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EMPLOYMENT OPPORTUNITIES

 

ASSOCIATE DIRECTOR COMPLIANCE MONITORING AND RISK MANAGEMENT - Incyte Pharmaceuticals
Location: Wilmington, DE USA
Full Time
Job Requisition ID:
4484


Background:
Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.

The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.

Job Summary (Primary Function):
This position reports to the Senior Director, Compliance Monitoring, Risk, and Investigations and is responsible for leading Compliance monitoring activities, developing, and tracking corrective and preventative action plans related to compliance issues, and managing risk assessments. The position will also support other Compliance responsibilities including those related to investigations; training; communications; aggregate spend; and special projects. The role is located at Incyte's global headquarters.

Essential Functions of the Job (Key Responsibilities):

  • Development and communication of annual plans for monitoring activities based on risk assessments, results of current and prior monitoring activities, outcomes from investigations, and other sources including regulatory and enforcement updates and trends.
  • Provide assignments to internal and external monitoring resources and conduct live, transactional, and analytical monitoring ensuring fulfillment of annual commitments.
  • Develop and track corrective and preventative action plans related to confirmed compliance issues.
  • Develop and maintain dashboards and metrics that accurately report on planned versus actual monitoring status, issues, and the status of corrective and preventative action plans.
  • Conduct analysis to understand factors contributing to potential policy violations, develop recommendations and assist with the design of controls and standards for identified gaps in monitoring activities.
  • Work closely with the Compliance Business Leads to ensure that monitoring activities continuously align to identified risk areas, adhere to the approved sample selection criteria, and are executed in a consistent manner.
  • Manage the compliance monitoring system through accurate configuration and data capture, drafting business requirements, performing user acceptance testing, and assisting in the development of presentations using the system's dashboards and metrics.
  • Lead the development and execution of compliance analytics that identify trends, patterns or outliers that help drive risk-based actions and decisions.
  • Manage the Incyte Compliance Risk Assessment processes within the established timelines. This includes engaging Compliance, Legal and Business stakeholders, preparing reports of Risk Assessment results, and tracking and reporting on mitigation actions.
  • Support the Compliance Investigation process through focused transactional monitoring and other assigned research.
  • Support additional compliance initiatives and projects.

Qualifications (Minimal acceptable level of education, work experience, and competency):

  • BA/BS degree required.
  • 5-7 years of compliance, risk management or relevant bio/pharmaceutical industry experience.
  • Knowledge of compliance laws, regulations, and industry guidelines.
  • Experience independently planning and conducting complex and sensitive monitoring, including data analysis.
  • Attention to detail and focus on quality work product.
  • Ability to manage and prioritize projects under tight deadlines.
  • Excellent written, oral communication, interpersonal, and organizational skills.
  • Strong analytical, investigative, and problem-solving skills
  • Solution-oriented, team focused and strong technical skills including knowledge and experience using Microsoft applications (Excel, Word, and PowerPoint)
  • Ability to travel 25-35%.
  • Experience in compliance solutions for data analytics, monitoring and risk management preferred.

Disclaimer:
The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
We Respect Your Privacy Learn more at: www.incyte.com/privacy-policy.

The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.
During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here.

You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.

You can learn more about Incyte's data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable).

Please contact privacy@incyte.com if you have any questions or concerns or would like to exercise your rights.

 Apply here
Posted 7/2/2024

MANAGER, COMPLIANCE - Kiniksa Pharmaceuticals
Location: Lexington, MA USA


About the job
Reporting to the Associate Director, Compliance, the Manager, Compliance will serve an important role in Kiniksa's continued enhancement of its Compliance program. This position will work to assist in the implementation, maintenance, and continued improvement of Kiniksa's compliant and ethical practices and behaviors through close collaboration with internal and external business partners. The Manager, Compliance will also be primarily responsible for executing key elements of Kiniksa's auditing and monitoring program.

This role is based in our Lexington, MA office. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote.

