Sr Director, Global Compliance Business Partner
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
I. JOB SUMMARY
Emergent is focused on continuing to evolve its strong ethics and compliance culture. The Compliance team is seeking collaborators, innovators, and problem solvers. Our team values drive us and are non-negotiable: we respect each other, have a “we” over “me” mentality, embrace diversity and inclusion, communicate transparently, and are committed to joy in our work. The Senior Director, Global Compliance is a leader on our team and is a key driver of our culture.
The Senior Director, Global Compliance is responsible for leading and supporting the continued evolution of Emergent’s Global Ethics and Compliance program with a particular focus on its expanding Commercial business. This position will have broad familiarity with the laws, regulations and industry guidelines governing the activities of U.S. headquartered pharmaceutical manufacturers with operations in global markets.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Serve as the key strategic business partner to Emergent’s Commercial business unit in the US and Internationally. Helping Commercial leaders and their teams to execute on business objectives while mitigating potential compliance-related risks inherent in the commercialization of pharmaceutical and medical counter measures products.
• Expertise and significant experience with product launches, prescription devices, vaccines and over-the-counter medicines.
• Experience supporting Market Access channel strategy and accounts, payor marketing, pricing and access strategy, payor and distributor contracting from a compliance perspective.
• Experience leading ABAC and Third-Party Due Diligence exercises and advising commercial entities re: potential risk concerns and mitigations.
• Deep knowledge of pharmaceutical industry regulations and therapeutic areas, as well as the nuances of business culture that impact business processes and compliance. Strong commercial acumen and understanding of government, market, health systems and payor dynamics.
• Support the delivery of the E&C program across the Commercial Business Unit, building key relationships with leaders and working together with the E&C Leadership team.
• Ensure Emergent has sufficient controls in place to manage company risks and align with regulatory obligations (monitoring plan, policy, procedure, training, risk assessment, etc.)
• Lead discussions with senior leaders and help shape the organizational mindset around Emergent’s Values to firmly embed ethical decision-making principles
• Resolve issues and drive alignment with Commercial senior leaders concerning E&C or Commercial-driven programs (audit remediation, policy, process)
• Collaborate with other Emergent Compliance teams (Operations and Programs) to support <function/department> operations and deliver on annual goals
• Contribute to global E&C program development (Code of Conduct, Values initiatives, Policies and Procedures, etc.)
• Increase business acumen by obtaining therapeutic and product knowledge to support marketed and pipeline products
• Lead the drafting of engaging and pragmatic policies and procedures in collaboration with key business stakeholders. Ensure policies and procedures reflect the businesses input, are accessible and clearly communicated.
• Lead the development and delivery of impactful training to enterprise stakeholders at all levels of the organization in a manner that ensures understanding and applicability of requirements as it relates to Emergent’s unique business operations.
• Provide strategic input and support the execution of the enterprise compliance risk assessment process in partnership with the business, Internal Audit and Legal. Develop annual compliance work plan based on output of risk assessment.
• Conduct monitoring and auditing of prioritized risk areas based on insights gained from compliance risk assessment. Partner with the business to address any findings.
• Provide support for compliance investigations related to potential violations of policies, laws or regulations and oversee corrective actions with the business as needed.
• Develop strategies in which the Ethics and Compliance team may utilize data gained through the various activities it undertakes (e.g. training, monitoring, investigations, etc.) to support the continuous evolution of program operations.
• Serve as a resource for emerging trends in compliance, anticipate the impact on processes, and proactively engage with business stakeholders to determine how to partner together to address them.
• Maintain a working knowledge of the various laws, regulations, and industry guidance relevant to the compliant commercialization of pharmaceutical products. This includes but is not limited to the Federal Anti-kickback Statute, False Claims Act, Food Drug and Cosmetics Act, FCPA, UK Bribery Act, the OIG and DOJ guidelines, PhRMA Code, US state and local marketing compliance laws and recent government enforcement actions. Knowledge on FTC regulations a plus.
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.
III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
Education: BA/BS degree required. J.D. is strongly desired.
Experience: 10-15 years relevant compliance experience in pharma, biotech or related environment, preferably with a globally operating company.
Knowledge: Demonstrated knowledge of relevant laws governing the business activities of international pharmaceutical companies (anti-kick; data privacy; HCP spend transparency; price reporting), regulations and industry guidelines.
Skills: Savvy with digital and tech-enhanced communications and learning platforms. Comfortable developing metrics to enable the continued evolution of the compliance program.
Abilities: Demonstrated sound judgment and acts with integrity and ethics in all dealings, possesses humility, self-awareness, sense of humor, and openness to various perspectives.
Has strong organizational awareness, business acumen and ability to:
• lead and influence without direct authority
• enlist the support of various business functions as needed to achieve objectives
• collaborate, encourage cooperation and teamwork across functions
• interact effectively at all levels to influence culture and business practices
• be creative and flexible in order to effectively communicate
• balance a strong commitment to customer service and corporate ethics
• effectively prioritizes and work in a fast-paced environment
• handle multiple complex and confidential tasks
• Knowledge of international healthcare compliance rules and regulations, European Codes of Practice related to the sales and marketing of pharmaceuticals;
• knowledgeable in other compliance risk areas (e.g. trade controls, government contracts, privacy) relevant to the pharmaceutical industry in the jurisdictions where Emergent has substantial business operations (primarily U.S., Canada, UK and EU).
Successful applicants for this position that are required to be onsite at any Emergent site at any time, must be fully vaccinated against COVID-19 as a condition of employment, subject to legally required exemptions.
There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.
Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.