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EMPLOYMENT OPPORTUNITIES

 

ASSOCIATE DIRECTOR OR DIRECTOR, COMPLIANCE COUNSEL - IONIS

Location: 2855 Gazelle Ct HQ USA, Carlsbad, CA 92010, USA
Job Category: General & Administrative - Ionis
Requisition Number: IONIS003739

Description
Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We're pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. With multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and are well positioned financially to deliver on our strategic goals.

At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know that our success is a direct result of the exceptional talents and dedication of our employees.

With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money and energy into making our onsite, hybrid and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive.

We're building on our rich history, and we believe our greatest achievements are ahead of us. If you're passionate about the opportunity to have meaningful impact on patients in need, we invite you to apply and join us. Experience and contribute to our unique culture while you develop and expand your career!

SUMMARY:
Reporting to the Director of Compliance, the Associate Director/Director/Compliance Counsel will have direct responsibility for and assist with driving, implementing, and continuously improving all elements of the Ionis US Compliance Program. This role will focus on dedicated and strategic partnership with multiple client groups, including teams within Ionis' Marketing, Patient Services, Market Access, Medical Affairs, and Commercial functions, providing advice on matters related to promotional and educational activities, engagements with healthcare providers and entities, and other applications of healthcare and regulatory compliance in the biopharmaceutical industry.

This role will also have significant interaction with Commercial functions, Medical Affairs, Regulatory Affairs, Clinical Development, IT and other functions throughout Ionis. This position requires a problem-solving mindset, a high degree of collaboration with internal clients and colleagues, and the ability to exercise mature and reliable judgment in the company's fast-paced environment.

For this position, it is preferred to be on-site in either our Carlsbad, CA or Boston, MA offices. It's open to working fully remote. For remote working, the expectation includes visits to our Carlsbad or Boston office.

RESPONSIBILITIES:

• Provides advice, guidance and counsel to commercial, medical and corporate teams on sales and marketing strategies, programs, policies, practices and initiatives with respect to compliance with relevant U.S. healthcare laws, guidance documents or opinions, and industry codes (FDCA, FDA guidance, fraud and abuse laws, anti-kickback statutes, federal and state transparency laws, OIG Advisory Opinions, PhRMA Code, etc.).
• Assists with strategic projects designed to fulfill the needs of and enhance the effectiveness of the Ionis Compliance Program and drives results-oriented process improvement.
• Assists with internal compliance investigations, ensuring legal compliance and managing risk. Assist with escalations as needed. Enforces standards and ensures appropriate follow-up action.
• Assists in remediating findings from investigations, audits, monitoring, and other assessments, keeping applicable team members apprised of relevant information
• Serves as the legal representative on cross-functional Promotional Review/Medical Review Committees to provide legal feedback and direction on advertising, promotional, and disease state awareness materials submitted for review.
• Supports medical and commercial development for assigned products, including regulatory and medical strategies, product safety, product liability analyses and risk-mitigation activities and label development.
• Reviews and provides legal guidance on financial and other interactions with healthcare professionals, patients, or others in a position to influence healthcare decisions (e.g., payers, advocacy groups, distributors, etc.) to ensure compliance with applicable laws and regulations.
• Supports execution of a robust healthcare compliance program, including creation and enforcement of company policies and procedures, risk assessments and ongoing monitoring.
• Supports Compliance leadership with change management activities. This will include educating and influencing key stakeholders about new requirements during the development of new documents and updates to existing documents to meet the changing nature of business activities. It will also include the routine maintenance of effective control documents.
• Provides legal and compliance training to Ionis personnel.
• Proactively identifies risks, opportunities and mitigating actions, and collaborates across business functions to implement.
• Partners with the Chief Compliance Officer and Compliance team to implement an effective ethics and compliance program.
• Stays informed of new laws, regulations, and industry trends affecting the company, and assists with the development of policies and training as needed

REQUIREMENTS:

• Strong sense of integrity, understanding of business transaction transparency, and the ability to balance business interests with the need to exercise independent judgment.
• Proven capacity to cultivate strong client relationships and successfully influence leadership in a dynamic, innovative business climate.
• Juris Doctorate or equivalent law degree required.
• Admission to a State Bar
• For the Associate Director position, a minimum of 8 years of professional work experience at a law firm or in-house legal department and/or a minimum of 8 years supporting the pharmaceutical or biotech industry as in-house counsel (pharma/biotech preferred) or in a law firm, including experience in regulatory law and commercial-related matters.
• For the Director position, a minimum 12 years of professional work experience at a law firm or in-house legal department and/or a minimum of 12 years supporting the pharmaceutical or biotech industry as in-house counsel (pharma/biotech preferred) or in a law firm, including experience in regulatory law and commercial-related matters.
• A thorough understanding of regulatory and legal frameworks governing the sales and marketing of approved medicines, and regulatory framework for investigational medicines.
• Demonstrated ability to grasp statutory and regulatory concepts quickly, proactively identify and analyze potential legal issues and provide thoughtful and creative business-focused legal advice and solutions.
• Experience conducting legal review of materials submitted for Medical/Regulatory/Legal (MLR) Review.
• Knowledge of laws, regulations, and industry guidance that affect the pharmaceutical industry, including FDCA, FDA guidance, fraud and abuse, and anti-kickback statutes, OIG and PhRMA guidelines, and state marketing compliance laws.
• Knowledge and experience with managed markets, payer and PBM contracting, patient support programs and/or government pricing a plus.
• Ability to work independently and in a fast-paced environment and handle multiple complex and confidential tasks.
• Ability to analyze and interpret technical procedures, government regulations, and legal documents.
• Excellent communication and interpersonal skills.
• Exceptional attention to detail and deadlines.

 Apply here
Posted 5/30/2025

SENIOR MANAGER COMPLIANCE PROGRAMS - Lundbeck Pharmaceuticals
Location: Deerfield, IL US

SUMMARY:
This role will report directly to the Director, Compliance Programs and have direct responsibility for and assist with driving and implementing all elements of the Lundbeck US Compliance Program, which are modeled after the seven elements of an effective compliance program. This role will focus on dedicated, strategic partnership with the home office and work closely with key stakeholders and partner with all lines of business (LOB) in support of organizational Compliance and overall business. Specifically, this role will be responsible for developing, implementing, and executing the Compliance training and communications program, as well as developing and updating healthcare policies, procedures and controls.

ESSENTIAL FUNCTIONS:

• Business Partnership: Serve as a business partner to designated business units across Lundbeck. Proactively provide guidance and support to all stakeholders across the organization on compliance matters. Develop trusted partnerships and effective lines of communication across the company. Participate in cross-functional initiatives and help drive a compliant culture.
• Policies, Procedures and Controls, including Code of Conduct: In partnership with the Director, develop and update policies, procedures and standards of conduct. Responsible for the drafting, implementation and communication of policies and procedures. Partner with stakeholders to assess the need for and assist with periodic reviews of directives, policies and procedures. Conduct ongoing evaluations of monitoring and auditing outcomes, along with updates in laws, regulations, and industry standards (e.g., PhRMA Code), to proactively ensure policies and controls remain current and effective.
• Training, Education and Communications: In alignment with compliance objectives and Compliance program strategy, responsible for leading the Compliance training, education and communications program. Develop, implement, and execute all aspects of the compliance training program. Partner with the Compliance Team and business units to ensure appropriate and effective training and education across the organization. Assist with the development and delivery of appropriate trainings mapped to key risk areas. Lead the compliance communications program including the development of content and ensuring timely delivery of newsletters and compliance updates utilizing all available communication channels.
• Project Management: In partnership with the Director, identify and lead strategic projects designed to fulfill the needs of and enhance the effectiveness of the Lundbeck Compliance Program. Drive results-oriented process improvement.
• Risk Management: Support the Director in developing and implementing risk mitigation and enhancement plans; and (2) developing risk assessment protocols for ongoing review.
• Investigations: Assist with internal compliance investigations ensuring legal compliance and managing risk. Assist with escalations as needed. Enforce standards and ensure appropriate follow up action.
• Monitoring and Auditing: Implement effective auditing and monitoring programs and processes to ensure effectiveness of overall compliance program inclusive of policies and procedures, trainings, investigations, and other compliance initiatives.
• Third Party Management: Work with the Director to oversee vendors and third-party RFP processes. This includes managing budgets, reviewing, and verifying contract terms with Legal, reviewing invoices, and processing timely payments.
• Other Duties: Assist the Director and CCO with the preparation of reports, summaries and documentation for internal and/or external use and other duties as assigned.