Responsibilities (including, But Not Limited To)
Auditing & Monitoring

  • Assist in developing auditing and monitoring plans
  • Conduct in-person monitoring of Medical and Commercial activities to ensure compliance with applicable laws, regulations, and company policies
  • Conduct desk monitoring of Medical, Clinical, Commercial, and other departmental activities to ensure compliance with applicable laws, regulations, and company policies
  • Review of Medical, Commercial, and other internal documentation to ensure compliance with company SOPs and policies
  • Track and report progress of Compliance auditing and monitoring, including preparation of reports/presentations/metrics to communicate findings throughout multiple levels of the organization
  • Maintain knowledge of industry and enforcement trends and regulations to continuously inform and improve auditing and monitoring tools and templates
  • Maintain relevant auditing/monitoring systems, tools, and dashboards

Other Responsibilities

  • Work alongside employees and company leadership to maintain and further develop throughout the organization a strong culture of ethics and compliance, including personal accountability at all levels in the organization, with a spirit of partnership and positive problem solving
  • Requires the ability to be flexible and adaptable to changes. This individual must feel comfortable in creating new processes and grow with organizational and regulatory changes
  • Optimize compliance data analytics and assist in the development of data analysis tools and systems to maximize departmental efficiency
  • Maintain awareness of applicable laws and regulations and keep current with changes that may affect Kiniksa's Compliance program

Qualifications

  • 3-5+ years in compliance, audit, monitoring and/or other related experience in Biotech/Pharmaceuticals
  • B.A./B.S. degree or equivalent required (advanced degree preferred)
  • Certified Fraud Examiner (CFE), Certified Internal Auditor (CIA), Certified in Healthcare Compliance (CHC), or Project Management Professional (PMP) a plus
  • Experience developing and executing audits and monitoring activities
  • Knowledge of and experience with laws, regulations, and industry guidance that affect the pharmaceutical industry including fraud and abuse and anti-kickback statutes, OIG and PhRMA guidelines, and state marketing compliance laws
  • Experience with risk assessments and business continuity planning preferred
  • Experience managing complex projects with a strong attention to detail
  • Strong operational and project management skills required
  • Excellent organization and presentation skills. Candidate must have strong team orientation, decision making, and problem-solving skills
  • Demonstrated strong written and verbal communication skills
  • Proven mindset of proactive continuous improvement
  • Efficient independent worker with ability to focus and drive for results
  • Ability to work in a fast paced-environment and to handle multiple tasks
  • Strong commitment to compliance and ethical standards
  • Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.), as well as previous significant experience using report building software such as Tableau, Smartsheet, Cognos Report, Query Studio, or a similar software package
  • Ability to travel up to 50%

Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

 Apply here
Posted 5/30/2024

COMPLIANCE MONITORING & RISK MANAGEMENT DIRECTOR - SpringWorks Therapeutics
Location: Stamford, CT / Hybrid or USA (Remote)


About SpringWorks Therapeutics:
SpringWorks is a commercial-stage biopharmaceutical company applying a precision medicine approach to developing and delivering life-changing medicines for people with severe rare diseases and cancer.

SpringWorks has a diversified targeted oncology pipeline spanning solid tumors and hematological cancers, including clinical trials in rare tumor types and highly prevalent, genetically defined cancers. SpringWorks' strategic approach and operational excellence in clinical development have enabled it to rapidly advance its lead product candidates into late-stage trials and enter into multiple collaborations with innovators in industry and academia to unlock the full potential for its portfolio and create more solutions for patients with cancer.

SpringWorks Leadership Principles:

  • Change Steward - Recognize that change is essential; set goals that align to the Company's strategy and create positive momentum for change; adapt business practices as necessary to adjust to ever changing requirements
  • Excellence Driver - Drive high performance and ownership through an open dialog; recognize performance, empower teams and create accountability for results
  • Growth Coach - Set clear expectations, provide frequent feedback, coaching, and encourage continuous learning; leverage individual strengths to help SpringWorkers unleash their potential and grow in their jobs and careers
  • Community Builder - Establish connections with others to build strong teams that trust each other and are great at collaborating to achieve goals; create a diverse, inclusive, and psychologically safe environment

Job Summary:
SpringWorks Therapeutics is a commercial biopharmaceutical company with an approved product in the US Market and key pipeline programs in late-stage development in rare disease and oncology. The Compliance Monitoring & Risk Management Director will report directly to the company's Chief Compliance & Privacy Officer, and will lead the strategy, development, implementation, and management of the organization's Compliance and Monitoring and Risk Management program. The Director will be responsible and work independently to manage all aspect of Compliance and other related internal investigations, reporting, and analytics. The development and management of a robust monitoring and risk management program is a critical aspect of the organization's Compliance and Ethics program and overall governance and culture. The Director will lead the efforts toward continuous improvement and oversee the operations and governance of the Compliance risk management program.

