The Pharmaceutical Compliance Forum

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EMPLOYMENT OPPORTUNITIES

 

VICE PRESIDENT, CHIEF ETHICS & COMPLIANCE OFFICER - Boehringer Ingelheim
Location: Ridgefield, CT US


Description:
The Vice President, Chief Ethics & Compliance Officer is responsible for managing the Ethics and Compliance Program for Boehringer Ingelheim USA (BI). This role directs all Ethics and Compliance activities, (including related policies and procedures, training, communication, auditing, and monitoring) for all BI operating units in the United States, across all businesses, including human pharm, animal health, and biopharmaceuticals. The incumbent directs activities of business level compliance units. This role is a member of the BI US Compliance Committee(s) and the incumbent will ensure regular reporting to the BIUSA Board and Senior Management Committees on Ethics and Compliance matters.

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Duties & Responsibilities:

  • Directs BI Ethics and Compliance Program covering BI USA and its subsidiaries, including establishing goals and priorities of business-level compliance units.
  • Directs all elements of compliance program, including developing and implementing compliance systems and tools; drafting and communicating policies; developing and implementing compliance training; developing monitoring and auditing systems (including staffing and responding to hotline inquiries); and reporting to senior management, including Board, on compliance issues.
  • Ensures that the BI USA Ethics and Compliance Program meets all applicable standards and recognized guidelines, including the Federal Sentencing Guidelines and the OIG Compliance Program Guidance for Pharmaceutical Manufacturers.
  • Manages compliance budget including oversight of compliance budgets at OPU and functional levels.
  • Directly manages staff of dedicated compliance professionals at BIUSA and directly supervises compliance officers responsible for the US businesses.
  • Ensure management and supervision including goal and priority setting; performance evaluations and compensation decisions; hiring; coordinating with General Counsel, OPU/Functional heads/presidents on the performance and expectations for local compliance groups.
  • Member of the BI USA Compliance Committee(s).
  • Routinely updates and counsels Boards, CMD, General Counsel and senior management on Ethics and Compliance issues and developments.
  • Member of the legal leadership team and the global compliance leadership network.
  • Proactive leader, including teaching and training, on ethics and compliance issues.
  • Represents the company on ethics and compliance matters to outside organizations such as the Pharmaceutical Compliance Forum, PhRMA, GPHA, and other groups and associations.
  • Liaises with compliance professionals in Global Corporate to ensure effective implementation of global compliance controls that impact US operations and legal entities.
  • Collaborates with Legal, HR and other Departments to ensure effective management of cross-Department compliance controls, including investigations, audits, communications, etc.
  • Ensures that the BI USA Ethics and Compliance Program meets all applicable standards and recognized guidelines, as appropriate for the company including considering the Federal Sentencing Guidelines and the OIG Compliance Program Guidance for Pharmaceutical Manufacturers.

Requirements:

  • Bachelor's degree with ten plus (10+) years of Ethics & Compliance or related experience; Master's degree in Business Administration or Juris Doctorate preferred.
  • More than six (6) years of leadership experience including direct management of employees.
  • Strong history of prior compliance, medical affairs, clinical, and/or legal leadership and experience in the US.
  • Understanding of international compliance requirements on US operations.
  • Substantial business, legal and regulatory knowledge, and experience in pharmaceutical industry.
  • Strong interpersonal, management and influencing skills and experience.
  • Strong leadership experience and results orientation.
  • Proven ability to lead and influence diverse groups.
  • History of successful performance.
  • Ability to Lead and influence in highly complex, matrixed international business structure.
  • Ability to influence at the most senior levels, both in the U.S. and internationally; and represents the company on ethics and compliance matters to outside organizations such as the Pharmaceutical Compliance Forum, PhRMA, GPHA, and other groups and associations.
  • Unimpeachable Integrity/Ethics.
  • Excellent judgment and ability to make difficult decisions.
  • Strong intellectual capacity and ability to learn and comprehend complex business strategies as well as legal and regulatory environments.
  • Strong backbone and ability to influence senior management.
  • Excellent communication skills. Ability to grow and develop talent.
  • Ability to act as a change agent through directing, influencing, mentoring, and modeling