REQUIRED EDUCATION, EXPERIENCE and SKILLS:

• Accredited Bachelor's degree.
• 6+ years of Compliance-related experience in the pharmaceutical, biotech or medical device industry or in a consulting firm that supports these industries
• Demonstrated knowledge and understanding of FDA rules and regulations and Fraud and Abuse Laws, such as the Anti-Kickback Statute and the False Claims Act.
• Strategic mindset and results-oriented problem-solving skills.
• Exceptional writing skills, with the ability to clearly articulate complex concepts and ensure accurate pull-through from policies and procedures.
• Ability to communicate effectively with individuals at all levels, internally and externally.
• Demonstrated experience managing projects and working with multi-functional teams.
• Proven skillset as a strong collaborator, problem solver and business partner.
• Proactive, self-starter with a strong sense of ownership and accountability.
• Demonstrated ability to work effectively in individual and team settings.
• Strong planning, analytical, organizational, and time management skills.
• Keen attention to detail.
• Ability to function in a fast-paced environment handling multiple tasks simultaneously.
• Experience in drafting, reviewing, and editing compliance-related documents and training materials.
• Demonstrated proficiency with Microsoft Office suite, including Excel, Word, and PowerPoint; Internet, or other systems tracking software.
• Technical aptitude and ability to quickly learn and adapt to new digital communication tools, such as Poppulo, for generating newsletters.

PREFERRED EDUCATION, EXPERIENCE AND SKILLS:

• 6+ years of Compliance-related experience in the pharmaceutical industry.

TRAVEL:

• Willingness/Ability to travel up to 15% domestically. International travel may be required.

 Apply here
Posted 5/6/2025

REGIONAL HEAD OF INVESTIGATIONS AND MONITORING, NORTH AMERICA - Sanofi
Location: Cambridge, MA US

About the Job
Ready to push the limits of what's possible? Join Sanofi in one of our corporate functions and you can play a vital part in the performance of our entire business while helping to make an impact on millions around the world.

This position is responsible for the successful management of Sanofi's North America Ethics & Business Integrity (E&BI) assurance program team, including Monitoring, Investigations and the Helpline. This supervisory position will work collaboratively with Global E&BI, Legal, People & Culture, Finance and other functional and business areas to detect, investigate and remediate concerns. Integral parts of this role include effectively analyzing and communicating results, findings, and themes to management, working with cross-functional teams to develop risk mitigation plans, and facilitating/promoting multiple ways to report concerns. The role will report to the VP, E&BI, North America and Global Specialty Care. This position oversees work conducted by direct reports and outside consultants. This role exercises independent judgment in assessing and providing strategic oversight of compliance-related matters.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities

• Provide day-to-day oversight of all elements of the North America E&BI assurance program
• Manage the NA Investigations, Monitoring & Helpline triage process and teams
• Supervise and conduct comprehensive and objective internal Compliance investigations
• Analyze outcomes and findings to identify themes and opportunities; coordinate and advise on remediation efforts
• Effectively and regularly communicate results, findings, themes and improvement opportunities to executives
• Manage the preparation of clear and concise written summaries and reports
• Ability to prioritize multiple investigations, investigative tasks, and responsibilities in a fast-paced environment, while maintaining positive collaborative relations with various senior stakeholders
• Set strategic Monitoring priorities, working closely with global E&BI, Internal Controls & Audit
• Integrate process digitalization and automation
• Work collaboratively with members of the global EB&I team to continuously improve Sanofi's compliance program.
• Maintain strict confidentiality and discretion
• Assist with aspects of Sanofi's Corporate Integrity Agreement compliance

About You
Required Educational Background and Job-Related Experience

• Proven experience leading and managing Assurance, Investigations or Monitoring functions focused on issues such as bribery, corruption, healthcare compliance, fraud and/or white-collar investigations.
• Experience in managing e-Discovery platform/s, data analytics, and forensic investigations
• Demonstrated ability to manage and lead change in a large, matrixed organization
• Minimum of 10 years of life sciences/pharmaceutical/healthcare experience
• Excellent written, oral, and presentation skills
• JD preferred

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.

Pursue progress. Discover extraordinary.

Progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let's pursue progress. And let's discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

 Apply here
Posted 4/26/2025

DIRECTOR, HEALTH CARE COMPLIANCE OFFICER - Johnson & Johnson
Location: Raritan, NJ US

Job Description
Johnson & Johnson is currently recruiting for a Director, Health Care Compliance Officer for the Innovative Medicine business with responsibilities for areas within the Global Commercial Strategy Organization (GCSO) and Global Business Development. This position is located in Raritan, NJ.

The Director, Health Care Compliance Officer will set strategic direction, provide oversight, lead compliance efforts, ensure an effective compliance and risk management program, and drive operational excellence across multiple therapeutic areas, brands and/or functions.

The Director will serve as an internal compliance expert to senior leaders and key stakeholders exercising judgment to mitigate business risk and manage the allocation of resources to support business initiatives and enterprise projects.