Key Responsibilities:

  • Work with the Chief Compliance and Privacy Officer in setting the strategy for the organization's monitoring and risk management programs for compliance and similar risk related areas.
  • Design, implementation, and management of the company's Healthcare Compliance Monitoring Program.
  • Create, implement, and manage a broad Compliance/Ethics risk management program including conducting risk discussions, and compiling analytics and reporting.
  • Compiling and reporting on Compliance risk assessment activity and working cross-functionally with business on developing mitigation plans, where necessary.
  • Manage the cross-functional investigations process as Compliance Lead including disclosure program, investigative activity, reporting and analytics. Ensuring all compliance concerns or reports of compliance violations are investigated and resolved or properly reported.
  • Manage and enhance compliance operations mechanisms and systems to meet the needs of the company and business objectives, including without limitation, processes for debarment/exclusion screening, Sunshine Act reporting, state compliance reporting, 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.
  • Responsible for Compliance and related operations by ensuring trainings are streamlined to Integrity Works standards, identify potential gaps, and monitor for effectiveness of the training program
  • Create, modify, and implement company compliance risk management processes leveraging technology and systems.
  • Develop risk mitigation strategies and plans and related record-keeping.
  • Design control systems to address cases of violation of Compliance policies.
  • Liaise with other departmental heads for risk management and monitoring discussions
  • Perform other duties and responsibilities as assigned.

Qualifications:

  • Education: Bachelor's degree. Advanced degree in audit, law, business or substantive healthcare area, preferred.
  • 9+ years' experience in international / US healthcare compliance or similar transferrable industry experience such as audit, including material experience in developing and maintaining risk management programs, reporting, data and analytics, and investigative activities.
  • Detailed knowledge of healthcare laws and regulations, including the False Claims Act, Anti-Kickback Statute, Sunshine Act, FCPA/UKBA, and privacy laws and regulations.
  • Strong technical background in healthcare compliance-related matters arising through the commercialization and marketing of biotechnology/pharmaceutical products.
  • Able to apply knowledge and experience to address issues; able to clearly define issues.
  • Able to effect change while maintaining operating effectiveness; integrates and aligns efforts across business units and functions; monitors results and tackles problems directly.
  • Past success implementing strategic compliance risk management initiatives that align with business goals as well as budgetary realities.
  • Must possess a 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.
  • Demonstrated experience managing compliance professionals
  • 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; shapes stakeholder opinions; works through conflicts and difficult situations; negotiates for win/win solutions.
  • Cultivates internal relationships and relates well to key colleagues at all levels.
  • Embody the SpringWorks Values to act with empathy and humility to drive a culture that takes ownership and accountability for their individual and teams' performance.
  • Strong interpersonal communication skills to collaborate with colleagues, stakeholders, and vendors effectively and clearly in a remote hybrid work environment.
  • Ability to travel occasionally including overnight stay driven by business need.
  • This position must be able to work East Coast hours. #LI-Remote

Compensation:
The expected salary range for this position is $170,000 - $220,000. Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. We also offer a comprehensive benefits package for our team of SpringWorkers and their families, including competitive compensation, annual cash bonuses and equity grants, 401K matching, fully covered medical, dental, and vision plans, and a full week of holiday break at year end. It's the right thing to do - and helps us be healthy, happy, and at our best for the people who need us.

At SpringWorks, we believe in fostering a culture of belonging. Our Employee Resource Group's (ERG) mission is to boldly live the SpringWorks values, provide resources, and deeply engage SpringWorkers and the communities we serve to foster a culture of belonging. Ensuring diversity, equity, and inclusion are integral to our organization's DNA.