Excellent leadership capabilities as displayed through:

  • Strategic identification of key stakeholders and establishment of a vision of success tied to larger organizational goals.
  • Operational management requiring a participatory approach to setting expectations and managing progress in a productive environment.
  • People leadership using emotional intelligence and successfully balancing work with recruiting, coaching, mentoring, and developing team members.
  • Constantly and proactively sharing knowledge with teams and stakeholders via formal and informal networks.
  • Enabling team members to look beyond the tactical to take account of connections to the greater whole.
  • Extracting a high level of engagement and commitment from teams by building an inclusive environment based on open and continuous dialogue.

Eligibility Requirements:

  • Must be legally authorized to work in the United States without restriction.
  • Must be willing to take a drug test and post-offer physical (if required).
  • Must be 18 years of age or older.
  • This position will require individuals to be fully vaccinated against COVID-19 or have an approved medical or religious accommodation. Click here for more information on the vaccine mandate and COVID-19.

Who We Are:
At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family-owned company, we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative, and inclusive culture. Learning and development for all employees is key because your growth is our growth.

Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health.

Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients, and communities. All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

 Apply here
Posted 9/9/2022

DIRECTOR, CORPORATE COMPLIANCE TRAINING - Oyster Point
Location: Princeton, NJ US


Summary:
The Director of Corporate Compliance Training will be responsible for the design and oversight of all corporate compliance learning and development programs and all non-GxP training within our organization. The individual will also be responsible for partnering cross-functionally to coordinate non-GxP training needs across the Company. Additional responsibilities include managing the life cycle for all corporate compliance policies and procedures; identifying training needs based on skills gap analyses; developing group and individual learning courses; operating and overseeing the non-GxP learning management system for all employees and managing the training budget. To be successful in this role, you should have solid experience with developing trainings, designing educational curriculum and drafting, implementing and overseeing the life cycle management of policies and procedures and operating learning management systems in the life sciences industry.

Primary Responsibilities:

  • Develop a role-based learning curriculum that is relevant to the business, practical in design, and demonstrates a thoughtful approach around internal and external compliance risk mitigation
  • Work as a training and competency expert with various teams and clients developing training material via eLearning, video, and other presentations.
  • Provide training to internal and external organizational clients on a broad range of topics including anti-bribery, FDA regulations, transparency reporting and company policies
  • Collaborate, coordinate, and communicate across disciplines and departments and service providers to identify, evaluate, and recommend solutions to issues identified.
  • Ensure oversight of third parties training plan for new third parties and monitor for completion; ensure refresher training are rolled out or ad hoc trainings as needed
  • Develop a scalable strategy to address training and communications needs, including partnering with internal stakeholders to align on internal standards for various audiences and enhancing the use of digital training resources
  • Actively seeks out new, cutting edge technology to further improve training and communications initiatives, and building efficiency.
  • Integrates modern and 'adult learning principles' into training program, e.g., micro-learning, risk-differentiated training, gamification/competition, the ability to mine training data for insights, and the ability to evaluate not only on-time training completion metrics, but the opportunity to demonstrate effectiveness of training, etc.
  • Periodically performs enterprise-wide gap analysis and ongoing assessment of Compliance training and communication needs.
  • Monitors mandatory training completion as well as captures and reports metrics on training completion.
  • Develops training and communication plans to document the strategy and rationale for rolling out training courses (e.g., articles, newsletters, guidance documents)
  • Ensuring procedures and policies are written, reviewed and approved per compliance requirements and regulations.