Responsibilities:
Provide strategic guidance and compliance support for assigned areas; provide HCC oversight for business activities based on risk profiles; partner with colleagues to ensure compliance with HCC laws, regulations and industry standards related to the strategy and promotion of health care products and services, interactions with health care professionals (HCPs) and/or government officials (GOs) related to a number of areas including but not limited to:

• Collaboration with business partners in the development and review of commercial and medical strategies, business plans, new business models, HCP/GO engagements, and company material to facilitate compliant growth.
• Serving as a member or ad-hoc partner to business leadership team(s) to represent HCC and provide input during strategy discussions and business planning. Providing regular updates to business leadership and collaborating with stakeholders to effectively anticipate, prevent, detect issues and correct violations of laws, regulations, or company policies.
• Performing risk assessment, root cause analysis, risk mitigation planning and execution, and regular risk reviews to ensure compliance program effectiveness.
• Fostering a culture of accountability at all levels of the organization with a focus on credo-based decision making and operational excellence.
• Partnering with business partners and HCC colleagues to ensure transparency reporting obligations are met.
• Identifying potential compliance risks and issues associated business activities and ensure involvement of appropriate individuals within HCC, Regulatory, Government Contracting & Compliance, Legal and other functions such as Finance and Human Resources to provide appropriate guidance, risk mitigation and assurance of mechanisms in place for identifying and appropriately disciplining instances of non-compliance and ensuring consistency in the application of disciplinary action.
• Identify and collaborate on compliance by design activities to integrate compliance-related requirements and controls into business processes and systems.
• Manage direct report(s), coaching employee(s) for success and supporting talent development.
• Work with industry associations and other external organizations, as applicable, to influence/develop industry policies and standards in close partnership with HCC Sector Leads, to help shape the external environment.
• Sponsor, lead and engage in a variety of tasks and project initiatives to advance Health Care Compliance and/or business-related goals.

Qualifications Required:

• Bachelor's degree is required
• 10+ years of business-related experience required
• 5+ years of experience in HCC or related compliance/risk management function (e.g. HCC, Legal, Regulatory, Quality, Finance)
• 2+ years of People Management experience with strong track record of people management with ability to lead and develop team
• Knowledge of relevant laws, policies, standards, financial or auditing practices and company business and policies. Knowledge about industry associations, their modus operandi and related policies is a plus.
• Experience in the development and/or implementation of a compliance program and risk management solutions in accordance with an organization's risk profile
• Excellent verbal and written communications skills
• Ability to advise senior leaders and stakeholders on business initiatives or complex issues
• Strong collaboration with demonstrated evidence of maintaining relationships and partnerships with peers and business partners and ability to influence across all levels of the business
• Broad business experience with working knowledge of commercial sales and marketing practices and medical affairs strategies for healthcare products and services
• Ability to analyze data and trends, and communicate complex information to all levels of the company
• Engaging and personable demeanor; self-directed, detail-oriented and motivated; demonstrate a high level of accountability, leadership, and decisiveness, the ability to lead projects, and the ability to work through ambiguity and prioritize and execute on multiple and frequently changing priorities
• Experience working in a matrix environment to deliver solutions which drive compliant growth.

Preferred:

• Master's degree in related field or other advanced degree
• Experience working with industry partners and/or governmental regulatory bodies
• Experience working as an HCC or GCC Officer
• Current Certified Compliance & Ethics Professional (CCEP®) and/or Certification in Healthcare Compliance (CHC®) status

The position is located in Raritan, NJ and will include regular travel between local company sites (approximately 20%), as well as occasional domestic/international travel.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center or contact AskGS to be directed to your accommodation resource.

 Apply here
Posted 4/16/2025

SENIOR DIRECTOR, LEGAL - US COMMERCIAL - Incyte
Location: Chadds Ford, PA US (4 days per week in office/1 day remote)

Job Description (Overview)
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)
The Senior Director, Legal - US Commercial provides regulatory, transactional, and general legal support to the U.S. commercial organization. The attorney will support various aspects of Market Access activities, including trade and distribution, contract strategy, communications, and patient access and support.