SpringWorks maintains an EEO Policy providing for equitable opportunities for employment and conditions of employment to all employees and applicants regardless of actual or perceived sex (including pregnancy, childbirth, breastfeeding or related medical conditions), gender, gender identity or gender expression, sexual orientation, partnership status, marital status, familial status, pregnancy status, race, color, national origin, ancestry, caste, religion, religious creed, age, alienage or citizenship status, veteran status, military status, physical or mental disability, past or present history of mental disorder, medical condition, AIDS/HIV status, sickle cellor hemoglobin C trait, genetic predisposition, genetic information, protected medical leaves, victims of domestic violence, stalking, or sex offense, political affiliation and any and all other characteristics or categories protected by applicable federal, state or local laws. SpringWorks treats all employees and applicants fairly in the selection process (and in other personnel activities) by giving all employees and applicants the same opportunities for employment. SpringWorks' Equal Employment Opportunity Policy is intended to ensure that there are no barriers that would prevent members of a protected group from a fair and equitable opportunity to be hired, promoted, or to otherwise take advantage of employment opportunities.

This Equal Employment Opportunity Policy applies to all aspects of employment, including, without limitation, recruitment, hiring, placement, job assignment, promotion, termination, transfer, leaves of absence, compensation, discipline, and access to benefits and training. Any violation of this Policy will result in disciplinary action up to and including termination of employment.

GDPR Statement:
When you apply to a job on this site, the personal data contained in your application will be collected by SpringWorks Therapeutics ("Controller"), which is located at 100 Washington Blvd, Stamford CT 6902 and can be contacted by emailing hr@springworkstx.com. Your personal data will be processed for the purposes of managing Controller's recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of Regulation (EU) 2016/679 (General Data Protection Regulation) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller's behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. Because the European Union Commission has determined that United States data privacy laws do not ensure an adequate level of protection for personal data collected from EU data subjects, the transfer will be subject to appropriate additional safeguards under the standard contractual clauses. You can obtain a copy of the standard contractual clauses by contacting us at hr@springworkstx.com.

Your personal data will be retained by Controller for as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have to right to data portability. In addition, you may lodge a complaint with an EU supervisory authority.

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Posted 5/20/2024

DEPUTY US INTEGRITY & COMPLIANCE OFFICER - Indivior
Location: Richmond, VA US (Tuesday – Thursday) and working from home Mondays and Fridays.
Reports to: US Integrity & Compliance Officer (USICO)


Indivior is a global specialty pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD) and serious mental illnesses. The name is the blend of the words individual and endeavor, and the tagline “Focus on you” makes the company's commitment clear. It represents and empathizes with the often-difficult journey each individual patient takes to overcome the challenges of addiction and mental illness.

Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of SUD. The Indivior logo radiates its patient-focused, holistic focus on expanding access to quality treatment for addiction worldwide. Building on its global portfolio of opioid use disorder treatments, Indivior has a pipeline of product candidates designed to both expand on its heritage in this category and potentially address other chronic conditions and co-occurring disorders of SUD, including alcohol use disorder and cannabis use disorder.

POSITION SUMMARY:
The Deputy US Integrity & Compliance (I&C) Officer (DUSICO) will lead the evaluation and implementation of continuous evolution within the US I&C Program, as well as serve as a strategic business partner and solutions-oriented advisor across an assigned U.S. Business Unit (BU) and Functions. The DUSICO will report to and receive guidance, support and development from the US I&C Officer (solid line reporting relationship). DUSICO will be a part of a high-performing global I&C team that ensures the effective implementation of the Indivior Global Integrity & Compliance Program (IGICP). DUSICO, together with the USICO, will play a key role in the continued growth and maturity of the US I&C program implementation against IGICP framework. DUSICO will significantly contribute to achieving the maturity strategy goals which appropriately supports a rapidly growing US business and remains in compliance with Indivior's federal DOJ, FTC and OIG agreements. They will work collaboratively across the global I&C team, and with other relevant functions and key stakeholders to achieve results. The DUSICO will also lead key Healthcare Compliance (HCC) initiatives and projects that will demonstrate and grow their leadership capabilities. Importantly, as the Deputy US I&C Officer, they will be positioned and trained to stand in for the USICO as warranted across activities, presentations and discussions in a seamless and effective manner.

The position will be located in Richmond, VA (Tuesday – Thursday) and working from home Mondays and Fridays.