Required Skills:

  • Minimum of 7 years' experience in the life sciences industry (or in combination with another highly regulated industry) with 2-3 years of experience as a Training Director, Training Manager or similar role
  • In-depth understanding of traditional and modern training methods (including workshops, simulations, e-learning and coaching in the life sciences industry or another highly regulated industry)
  • Experience organizing training activities in a corporate environment
  • Hands-on experience with project management and budgeting
  • Proficiency in Learning Management Systems (LMS) and eLearning tools
  • Excellent communication and leadership skills
  • Experience with drafting and implementing policies and procedures in the life sciences space

Other Requirements:

  • Demonstrated experience to build strong networks with management, employees and vendors and influence to action
  • Experience in project management with the ability to manage multiple projects/assignments concurrently
  • Demonstrated planning, organization skills.
  • Detail-oriented with strong execution skills and the ability to meet multiple deadlines.

 Apply here
Posted 8/26/2022

COMPLIANCE OPERATIONS ASSOCIATE DIRECTOR - Xeris Pharmaceuticals
Reports To: Deputy Compliance and Risk Officer
Department: Compliance
Location: Chicago, IL US
Effective Date: Sept 2022


Job Purpose
Reporting to the Deputy Compliance and Risk Officer, the Compliance Operations Associate Director will lead in designing, implementing, and evaluating Xeris' Compliance Monitoring Program and the company's Federal and State Transparency Reporting program. The Compliance Operations Associate Director will help execute elements of the Company's healthcare compliance program, with an emphasis on operations of compliance business activities, HCP payment transparency reporting, and coordinating the monitoring program. In addition, the Compliance Operations Associate Director will work closely with business colleagues and shall assist with administration of the company's compliance of all applicable laws, regulations, guidance and industry standards including those of the FDA, OIG and CMS, and applicable fraud and abuse, Privacy and federal and state transparency laws.

Essential Job Functions

  • Help drive a culture of compliance throughout the organization and promote various compliance policies, procedures, and initiatives.
  • Assist with implementing and continuously improving the healthcare compliance program, including, but not limited to: developing policies, conducting training, auditing, monitoring, and conducting investigations.
  • Lead, design, and implement the Compliance Monitoring Program:
    • Creating annual plans to develop and evolve a risk-based, Monitoring Program.
    • Ensuring that risk assessment results and emerging trends are continually included into the Monitoring Plan.
    • Evaluation and deployment of appropriate systems and technologies to meet requirements of the Monitoring Program.
    • Conducting healthcare compliance monitoring, including live activities in the US (e.g., field rides, speaker programs, congresses) and documentation review (e.g., travel & expense, healthcare professional engagements)
    • Conducting healthcare compliance audits in the US (e.g., patient services, speaker's bureau) and pertaining to global functions (e.g., grants, medical information, publications)
    • Oversee the tracking of remediation for all activities
  • Lead the completion of activities related to relevant federal and state transparency-driven compliance requirements:
    • Responsible for working with the business to develop and implement tracking mechanisms and processes to facilitate capture of all HCP-related spend for federal and state reporting purposes.
    • Responsible for collection, monitoring, auditing and analyzing aggregate spend data for reporting under the Physician Payment Sunshine Act and state disclosure laws, as well as managing the remediation of data for completeness and accuracy.
    • Responsible for ensuring the accuracy and timeliness of all federal and state disclosure filings.
    • Responsible for managing third-party vendor activities around preparation, validation, and submission of federal and state transparency reports to ensure complete and timely filings.
    • Responsible for monitoring data feeds of HCP spend data from internal and external sources, communicating issues/findings to business units and vendors, and facilitating remediation.
    • Responsible for managing the process for handling physician disputes and assisting with responding to and resolving physician disputes and inquiries from covered recipients.
    • Responsible for creating and revising policy, procedures and work instructions for aggregate spend processes.
    • Responsible for providing compliance oversight of the aggregate spend system, including helping to identify new business rules, collaborating with vendor and IT partners to resolve data and operational issues, etc.
    • Responsible for collaborating with Xeris Finance department, business unit leads, and others to proactively identify and resolve aggregate spend related issues.
    • Responsible for monitoring CMS and other information sources for latest information regarding aggregate spend at both the federal and state levels.
    • Responsible for collaborating with the Xeris training team to provide transparency reporting training to applicable colleagues.
  • Maintain current understanding of laws, regulations and industry codes applicable to pharmaceutical/biotechnology business activities and compliance, along with recent trends and changes, and help provide related internal education and training.
  • Additional responsibilities as assigned.