Essential Functions of the Job (Key responsibilities)

• Develops a thorough understanding of and familiarity with the company's business, its operations, its people, products, markets, facilities, customers and competitors and utilizes that knowledge in working with stakeholders to mitigate risks.
• Establishes a rapport and a constructive working relationship with business unit management and personnel at all levels to encourage and continue the proactive use of in-house legal counsel.
• Provides day-to-day legal advice and transactional support regarding a wide range of activities and programs related to the commercial and scientific activities in the United States, including:
• Draft, review, negotiate, and manage a robust set of contracts related to the distribution, dispensing, and reimbursement of pharmaceuticals, as well as services that relevant customers may provide.
• Review promotional and educational materials involving the Company's products via the Medical, Legal, Regulatory (MLR) process.
• Assess current legal trends and enforcement priorities in the rapidly evolving Market Access areas and communicate updates to clients in a timely fashion.
• Assess proposed service arrangements with Market Access customers and vendors.
• Analyze and apply knowledge of the various statutes, regulations and guidance documents applicable to proposed Market Access activities.
• Draft, review, and negotiate a variety of contracts including, but not limited to, master service agreements, consulting agreements, licensing agreements, and confidentiality agreements. As assigned, manage and/or direct the contracting work of contract specialists and oversee Legal's responsibility for contract administration for assigned business or medical/scientific areas.
• Identify training needs and provide legal training to employees and consultants.
• Identify, calibrate, and communicate nature and extent of risks associated with commercial and scientific activities for clear and consistent decision-making.
• Collaborate cross-functionally to proactively manage risks by understanding business goals and developing solutions with partners to achieve those goals.
• Build constructive working relationships and operates as an active member of both Global Legal and US commercial teams.
• Demonstrate leadership by seeking to improve ways for Legal to operate with an eye towards gaining efficiencies or similar enhancements.
• Handle such other legal matters as may be assigned by this person's direct supervisor and/or the head of the legal department.

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

• J.D. or equivalent as well as bar admission and active membership in good standing in at least one United States state bar.
• 7+ years of experience working as in-house legal counsel with a pharmaceutical or a biotechnology company, or in the life sciences practice group of a law firm. Legal experience addressing Market Access-related legal issues in a pharmaceutical company is preferred.
• A solid working knowledge of pharmaceutical Market Access practices as well as the statutes, regulations and guidance documents applicable to these activities (e.g., federal and state anti-kickback statutes, government price reporting statutes and regulations (Medicaid, 340B, Veterans Healthcare Act), OIG guidance documents and opinions, the Federal False Claims Act, and the Food, Drug and Cosmetic Act, regulations and guidance documents).
• Experience launching a drug product, as well as supporting sales and marketing with advertising, promotion, and labeling issues is preferred.
• Experience providing legal advice for a wide range of regulatory matters, including but not limited to, FDA and OIG regulations applicable to the pharmaceutical industry.
• Strong written and verbal communications skills, including the ability to communicate concisely, integrate legal and business knowledge, and provide balanced advice regarding risks.
• Strong attention to detail. Proficient with Microsoft Office suite of products.
• Ability to manage multiple tasks simultaneously, handle highly sensitive information appropriately, and flourish in a fast-paced environment.
• Excellent interpersonal skills, with the ability to interact in a professional manner with employees at all levels of the organization.
• Ability to travel within the United States, up to 10% of time.

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: http://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 4/15/2025

MANAGER, TRANSPARENCY AND AGGREGATE SPEND, GRC - Otsuka America Pharmaceutical, Inc.
Location: Princeton, NJ or Rockville, MD US

Job Summary
The Manager will report to the Associate Director, Transparency & Aggregate Spend, GRC and will oversee and ensure OAPI and OPDC compliance with state financial transparency laws in the U.S. and the European Federation of Pharmaceutical Industries and Associations (EFPIA) disclosure requirements, assist with financial transparency report in federal jurisdiction and provide additional support, as needed, to the Associate Director, compliance analytics and operations. This role is responsible for the accurate preparation, validation, and timely submission of state-level transparency reports and EFPIA reports while ensuring adherence to all relevant laws, regulations, and internal policies. This role involves close collaboration with various internal teams and external vendors to ensure data accuracy, timely reporting, and adherence to regulatory requirements.

Job Description

• Lead all aspects of the preparation, validation, and timely submission of state-specific financial and EFPIA transparency reports, ensuring compliance with reporting requirements
• Maintain a comprehensive understanding of evolving transparency laws, i.e. EFPIA and various state regulations, collaborate with Compliance counsel in monitoring changes in regulatory requirements and adjust reporting processes accordingly
• Responsible for collaborating with affiliates, internal stakeholders, including Finance, Legal, Compliance, and external vendors, to ensure accurate data collection and reporting within a timely manner
• Contribute to end-to-end management of financial transparency data quality errors and work with internal and external stakeholders to determine root causes, requirements, and resolutions
• Assist with Federal Reporting as needed
• Participate in daily activities related to Otsuka's global Aggregate Spend data collection efforts
• Manage relationships with key vendors responsible for data reporting and coordinate with vendors to resolve data discrepancies and reporting issues
• Escalate data integrity issues, as appropriate
• Support transparency reconciliation processes to ensure appropriate business review of data collected
• Monitor and analyze financial transparency data and trends and design and develop reports and presentations for cross-functional teams to provide analytic intelligence to identify potential risk areas, and develop an action plan/options for resolutions, as needed
• Identify opportunities to streamline reporting processes and enhance data quality through automation and technology improvements
• Assist management with utilization of current systems and tools to ensure accurate financial transparency data tracking and reporting (policy violation alert reports review, value assessment, etc.)
• Maintain a detailed log of all operational activities, requests, and communications
• Act as an independent reviewer of situations to help ensure the compliance issues within the Company are being reviewed and resolved in a timely fashion
• Supervise 1-2 individual contributors as needed to oversee training, development, and evaluation as needed to ensure optimal performance of state level and international reporting.
• Support healthcare law auditing and monitoring and investigations activities as needed
• Provide operational support to the Associate Director, as needed
• The role will evolve as the needs of the team and business are determined