ESSENTIAL FUNCTIONS:

  • Leverage robust effective Compliance program knowledge, experience, and critical thinking to evaluate key elements of the US program implementation. Following evaluation, propose and implement new ways of working spanning I&C and non-I&C owned activities. Solutions will be pragmatic, risk-based and fit-for-purpose at Indivior. The role will drive overall effectiveness, efficiency and RiskIQ, while embedding program oversight/ownership within the business and functions.
  • Provide effective, quality, and timely daily support and solutions-oriented guidance to leaders of select Functions and a BU leadership team through a cross-functional collaborative approach. BU engagement will include frequent guidance to the BU President, Marketing and Field leaders.
  • Demonstrate a high-level of emotional intelligence and a collaborative mindset. Be a strong advocate for integrity, diversity and inclusion. Promote and support a culture of high integrity through daily actions.
  • Embed and facilitate ongoing evolution of the Indivior Global Integrity & Compliance Program. This includes the execution of I&C strategic priorities across an assigned U.S. Business Unit and Functions. Appropriately guide maturity journey plans that are tailored and owned within the respective Business Unit/Functions. Leverage Indivior's Operating with Confidence Quality Decision Making Model to embed RiskIQ, ownership and quality decision making throughout support US Business Unit/Functions.
  • Guide the enhancement of control-related analytics that empower business and functional leaders to have ownership for Compliance. Direct the development of new analytics and capabilities that evolve with RiskIQ of the business and functions.
  • Effectively lead and/or serve as a key member of assigned Indivior governance committees as the I&C representative.
  • Supervise at least one Full Time Employee (FTE) and possibly additional FTEs as the US program evolves. Demonstrate effective leadership and support for the FTE(s), ensuring high-performance and demonstrated professional growth.
  • Lead the timely development, maintenance and continuous evolution of all US Healthcare Compliance (HCC)-related written standards to help support RiskIQ and knowledge retention, considerate of changes in relevant laws, regulations, Codes and guidances and results from I&C activities (e.g., audits, monitoring, investigations, assessments).
  • Engage in regular external networking (e.g., benchmarking) and professional development (e.g., certifications, external education) to maintain knowledge of regulations, codes and best practices.
  • Assume responsibilities assigned from USICO. Be prepared to effectively stand in for the USICO as warranted across activities, presentations and discussions in a seamless and effective manner, leveraging robust compliance and pharmaceutical knowledge and experience.

KEY CHALLENGES:

  • Indivior is a fast based and growing US business. It requires strategic thinking, as well as an ability to adapt and keep pace with the business, i.e., operate with compliant speed.
  • Engaging with diverse roles across the organization to demonstrate effective partnering, while embedding risk knowledge and mitigation capabilities within the business.
  • Providing timely, effective, pragmatic and sound solutions to support business needs and challenges that are risk-based and fit-for-purpose at Indivior.
  • Effective time management, organization, expectation setting and communications to manage Business Unit and Function support responsibilities and leading key strategic priorities.

MINIMUM QUALIFICATIONS:

  • Undergraduate degree required and compliance certification required
  • 8 - 10 years in the pharmaceutical industry (manufacturer preferred, but may include HCC consulting)
  • Minimum of 4 years in a senior or regional healthcare compliance role with advisory responsibilities
  • Detailed understanding of HCC impacted laws, regulations, Codes and guidances informing HCC programs
  • Experience implementing an OIG HHS CIA preferred
  • Experience implementing an annual risk assessment and activity-based needs assessments
  • Demonstrated ability to inspire company leaders to take ownership of compliance and effective root-cause evaluation and risk mitigation interventions
  • Strong project management skill set and a consistent driver of the change management process
  • Strong communications (verbal and written) and training skills (following adult learning principles)
  • Experience in leading, planning, and reporting to senior management on various healthcare compliance activities (e.g., risk management, monitoring results, strategic priorities)

COMPETENCIES/CONDUCT:

  • Recognized as a trusted advisor, committed to the success of others
  • Consistent and unwavering demonstration of Indivior guiding principles, values and culture-reaffirming behaviors and practices; embrace and demonstrate I&C Tone & Style Guide in the execution of the role to support positive and reinforcing culture of compliance and integrity
  • Effectively influences senior management to drive change and evolution
  • Flexibility in thinking and effective, timely, pragmatic problem-solving skills
  • Humble and effective leader who elevates and celebrates colleagues
  • Excellent interpersonal, communication and presentation skills
  • Strong influencing skills and ability to exercise sound, consistent judgment
  • Effectively engage in open, 2-way dialogue with internal counsel for guidance and effective risk-based, solutions-oriented approaches, elevating risk decisions as warranted by facts/circumstances
  • High standards of professional integrity and independence, maintaining essential confidentiality
  • Ability to work independently and manage a diverse and demanding workload
  • Willingness to work in a dynamic, fast-paced environment
  • Flexible to travel (minimum 30-40% of time)

BENEFITS: Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes the following benefits:

  • 3 weeks' vacation plus floating holidays and sick leave
  • 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions discount and profit sharing contribution equal to 4% of your eligible pay
  • U.S. Employee Stock Purchase Plan- 15% Discount
  • Comprehensive Medical, Dental, Vision, Life and Disability coverage
  • Health and Dependent Care Flex Spending options
  • Adoption assistance
  • Tuition reimbursement
  • Leverage Concierge/personal assistance services
  • Voluntary benefits including Legal, Pet Insurance and Auto/Home coverage
  • Gym, fitness facility and cell phone discounts
  • Our Guiding Principles, Core Values and Vision provide a culture that unites and guides our employees.

GUIDING PRINCIPLES:
Indivior's guiding principles are the foundation for each employee's success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance.

The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time.

EQUAL EMPLOYMENT OPPORTUNITY
EOE/Minorities/Females/Vet/Disabled

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Posted 5/14/2024

ETHICS & COMPLIANCE HEAD OF ANTI-BRIBERY, ANTI-CORRUPTION & THIRD-PARTY RISK MANAGEMENT - Takeda Pharmaceuticals
Location: Boston, MA US and Zurich, Switzerland
Full Time
Job Requisition ID:
R0121020


About the role:
We are seeking an experienced and strategic risk-management professional to join the Global Ethics and Compliance Team as the Global Director of Anti-Bribery and Anticorruption (ABAC). You will also be responsible for helping design, implement and continuously improve our global ABAC and TPRM programs to ensure the integrity of our business relationships and safeguard the organization against potential risks and fraud. As part of the Global Ethics & Compliance team, you will report to the Head, Ethics & Compliance Program & Governance.

How you will contribute:

1. Anti-bribery / Anti-Corruption (ABAC) Strategy:

  • Provide expertise and strategic counsel to Senior Leaders, Takeda Business Solutions and other global functions to evolve Takeda's global Anti-Bribery and Anti-Corruption (ABAC) governance program including Third Party Risk Management (TPRM).
  • Drive continuous improvement of the company-wide ABAC and TPRM programs, ensuring that Takeda complies with international legal requirements and stays ahead of societal expectations.
  • Ensure that all related ABAC and TPRM policies, standards, and practices are effectively imple-mented and followed by global business units.
  • Lead or partner on initiatives to promote a culture of integrity and ethical conduct throughout the organization.
  • Serve as the primary Compliance Business Partner to the Takeda Business Solutions Leadership Team

2. Third-Party Risk Management:

  • Serve as the most senior Ethics & Compliance expert in the design, oversight and execution of Takeda’s companywide TPRM governance program to assess, monitor and mitigate risks associated with external business partners.
  • Act as the Global E&C Representative on both the Third-Party Risk Management Steering Committee and the Global Trade Sanctions Committee
  • Serve as an escalation point to assess and resolve potential ABAC and other cases arising from third-party activities.
  • Support due diligence on potential third-party vendors, suppliers, agents, and other business as-sociates when those sue diligence are of high complexity.
  • Ensure compliance with international laws and regulations related to ABAC.
  • Enhance due diligence processes for third-party relationships, ensuring compliance with industry standards.
  • Conduct monitoring and auditing of prioritized risk areas. Partner with the business to address findings.
  • Partner and communicate regularly with senior leaders and members of the Compliance team to ensure consistency and efficiency in approach across Takeda's business units.