Skills and Qualifications

  • Bachelor's degree (or equivalent work experience) required
  • Strong interest in a career in Legal and Compliance preferred
  • Required: 5-8 years of experience in a professional, fast paced environment.
  • Demonstrated knowledge and understanding of the Anti-Kickback Statute, False Claims Act, Food and Drug Administration (FDA) rules and regulations regarding the promotion of pharmaceuticals, HIPAA, Open Payments, and relevant industry guidance, specifically the PhRMA Code on Interactions with Healthcare Professionals.
  • Ability to manage multiple projects to completion on-time, meeting internal and external deliverables with high degree of accuracy.
  • Highly proficient with Adobe and Microsoft Office Suite (Excel, PowerPoint, Word, Outlook, Teams)
  • Familiarity with SharePoint or other similar systems
  • Competencies: Attention to Detail, Highly Organized, Strong Interpersonal Skills, Team Player, Self-Starter, Discrete, Excellent Verbal and Written Communication skills, Customer Service, Time Management, Project Management skills.

Skills and Qualifications

  • Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel.
  • Travel Requirements up to 5%
  • Where permitted by applicable law, must have received or be willing to receive the COVID-19 vaccine to be considered for U.S.-based job.

NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

 Apply here
Posted 8/22/2022

COMPLIANCE OPERATIONS MANAGER - SpringWorks Therapeutics
Location: Hybrid Stamford, CT US/ Remote
(Remote role - travel to offices or company meetings 1-2 x per quarter)


Overall Job Summary:
SpringWorks Therapeutics is a clinical-stage biopharmaceutical company with key pipeline programs in late-stage development, and is preparing for the expected launch of its lead investigational therapies. Reporting to the company's Compliance Officer, the Compliance Operations Manager will execute aspects of the operations of SpringWorks' global healthcare compliance & ethics program. The Compliance Operations Manager will work cross functionally supporting the Compliance, Privacy, and Legal Team operations including processes and systems.

Essential Duties and Responsibilities:

  • Support the Compliance function's operational objectives and various special projects with a goal of ensuring that SpringWorkers adhere to the highest legal and ethical standards in all business activities.
  • Help develop policies, procedures, and processes utilizing existing systems and new, innovative, tools and technology to further the company's mission and streamline operations
  • Create trainings, leveraging systems, and currently internal learning platforms.
  • Track and compile records of training using internal systems and centralized documentation. Provide regular training updates, status reports, and scorecards 'training metrics' for the Compliance, and Privacy organizations.
  • Help Support communication programs, and disclosure program awareness initiatives to enable all SpringWorkers to seek assistance, make suggestions, raise concerns or identify issues regarding compliance.
  • Support compliant interactions between field personnel, healthcare professionals (HCPs), and other customers through appropriate training and communication of policies, procedures and other requirements
  • Work at the direction of the Compliance & Privacy Leadership to ensure that all compliance concerns or reports of compliance violations as well as privacy matters are investigated and resolved or properly reported.
  • Assist in the management of compliance and legal operations mechanisms to meet the needs of the company as it prepares for commercialization, including without limitation, processes for debarment/exclusion screening, Sunshine Act reporting, state compliance reporting, privacy law compliance, FCPA/Anti-Bribery and fraud and abuse compliance, auditing / monitoring of healthcare participant-facing field roles, evaluating payments to HCPs against fair market value standards and oversight of the company's compliance hotline.
  • Assist with Legal Department operations as needed, including with various projects assigned by the Company's attorneys.
  • The position requires periodic travel for training, meetings, and field monitoring.