Qualifications

Required

• Bachelor's Degree
• 4+ years of experience in applicable healthcare industry, including 2+ years state and EFPIA financial transparency reporting experience
• Knowledge and understanding of applicable U.S. state laws, regulations, codes and EFPIA disclosure requirements
• Experience working with large datasets, conducting data review, validation, and ensuring reporting accuracy
• Ability to manage multiple deadlines
• Strong analytical skills with high level of attention to detail
• Strong work ethic
• Ability to synthesize information from diverse sources
• Ability to read, analyze, and interpret business and regulatory information
• Ability to meet deadlines with minimal supervision, as a manager as well as a team member
• Proven track record in delivering results, self-starter and ability to manage complexity and ambiguities
• Strong written and oral communication skills
• Ability to multitask and prioritize work in a dynamic and changing environment
• High degree of proficiency with Microsoft Office Suites and ability to learn analytics technology tools

Preferred

• Experience working in a variety of systems (e.g., Concur, Aggregate Spend platforms, etc.)
• 5+ years of work experience in compliance function in the healthcare industry with 2+ years at manager level

Disclaimer
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.

 Apply here
Posted 3/20/2025

ASSOCIATE DIRECTOR, COMPLIANCE - Pharming Group N.V.
Location: This is a hybrid role; must be able to report to the Warren, NJ office, 2 to 3 days per week.

About Pharming
Pharming Group N.V. (Nasdaq: PHAR/Euronext Amsterdam: PHARM) is a global biopharmaceutical company dedicated to transforming the lives of patients with rare, debilitating, and life-threatening diseases. Pharming is commercializing and developing an innovative portfolio of protein replacement therapies and precision medicines, including small molecules, biologics, and proteins that are in early to late-stage development. Pharming is headquartered in Leiden, Netherlands, and has employees around the globe who serve patients in over 30 markets in North America, Europe, the Middle East, Africa, and Asia Pacific.

Our Culture
Pharming is committed to our core values: "We Care, We Collaborate, We Walk the Talk", which is complementary to our focus on self-development of our people, teamwork, leadership and being results orientated. In our growing organization, it is important that employees feel connected and engaged. Our core values enable our mission of bringing the unserved rare disease patients the solutions they need and create a clear pathway forward to meet our strategic goals and objectives.

Overview
Pharming is seeking to hire an Associate Director, Compliance to bring risk-based and comprehensive compliance strategies across Pharming's Commercial Sales, Market Access, Marketing, Medical and/or other related functions to provide guidance that will impact how key stakeholders will interact with customers and HCPs. Our goal is to have this individual help in leading the development, implementation, and continuous improvement of an effective compliance program. Successful execution will involve working collaboratively with Compliance leadership to ensure their areas of responsibility are aligned with Pharming's US Compliance program strategy and is effectively implemented, managed, and executed by Pharming personnel to prevent violations of applicable laws, regulations, industry codes, and policies that govern our Compliance program.

Key Responsibilities
The Associate Director, Compliance will be responsible for a wide variety of matters in support of Pharming's growth as we increase the number of both pipeline and marketed products.