3. Policy Development and Compliance:

  • As SME, leads in partnership with the Policy team to design and update ABAC policies, procedures, and guidelines.
  • Ensure the organization's Compliance Program and controls are aligned with local and international anti-corruption laws and regulations.

4. Training and Awareness:

  • Oversees the Learning & Engagement team in developing and delivering training programs to educate employees and third parties on anti-corruption policies, procedures, and best practices.
  • Interacts at all levels of the organization from most senior to all employees fostering a strong awareness of bribery/corruption risks and ethical behavior within the organization.

5. Investigations and Reporting:

  • Serve as the initial point of contact and liaison to TBS for potential Investigation matters flagged by automated monitoring of third-party vendors and transactions.
  • Support investigations into allegations of corruption or unethical behavior, collaborating with internal audit, legal, and other relevant departments and oversee corrective actions with the business.
  • Prepare and present regular reports on anti-corruption and third-party risk management activities to senior management and relevant stakeholders.

6. Continuous Improvement:

  • Stay abreast of developments in ABAC laws, regulations, and industry best practices.
  • Drive continuous improvement initiatives to enhance the effectiveness of the ABAC and Third-Party Risk Management programs.
  • Ensure a fit-for-purpose auditing and monitoring of third-party business partners.

7. Collaboration and Communication:

  • Collaborate with cross-functional teams, including Legal, Compliance, Internal Audit, and Procurement, to ensure a coordinated approach to risk management.
  • Work with the LOC's and Business Units to ensure that the global ABAC and third-party risk management program is fit-for-purpose and is simple for the business to administer.
  • Serve as a global escalation point to support LOCs & BU/BFs with respect to ABAC and third-party management issues.

8. Monitoring & Analytics:

  • Champion initiatives in partnership with Monitoring, Enterprise Risk Management, Governance, and the Analytics & Insights functions.

Minimum Requirements/Qualifications:

  • Bachelor's degree in business, law, or a related field; advanced degree.
  • Experience (10+ years) in anti-corruption compliance and third-party risk management in global pharma industry
  • Experience in both leading and opertionally supporting ABAC and TPRM programs
  • In-depth knowledge of relevant ABAC laws, such as the Foreign Corrupt Practices Act (FCPA) and the UK Bribery Act
  • Analytical, investigative
  • Professional certifications relating to Compliance and ABAC
  • Demonstrated experience leading global compliance projects

More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy. #LI-Hybrid

Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

FOR LOCATION:
BOSTON, MA

U.S. Base Salary Range: $169,400.00 - $266,200.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

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Posted 4/25/2024

COMPLIANCE MANAGER - Phathom Pharmaceuticals
Location: Florham Park, NJ US


Compliance Manager
Phathom Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal (GI) diseases. We have licensed the exclusive rights in the United States, Europe, and Canada to vonoprazan, a first-in-class potassium-competitive acid blocker (PCAB). Phathom currently markets VOQUEZNA® (vonoprazan) tablets for the treatment of Erosive GERD and associated heartburn in adults, as well as VOQUEZNA® TRIPLE PAK® (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) and VOQUEZNA® DUAL PAK® (vonoprazan tablets, amoxicillin capsules) for the treatment of H. pylori infection in adults. In addition, the company is actively investigating the use of vonoprazan as a treatment for Non-Erosive GERD, with a New Drug Application currently under review by the FDA and a separate Phase 3 trial planned to initiate in 2024.

We believe we can change the status quo of treatment for acid-related disorders and have assembled a team of seasoned GI and pharmaceutical industry experts with deep expertise in developing blockbuster therapeutics, including anti-secretory agents. Our team of highly driven professionals are passionate in our mission to address unmet needs for patients and improve their quality of life. Phathom is looking for self-motivated, creative problem solvers who are excited by the idea of working in a fast-paced environment and contributing to our growth.

The Manager, Compliance will be responsible for supporting the Compliance Team and activities related to Pharmaceutical Healthcare Compliance and will report to the Director, Legal and Compliance. We are seeking candidates with strong communication skills, analytical acumen, attention to detail, and interest in being fundamental to the success of the overall organization. We welcome candidates with various background experience, with a focus on those driven to learn and excel.

