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 and are committed to joy in our work.
The Senior Director Global Compliance Operations (SDGCO) is a new role on our team for a forward-thinking leader with deep cross-functional, technical, and operational expertise to drive the strategic and incremental digital transformation of our function. Specifically, the SDGCO will be responsible for the design, implementation and oversight of systems, tools & data that collectively: 1) reduce risk; 2) add operational efficiency & effectiveness; 3) increase visibility over transactional interactions; and 4) strengthen capabilities to generate actionable insights thru analytics.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
Senior Director, Global Compliance Operations
• Designing, implementing, and overseeing Emergent’s global compliance systems;
• Supporting the design and implementation of a global risk assessment program by analyzing Emergent’s compliance risk profile together with the efficacy of mitigation efforts;
• Managing risks associated with Emergent’s external interactions by establishing and maintaining processes and supporting tools to review, approve and document:
o Contractual arrangements with risk-based external stakeholders including, but not limited to government entities, healthcare professionals and healthcare-related organizations
o External funding requests such as grants, charitable donations, and sponsorships
o Objective fair market value calculations;
• Developing and launching a global compliance monitoring framework and program across the enterprise;
• Assessing, implementing, and enhancing the collection of robust, standardized data across multiple sources to enable proactive, real-time monitoring & analytics;
• Building capabilities to meet Emergent’s regulatory reporting requirements across the globe. Examples of which include:
o HCP/HCO Spend Disclosure Reporting
o Compliance Program Certifications
o Drug Price Transparency Reporting
• Designing and implementing dynamic and static reporting including as examples, dynamic dashboards utilized by business and compliance leaders, static reports on risk assessment and monitoring activities, and reporting on Emergent’s risk profile and monitoring efforts to groups such as senior management, compliance committees, and leadership teams;
• Collaborating with relevant stakeholders across the Compliance team and other risk-management functions such as Legal, Finance, and Internal Audit, to ensure an integrated approach to compliance risk assessment, auditing and monitoring, and related processes and systems;
• Drafting and implementing relevant internal compliance policies, procedures, tools, supporting resources and guidance as needed to execute risk assessment and monitoring strategies; and,
• Maintaining strong, operational 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, the OIG and DOJ guidelines, PhRMA Code, US state and local marketing compliance laws and recent government enforcement actions.
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 management’s 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
• 10-15 years of relevant experience in a compliance operations and/or monitoring role;
• Direct experience building, implementing, and overseeing global compliance systems, risk assessment and/or monitoring programs;
• Demonstrated operational knowledge of relevant laws governing the business activities of international pharmaceutical companies (anti-kick; data privacy; HCP/HCO spend transparency; price reporting), regulations and industry guidelines;
• Ability to think strategically and innovatively to find and implement solutions;
• Technologically savvy with data modeling expertise and excellent analytical and organizational skills;
• Strong communication skills, both written and verbal;
• Demonstrated ability to draft and implement company policies, procedures, and effective guidance/training materials;
• Strong organizational awareness, business acumen and ability to lead and influence without direct authority:
o Enlisting the support of various business functions as needed to achieve objectives;
o Collaboratively encouraging cooperation and teamwork across functions;
o Interacting effectively at all levels to influence business practices; and
• Demonstrates sound judgment and acts with integrity and ethics in all dealings, possesses humility, self-awareness, sense of humor, and openness to various perspectives.
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.