Core functions include:

• Lead and direct management and oversight of US policies and procedures. This will include educating and influencing key stakeholders about new requirements during the development of new documents and updates to existing documents to meet the changing nature of business activities as well as the routine maintenance of effective control documents to ensure Pharming personnel have the resources to remain compliant.
• Lead the development and implementation of compliance training and education for US employees to ensure effective understanding and compliance.
• Oversight of the US portion of the Pharming Hotline and investigations including independently evaluating hotline and other source reports, conducting appropriate investigations and outcomes, and assisting with determining appropriate corrective action when necessary.
• Management and maintenance of the US Disclosure log, including analyzing data to determine trends, risks and reporting to senior management at regular intervals.
• Manage Healthcare Professional and Healthcare Institution engagement process for all HCP engagements by the Medical, Market Access and Commercial organization. Review and approve annual engagement plans and business need reviews for HCP and HCI engagements and other interactions incoming from the commercial, medical, and R&D functions.
• Manage the Fair Market Value process for all HCP engagements, train stakeholders, review requests and determine appropriate tiering of HCPs.
• Collaborate and assist on the following aspects of the compliance program:
• Compliance communications.
• Compliance Leadership engagement.
• Risk Assessment and Monitoring.
• Government Transparency Reporting.
• Vendor management.
• Enforcing Compliance Standard
• Partner with key stakeholders to independently advise, provide guidance on promotional and non-promotional materials and activities, scientific exchange, disease state, medical/scientific programs, and R&D activities to minimize company risk and facilitate compliance that is in alignment with applicable regulation.
• Provide clarity around policies and procedures required to ensure the complaint functionality of the commercial, medical, R&D, and other departments and personnel in their daily interactions with healthcare professionals, institutions, payors, and other groups.
• Collaborate with Global Compliance Colleagues to align activities, projects and initiatives with Pharming global Compliance standards, processes, and objectives.
• Identify compliance risk areas and create and implement novel approaches and action plans to address and mitigate the risk.
• Seek and embrace opportunities to evaluate and rethink how Compliance services are provided, focusing internal expertise on complex, high value matters, and automating, streamlining, or outsourcing high-volume, lower complexity matters, and using data to drive continuous improvement in services.
• Act as a representative on select cross functional teams or Committees as assigned for matters relating to Commercial Compliance including task forces. Contribute to the discovery, development, and delivery of our products to our patients and customers
• This is a hybrid role; must be able to report to the Warren, NJ office, 2 to 3 days per week.

Minimum Qualifications

• Bachelor's Degree with 8+ years' experience.
• 3+ years' experience in Compliance focused on activities within Commercial Sales, Market Access, Marketing, and Medical for the pharma/biotech industry.

Preferred Qualifications

• Experience identifying, creating, and implementing novel approaches to mitigate risk.
• Commitment to ethical conduct; ability to handle confidential and proprietary information using excellent discretion and judgment.
• Strong interpersonal skills with ability to develop and maintain effective cross-functional relationships with stakeholders.
• Excellent communication skills, both written and verbal.
• Ability to work both independently and collaboratively.

Salary Range
Pharming takes into consideration a combination of candidate's work experience, training, and education, as well as the scope of the role, complexity, and external market and internal value when determining a salary level.

The base salary range for this job is from $150,000.00 to $175,000.00 per year.

Compensation & Benefits

• Flexible hybrid work schedule to promote a health work-life balance.
• Competitive compensation package including annual target bonus.
• Long-Term Incentive Program
• 401(k) plan with company match
• Paid-Time Off Days
• 16 Company Holidays per year (typically last week of December up until New Year's Day)

Other Benefits

• Excellent Healthcare Plans including Medical, Dental and Vision.
• Flexible Spending Accounts for Medical and Dependent Care.
• Company-provided Life Insurance, Short-Term and Long-Term Disability Plans.
• Accident, Hospital Indemnity and Critical Illness Plans.
• Pet Insurance Plan.
• On Premise Fitness Center.
• Health & Wellness Program.
• Choice of Mobile Phone for Work Use or Cell Phone Stipend.
• Pharming Academy - Continuing Learning & Development Program.

Additional Information
Pharming is committed as an Equal Opportunity and Affirmative Action employer for all employees and qualified applicants without regard to race, color, sex, gender identity or expression, genetic information, sexual orientation, marital status, race, religion, color, national origin, disability, protected Veteran status, age, or any other characteristic protected under applicable law.

An applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request via email to HR-US@pharming.com.

Unsolicited resumes from agencies should not be forwarded to Pharming. Pharming will not be responsible for any fees arising from the use of resumes through this source. Pharming will only pay a fee to agencies if a formal agreement between Pharming and the agency has been established. The Human Resources/Talent Acquisition department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

Please note that we review every submission, and we will keep submissions on file for six months.