Accountabilities:

  • Developing and managing relationships with stakeholders at all levels of the business and playing a lead role in embedding a good compliance culture
  • Performing routine compliance monitoring and periodic compliance audits to evaluate organizational compliance with its policies, procedures and applicable regulatory standards. Collaborates with impacted parties to develop and implement corrective action plans to address monitoring and audit findings.
  • Responsible for the execution of day-to-day Spend Transparency program activities, including but not limited to program governance and compliance, proper spend data capture practices, support for certification and submission, inquiries and dispute resolution, training, communications, monitoring, auditing and data analytics.
  • Maintain company compliance policies and procedures - work with team members to ensure they understand their roles and responsibilities defined in the specific compliance-related policies and procedures.
  • Coordinate with supporting consultants and third party vendors to drive compliance activities.
  • Oversee portfolio of required business licensed to ensure they are properly maintained and meet compliance and regulatory requirements.
  • Serve as administrator and/or liaison to multiple data repository/reporting systems including those related to transparency reporting and data analytics
  • Provide advice and support to business units on reporting and documentation requirements
  • Partner with third-party vendors to continuously improve reporting systems and practices
  • Other compliance-related tasks as assigned

Education & Experience:

  • Bachelor's degree and a minimum of 4 years experience, some of which should ideally be healthcare/compliance experience in Life Sciences field, or equivalent combination of education, training, and experience.
  • Knowledge of PhRMA Code, FDA, and OIG standards governing the sales and marketing of pharmaceuticals.
  • Knowledge and experience in producing transparency reports and working with aggregate spend data reporting systems.
  • Excellent interpersonal and communications skills.
  • Project management experience preferred.
  • Experience in drafting policies and managing compliance training programs preferred.
  • Strong track record of working in a collaborative environment with demonstrated evidence of maintaining relationships and partnerships with peers and business partners required.
  • Healthcare Compliance Certifications a plus
  • Highest level of integrity and ethics, and a commitment to maintaining the highest standards of compliance
  • Strong written and oral communication skills, including the ability to communicate complex concepts to all organizational levels, including senior management.

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Posted 4/22/2024

SR. MANAGER, COMPLIANCE - SUN PHARMA
Location: Princeton, New Jersey US (ON-SITE: Hybrid 3 days in office; 2 days remote)


Sr. Manager, Compliance
The Sr. Manager will be responsible for state price transparency reporting to state regulatory authorities, including administration of the reporting system and maintenance of all data. The individual will partner with the business to assemble and maintain accurate and complete records of pricing data and any related changes and serve as an advisor regarding potential price increases. They will also be responsible for DEA compliance monitoring and reporting in compliance with laws and regulations.

Key Responsibilities

  • Serve as administrator of multiple data repository/reporting systems including those related to state price transparency reporting and DEA monitoring
  • Provide advice and support to business units on reporting and documentation requirements
  • Maintain data consistent with regulatory authority requirements and in a readily accessible format
  • Stay up to date with changes in monitoring or reporting requirements under state price transparency reporting and State and Federal DEA laws, rules and regulations and communicate changes to impacted business units
  • Serve on cross-functional committees responsible for making pricing decisions and provide information required for compliant decision making
  • Submit all required reports in accordance with statutory requirements
  • Develop and maintain dashboards and reports
  • Partner with third-party vendors to continuously improve retention and reporting systems
  • Revise Company policies and procedures as needed
  • Develop and deliver training to applicable business unit stakeholders
  • Other compliance-related functions as assigned

Qualifications

  • BS/BA degree required
  • 3 - 5 years of compliance, audit, legal, consulting or related professional experience within the pharmaceutical industry
  • DEA compliance and/or Government Pricing preferred
  • Knowledge of the laws, regulations, guidelines and codes impacting the industry
  • Strong planning and organization skills with the ability to lead and manage multiple projects concurrently
  • Excellent organizational, analytical and communication skills with the ability to support stakeholders at all levels
  • Strong interpersonal and presentation skills and the ability to build relationships across all levels of an organization
  • Proficiency in Microsoft Office is required (e.g., Word, PowerPoint, Excel, Teams)
  • Travel between Company U.S. facilities on at least a quarterly basis to be expected. Minimal additional travel may be required

 Apply here
Posted 4/15/2024