Other Duties and Responsibilities:

  • Project and system management
  • Vendor management from selection, onboarding, and regular engagement with vendors
  • Ability to work cross-functionally and effectively engage with a variety of roles at all levels of seniority

Education and Experience:

  • Education: Bachelor's degree.
  • Experience: 3+ years' experience in international / US healthcare compliance in the biopharmaceutical industry, including providing compliance advice or support, playing key roles in supporting compliance training to pharmaceutical/biotech companies including experience with learning management systems (LMS) and/or training technology.
  • Launch preparation and experience preferred.
  • License/Certificate: Healthcare Compliance Certification (Seton Hall) preferred

Skills:

  • Technical: Knowledge of healthcare laws and regulations, including the False Claims Act, Anti-Kickback Statute, Sunshine Act, FCPA/UKBA, and privacy laws and regulations.
  • Understanding and hands on experience with policies, procedures and process for spend capture, transparency, and Sunshine Act.
  • Leadership: Must possess a strong sense of ownership and responsibility, as well as a proven work ethic delivering excellent work product and exemplary customer service. Demonstrates passion for the business and this role; espouses a collaborative approach; leads by example in setting a positive tone for the compliance function. Ability to influence key stakeholders and drive decisions.
  • Communication: Must be able to present to and work effectively with a team. Excellent communicator in both the written and oral form; understands how to approach communication from a strategic perspective. Promotes ideas and new proposals persuasively; works through conflicts and difficult situations. Cultivates internal relationships and relates well to key colleagues at all levels.

Other:
Remote role - travel to offices or company meetings 1-2 x per quarter.

 Apply here
Posted 8/5/2022

DIRECTOR, CORPORATE COMPLIANCE - Regeneron
Location: Tarrytown, NY US


This Director, Corporate Compliance role is a strategic and dynamic role serving as a Compliance Navigator/Advisor to various areas of the business, with a particular focus on supporting the Commercial organization (marketing, sales, etc.). This individual will conduct day-to-day risk assessment and management to help support the vision for Compliance at Regeneron, by embedding ethical and risk-informed decision-making into the organization. This role is expected to be the key liaison and primary point of contact for Compliance-related topics to assigned areas of the business, including headquarters- and field-based Commercial teams. This individual will integrate practical compliance best practices within business processes. In addition, this individual will synthesize learnings from partnerships across business functions to develop innovative and agile methods to better identify Compliance risks and enhance monitoring opportunities. This individual will be expected to inspire proactive collaboration throughout Regeneron, enable business ownership of risk, and prioritize for impact.

Core expectations for this role include:

  • Agility: prioritizing risk and shifting between changing business areas, initiatives, and objectives;
  • Influencing and advocacy: leveraging substance and relationship-building to effectively navigate an organization and advance Compliance objectives; and
  • Driving solutions that are fit for purpose: developing practical Compliance initiatives by blending knowledge of Compliance standards, practical experience, and knowledge of potential perception/execution risk.

A typical day might include the following:

  • Integrate into business functions (headquarters- and field-based) to gain an in-depth understanding of current state processes and provide proactive Compliance guidance on the development and execution of proposed strategic and tactical initiatives;
  • Develop, enhance, and implement Compliance policies and procedures that are fit for Regeneron and reflective of applicable laws, regulations, government guidance, industry codes, and Regeneron policies;
  • Strategize business process improvements and change management implementation to support business and Compliance leadership in achieving operational gains;
  • Develop and implement strategic and practical risk assessment processes and management interventions that are aligned with prioritized risk areas particular to business operations and relevant monitoring activities;
  • Identify emerging Compliance key risk indicators to inform Compliance monitoring teams and analytics with practical insights from business activities;
  • Strategize innovative ways to transform internal education initiatives, through acting as a business partner between Regeneron Compliance training leads and business functions, to bridge current knowledge gaps with targeted training content;
  • Inform business leadership of Compliance knowledge gaps and larger organizational trends in a timely manner, while encouraging the open and proactive flow of information between colleagues and lines of business; and
  • Act as primary point of contact for business functions to provide regular advice and support to ensure appropriate Compliance controls are incorporated in decision-making processes and business projects.