 Apply here
Posted 3/13/2025

DIRECTOR COMPLIANCE BUSINESS PARTNER FOR OUR U.S. MEDICINE AND INNOVATION (R&D) UNITS - Boehringer Ingelheim
Job flexibility: Hybrid/ Primary location: Ridgefield, CT US

Description
Join us on our journey at Boehringer Ingelheim boehringer-ingelheim.com. We develop leading Animal and Human Pharma products around the world and are looking for a Director Compliance Business Partner for our U.S. Medicine and Innovation (R&D) Units. Our research into new medicines is focused on those of areas of science with significant medical need and where we continue to innovate and lead the science in multiple therapeutic areas with multiple innovative product launches on the horizon. We are concentrating our research efforts and investment in: Cardio Metabolic diseases; Central Nervous System diseases; Immunology and Respiratory diseases; Oncology and Cancer Immunology and Retinal health with innovative products to benefit patients around the world.

As a Compliance Business Partner (CBP), you will have an outstanding opportunity to integrate with various functions and therapeutic areas to support their future business success. A successful CBP will partner and develop trusted relationships with senior level leaders across various Medicine & Innovation (R&D) functions or Therapeutic Areas, provide solution-oriented advice on daily operations, verify that appropriate compliance controls and training are in place, and support the lifecycle of BI products from pipeline through post-launch. You will be viewed as a true partner to various functions and therapeutic areas you support.

This role has a flexible hybrid onsite work schedule in our Ridgefield, CT headquarters dependent on business needs.

Compensation Data
This position offers a base salary typically between $170,000 and $269,000. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here.

Duties & Responsibilities
Act as a Compliance Business Partner for U.S. Medicine & Innovation Unit (R&D)

• Be the key point person and subject matter expert for relevant medical and commercial compliance topics by providing timely and practical healthcare compliance counseling and support to the business with an understanding of how U.S. compliance requirements apply to daily operations.
• Proactively identify and provide solutions on potential risks across the lifecycle of Boehringer product drug development, from pre-clinical through post launch advising on compliance insights and recommendations.
• Provides advice and proposed solutions on compliance and integrity matters relating to Medicine & Innovation Unit or Therapeutic Areas, and on a wide range of issues impacting those groups, to senior leaders, both in the U.S. and globally
• Collaborate to create a culture of compliance
• Propose innovative solutions to achieve Boehringer objectives, enabling smart risk-based decision-making within ethical boundaries and optimizing business performance.
• Provide insight into external industry and compliance environment and recommend best practices and process improvements to stay ahead of the curve of changing industry dynamics
• Support operationalization of compliance processes and executing within legal and compliance-related requirements in collaboration with cross-functional teams. Participate as a strategic advisor in annual strategic and tactical planning sessions with local and corporate stake holders

Be the Expert

• Understand macro and micro implications of the business challenges and potential solutions including assisting with the risk / benefit analysis.
• Be a CBP for key areas which may include therapeutic areas and/or other important medical or R&D functions.
• Serve as an integral liaison with corporate partners and colleagues to support the conduct of global activities that implicate U.S. laws and regulations.
• Utilize your subject matter expertise to plan, develop, and execute training to close knowledge gaps and address larger trends
• Lead or support activities for Medicine & Innovation Unit and Commercial (as needed)business partners such as: therapeutic areas risk assessment and strategic planning, training and communication, innovative health care provider interaction initiatives, and development of ethical business culture.
• Identify areas of compliance risk in respective business areas, including but not limited to topics of Transparency & Disclosure, Anti-Bribery and Anti-Corruptions (ABAC), and compliance operations, and ensure that systems, policies, procedures, training, and other resources are coordinated to mitigate risk to impacted business areas.
• Design, develop and implement healthcare compliance policies, standard operating procedures, and guidance documents in collaboration with cross-functional teams.
• Assist business in remediating findings from investigations, audits, monitoring, and other assessments, keeping applicable team members apprised of relevant information.

Requirements

• Bachelor's Degree in Business or related area.
• Strong background working with R&D, Medicine or related business groups
• Strong performance history including 8 years of experience with a similar business area in a pharmaceutical, life sciences or similar setting.
• Strong interpersonal management skills and experience.
• Demonstrated ability to critically analyze and assess business and regulatory information and effectively communicate at all levels in the organization.
• Proven ability to lead and influence diverse groups.

Desired only…

• Master's or Law Degree

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.

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Our Company
At Boehringer Ingelheim we develop breakthrough therapies that improve the lives of both humans and animals. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective. Now, we are powered by 52,000 employees globally who nurture a diverse, collaborative and inclusive culture. We believe that if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve.

Why Boehringer Ingelheim?
With us, you can grow, collaborate, innovate and improve lives.

We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mindsets and practices. In addition, learning and development for all employees is key, because your growth is our growth.

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.

Want to learn more? Visit https://www.boehringer-ingelheim.com/us/careers.

Explore our total rewards here: Visit https://www.boehringer-ingelheim.com/us/careers/benefits-rewards. 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 3/10/2025