Global Ethics & Compliance Director (CVRM & Medical Affairs)
Our growth story at AZ is based on our core therapeutic areas of Oncology, Respiratory, Cardiovascular/Renal/Metabolics (CVRM), Vaccines, and Immunotherapy (V&I) and investment in China, Japan, and emerging markets.
Within our Biopharmaceuticals Business Unit, our global Respiratory, CVRM, V&I, and Medical teams are at the intersection of drug development, formulation and manufacturing, commercialization, and evolving standards of medicine in primary and specialty care; developing and driving our TA strategies to bring new medicines to patients across the globe. In addition to the challenge of different local regulatory regimes, our business is constantly evolving with new innovations in digital/AI, personalized medicine, patient support programs, and real-world evidence, to name a few.
A fast-paced, innovation-driven organization also means assessing and mitigating new and changing risks. In this role you will be helping the business navigate this evolving landscape, navigating risks such as anti-bribery and inappropriate inducement, data privacy, off-label promotion, fair competition and bioethics. The ability to learn on-the-fly, adapt, and generate simple and pragmatic solutions to complex challenges is critical, as is the ability to balance business needs with informed risk management. Demonstrating a proactive ‘Business Partnering’ mindset is key to establishing the credibility and trust required to exert influence and sustain the elements of our Compliance Framework.
The Role:
Delivers strategic compliance advice and support, including partnering with the business to assess and effectively mitigate risk, educate and embed controls into business systems and processes and develop pragmatic solutions; Empowers the business as the “first line of defense” when it comes to being accountable for compliance and day-to-day risk management; Enables the business to take smart risks and be agile in a fast-paced and rapidly evolving environment
Fosters our values-based culture, starting with “We do the right thing” while we “Follow the Science,” “Put patients first,” “Play to win,” and “Be entrepreneurial.”
Builds and leverages strong relationships with leaders and management teams across different levels of the organization to drive learnings and influence decision-making; Constructively challenges the business where needed; Seen as an independent and credible advisor with a deep understanding of the business
Partners with our Oncology and Rare Disease compliance, Global Assurance, Global Compliance Investigations, and Ethics and privacy Enablement and innovation center (EPIC) teams to execute our “second line of defense” accountabilities (e.g., monitoring, internal investigations, training and awareness, risk management) to support the continuous improvement of our global compliance program.
Establishes diverse and deep networks across the business and support functions (e.g., HR, Legal, IT, Procurement, Global Business Services, Internal Audit, Media Relations) as an ambassador for our broader Ethics & Compliance strategy and champion of our Code of Ethics.
Drives global compliance objectives while supporting market and business unit priorities; facilitates information sharing and learning globally; ensures implementation of global standards at the local level, including compliance with local regulatory and trade association codes.
Supports awareness and communication activities using innovative and user-friendly resources to drive principles-based decision-making across the region; Leverages new communication channels and tools, aligning with the central Knowledge Management and Innovation team within EPIC
Drives simplification and efficiency across Units, but also across AZ; Early adopter and champion of digital ways of working
Drives implementation of centrally-driven mandatory compliance training and supports development of business-relevant case studies and tools to assist business stakeholders in the application of global policies and standards, as well as local regulatory requirements.
Supports awareness and communication activities using innovative and user-friendly resources to drive principles-based decision-making across the global BBU teams; Explores and adopts new communication channels and tools, aligning with the central Education & Engagement team priorities.
Independently interacts with leaders, management teams and across different levels of the organization to provide advice, share learnings and influence decision-making, including constructive challenge where needed.
Serves as the primary point of contact for the global BBU CVRM & GMD teams and for assurance-related activities involving the same (e.g., monitoring, investigations, incident management).
Other responsibilities as required
Requirements Education & Experience:
A BA/BSc and 8-10 years of experience in the biopharmaceutical or a related industry (e.g., medical device) and 3-5 years of experience leading area/regional/global teams is required.
An advanced degree, such as a JD or M.A./M.S. , MBA, and external experience in compliance, law, finance, audit, and/or risk management is preferred.
Deep knowledge of the health-care compliance legal framework, including EFPIA, IFPMA, GDPR, Anit-Bribery Anti-Corruption legislation; Familiarity with EU6 industry codes (e.g., UK ABPI),and the US healthcare compliance legal framework (eg. FCA, AKS, FDCA, HiPAA, SOx) and UK’s ABPI and other relevant corporate governance, health care regulations, laws and standards, including US specific healthcare fraud & abuse regulations
Demonstrated experience advising in areas of risk such as bribery & corruption, healthcare fraud, data privacy, regulations around promoting biopharmaceuticals and scientific exchange, bioethics, etc.
Demonstrated experience advising in applicable risk areas (e.g., bribery & corruption, healthcare fraud, data privacy, regulations around the promotion of bio-pharmaceuticals and scientific exchange, bioethics, etc.); experience in a compliance role strongly preferred
Established track record of people development and matrix management
Demonstrated success in continuously improving compliance frameworks across business units and/or markets; Skilled in delivering simple, business-driven solutions
Practical experience with implementing and enhancing the elements of effective compliance programs.
Skills & Abilities:
Proactive business partner mindset; Seen as a trusted and credible advisor at all levels of the business.
Solution-oriented thinker with a pragmatic approach; delivers simple solutions to complex challenges grounded in deep business acumen.
Deep understanding of compliance risks and the operation of an effective compliance program across all stages of discovery, development, medical, selling, and marketing.
Excellent interpersonal skills; Effective at building relationships and working across different geographies, cultures, time-zones, and virtual settings; Diverse work and management experience.
Strong organizational and communication skills, with a curious mindset and strong learning agility.
Uncompromising professional ethics and integrity, treats individuals with respect under all circumstances, and scrupulously protects confidential information.
Confident in exercising independent judgment and identifying when to involve other team members with relevant subject matter expertise and/or escalate matters.
Self-motivated and personally committed to self-development and growth, capable of dealing with ambiguity in a fast-paced and fluid environment.
A strong team player who prioritizes team success over personal achievement.
The annual base pay (or hourly rate of compensation) for this position ranges from $175,892.80 - $263,839.20 USD Annual.Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individualdepartment/team performance, and market factors.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.