This role may be for you if you:

  • Have the capabilities and ambition to embrace and model the "Regeneron Way" by:
    • Taking on big ideas through entrepreneurial spirt, drive, ownership, and perseverance;
    • Making it happen through flexibility, process & planning, and Compliance;
    • Being great together through teamwork & collaboration, being extraordinary, learning, communication, and care; and
    • Doing what's right through respect, inclusion, patient focus, safety & quality, and integrity & trust.
  • Have 5+ years of diversified biotech/pharmaceutical industry experience, including a minimum of 3 years of experience in US Compliance and/or relevant Legal roles;
  • Have prior project management experience;
  • Demonstrate a history of successfully resolving challenging Compliance issues
  • Have the ability to effectively deliver sound and clear Compliance advice in a business setting;
  • Have demonstrated knowledge of relevant laws, regulations, and industry practices, including the US Federal Sentencing Guidelines, the Federal Anti-Kickback Statute, the False Claims Act, the Food Drug & Cosmetic Act, the Sunshine Act, the PhRMA Code (and other applicable industry codes), HIPAA, GDPR, etc.;
  • Demonstrate confidence in developing practical Compliance solutions across business processes by blending knowledge of Compliance standards, practical experience, and knowledge of potential perception/execution risk;
  • Foster a strong internal Compliance, ethics, and speak-up culture by creating an environment in which employees see the Compliance function as a strategic partner and enabler;
  • Are able to build consensus and respectfully drive decision-making regardless of issue popularity;
  • Have willingness and desire to be a strategic leader that can drive meaningful impact aligned with Compliance organization and enterprise priorities without being dictated by a precise scope of a role;
  • Have strong problem-solving and decision-making skills, with demonstrated ability to think creatively and devise solutions to challenging problems;
  • Have the ability to gain the confidence and trust of others through demonstrating and modeling judgement, integrity, and authenticity;
  • Have strong leadership and flexible interpersonal skills to navigate various team working models, to influence without authority, to build partnerships and work collaboratively with diverse teams to meet shared objectives;
  • Have the ability to independently prioritize and work simultaneously on multiple projects, strong attention to detail, and ability to organize and analyze complex information and data;
  • Have excellent written and verbal senior executive-level communication skills.
  • To be considered for this role you must possess a J.D. from an accredited law school, or other relevant advanced degree, and be able to demonstrate a history of successfully resolving challenging Compliance/Legal issues and ability to effectively deliver sound and clear Compliance/Legal advice in a business setting.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
 Apply here
Posted 7/30/2022

SENIOR DIRECTOR COMPLIANCE BUSINESS PARTNERS - Emergent BioSolutions
Location: Gaithersburg, MD US


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.

Senior Director, Global Compliance Operations

  • 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 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

Preferred Qualifications

  • 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).

Travel
Up to 30% travel to meetings, to other sites and to perform certain compliance functions such as field monitoring. May include international travel.

 Apply here
Posted 7/25/2022

SENIOR DIRECTOR GLOBAL COMPLIANCE OPERATIONS - Emergent BioSolutions
Location: Gaithersburg, MD US


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:
    • Contractual arrangements with risk-based external stakeholders including, but not limited to government entities, healthcare professionals and healthcare-related organizations
    • External funding requests such as grants, charitable donations, and sponsorships
    • 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:
    • HCP/HCO Spend Disclosure Reporting
    • Compliance Program Certifications
    • 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:
    • Enlisting the support of various business functions as needed to achieve objectives;
    • Collaboratively encouraging cooperation and teamwork across functions;
    • 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.

 Apply here
Posted 7/22/2022

DIRECTOR, COMPLIANCE - Harmony Biosciences, LLC
Location: Plymouth Meeting, PA US


Harmony Biosciences is a pharmaceutical company headquartered in Plymouth Meeting, PA. The company was established in October 2017 with a vision to provide novel treatment options for people living with rare, neurological disorders who have unmet medical needs. For more information on Harmony Biosciences, visit www.harmonybiosciences.com.

