collegiality.
- Does not confuse effort for results.
- Tenacity to weather short-term setbacks for long-term advantages.
- Demonstrated expertise in sound and independent judgment, prudence and maturity in complex and sensitive cases.
- Client orientation with a constructive approach to resolution of issues. A style which effectively builds alliances within the organization, locally/globally, and with senior corporate collaborators
- Experience working globally and living and working in another country
- Fluency in second language(s)