SUMMARY:
The Exelixis Compliance Program sets policies and procedures, conducts training, and continually monitors and audits operational activities at the company in connection with a variety of laws and regulations, including but not limited to US healthcare laws governing interactions with healthcare professionals (HCP), FDA regulations, and privacy laws. The Compliance Policy and Training Manager will assist in maintaining and enhancing Exelixis' written policies, procedures and work instruction, and the various forms of training devised to educate the Exelixis workforce accordingly. More specifically, this individual will be responsible for supporting training projects and program deliverables that align to our compliance training plan and related communications. Essential business partners for this role are Commercial, Medical Affairs, Quality Assurance, Finance, Legal and HR.

DUTIES AND RESPONSIBILITIES:

  • Provide healthcare compliance advice and support to Commercial, Medical, Clinical, External Affairs and other business stakeholders in conjunction with Harmony's legal counsel.
  • Develop and implement compliance policies, SOPs, work instructions, etc., applicable to federal and state regulations, industry codes and guidance.
  • Conduct annual healthcare compliance risk assessments to prioritize and implement compliance controls.
  • Conduct live and transactional monitoring in accordance with compliance risks identified in the risk assessment.
  • Manage compliance training requirements and conduct required training classes.
  • Respond to, investigate, and remediate compliance related reports made via the ethics hotline, employees, or issues identified by Compliance.
  • Review and approve HCP fee for service arrangements.
  • Participate on review committees as applicable (e.g., External Funding Review Committees).
  • Manage Harmony's aggregate spend system and ensure the completion of federal, relevant state disclosure and transparency-driven compliance requirements.
  • Develop and implement tools which empower business stakeholders to make ethical and compliant decisions.
  • Help drive a culture of compliance throughout the organization and promote various compliance policies and procedures.
  • Maintain current understanding of laws, regulations, industry codes and guidance applicable to pharmaceutical/biotechnology business activities and Compliance, along with recent trends and changes, and help provide related internal education and training.
  • Assist the Compliance Officer with facilitating Compliance Committee meetings and act as a liaison on certain high priority cross functional projects.

SUPERVISORY RESPONSIBILITIES:

  • This position has no supervisory responsibilities.

QUALIFICATIONS:

  • Bachelors' degree, masters' degree preferred
  • 10+ years of relevant experience
  • 5+ years of experience as a healthcare compliance professional in a medical device or pharmaceutical company
  • Experience with regulators and external auditors
  • Understanding of relevant compliance laws and rules (e.g., Anti-kickback Statute, False Claims Act, etc.)
  • Strong analytical skills, with demonstrated ability to analyze compliance issues and advise accordingly
  • Demonstrated ability to manage third-party service providers
  • Excellent interpersonal skills, a commitment to professionalism, integrity and collegiality and the ability to strictly maintain confidential information.
  • Demonstrated ability to function independently with minimal guidance while simultaneously covering multi-varied project responsibilities
  • Strong verbal and written communication skills with the ability to communicate to colleagues, business partners, stakeholders and upper management across varied styles and cultures
  • Strong presentation skills and demonstrated ability to present to both small and large groups
  • Must think critically and creatively, and be able to determine appropriate resources for resolution of problems and have strong organizational and planning skills

PHYSICAL DEMANDS AND WORK ENVIORNMENT:

  • Travel is estimated to be 25% of the time for this position.
  • While performing the duties of this job, the noise level in the work environment is usually quiet.
  • Specific vision abilities required by this job include: Close vision.
  • Manual dexterity required to use computers, tablets, and cell phone.
  • Continuous sitting for prolonged periods.

**All prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19, or intend to be vaccinated for COVID-19, or qualify for a medical or sincerely held religious belief exemption to this vaccination requirement, prior to employment with Harmony Biosciences.

The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or physical requirements. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Harmony Biosciences, LLC is an Equal Opportunity, e-Verify Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.


 Apply here
Posted 7/1/2022