POST A POSITION
For information about placing your employment listing on this page, email: info@pharmacomplianceforum.org.
Cost is complimentary for PCF Members and $600 for 90 days for non members.

EMPLOYMENT OPPORTUNITIES

 

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.

#LI-AP1

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

SENIOR CORPORATE COMPLIANCE DIRECTOR, RISK MANAGEMENT - United Therapeutics
Location: remote within the US

Who we are
We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.

United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF).

The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.

Who you are
You are an analytical thinker with a keen eye for detail and a proactive approach to risk mitigation. You are data-driven and methodical, and able to translate complex compliance insights into clear, actionable next steps. With a natural curiosity and problem-solving mindset, you thrive on uncovering trends, identifying gaps, and strengthening controls. You are comfortable as both a strategist and an executor—designing monitoring programs, overseeing audits, and driving corrective actions to completion. As a leader, you provide guidance and mentorship to your direct report, fostering precision, accountability, and continuous process improvement. With a blend of technical expertise, business acumen, and a commitment to ethical standards, you ensure the organization stays ahead of compliance risks and responds effectively and efficiently.

The Senior Corporate Compliance Director, Risk Management reports to the Chief Compliance Officer and is responsible for leading the Department's risk management activities. The Senior Corporate Compliance Director will develop the auditing and monitoring strategy for the Department, and will lead the execution of the annual auditing and monitoring plans. In addition, they will oversee and administer the investigations process, as well as all corrective action stemming from auditing, monitoring and investigations in conjunction with the Compliance Business Partners, as appropriate. The Senior Corporate Compliance Director will lead also the annual RAMP (Risk Assessment and Mitigation Process) for United Therapeutics, and will manage at least one direct report.

Minimum Requirements

• 15+ years of experience in pharmaceutical/biotechnology corporate compliance roles, with progressive experience within compliance monitoring, auditing, and investigations with a Bachelor's Degree or
• 13+ years of experience in pharmaceutical/biotechnology corporate compliance roles, with progressive experience within compliance monitoring, auditing, and investigations with a Master's Degree
• 8+ years of experience in managing direct reports
• Ability to build professional relationships with internal customers and partners
• Skilled at detecting and presenting trends/patterns related to auditing, monitoring and investigation findings; Capacity to do this in a detailed and high level manner, dependent upon audience
• Demonstrated knowledge of regulatory/compliance requirements including the Anti-Kickback Statute, False Claims Act, FCPA, Sunshine Act, HIPAA and other regulations
• Ability to act with a sense of urgency, with high motivation and ability to take initiative, follow through and complete projects in a professional and expeditious manner
• Strong collaborative, interpersonal and oral communication skills
• Ability to handle confidential matters with discretion and solid judgement
• Ability to produce high quality work with minimal oversight from manager
• Strong analytical and problem-solving skills, as well as attention to detail
• Excellent written communication skills, including robust and advanced documentation practices
• Ability to travel up to 30%

Preferred Qualifications

• Master's Degree in a related field
• Proficiency with Smartsheet and Power BI

Job Location
United Therapeutics has the flexibility to hire this role remotely within the United States. At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good.

The salary for this position ranges from $202,000 to $290,000 per year. In addition, this role is eligible for the Company's short-term and long-term incentive programs. The salary range is the range United Therapeutics Corporation in good faith believes is the range of possible compensation for this role at the time of this posting depending on the candidate's experience, qualifications, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range. This range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.

 Apply here
Posted 2/25/2025

COMPLIANCE MANAGER, MONITORING, AUDITING & RISK - Chiesi
Location: Cary, NC, US
Date: Feb 7, 2025
Department: Legal & Corporate Affairs
Job Type: Direct Employee
Team: Legal, Compliance & Internal Audit
Contract Type: Permanent

About us
Based in Parma, Italy, Chiesi is an international research-focused pharmaceuticals and healthcare group with over 85 years' experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). To achieve its mission of improving people's quality of life by acting responsibly towards society and the environment, the Group research, develops and markets innovative drugs in its three therapeutic areas: AIR (products and services that promote respiration, from new-born to adult populations), RARE (treatment for patients with rare and ultra-rare diseases) and CARE (products and services that support special care and consumer-facing self-care).

We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes transparent ethical behavior at all levels.

We are committed to embrace diversity, inclusion and equal opportunities. In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.

Chiesi USA
Chiesi USA is a specialty pharmaceutical company focused on developing and promoting products for the hospital, adjacent specialty and rare disease markets. We are a B Corp™ and Benefit company awarded Top Employer status for six consecutive years and certified as a Great Place to Work. At Chiesi, we share an entrepreneurial spirit and act as a force for good, pursuing high social and environmental standards, to ensure the wellbeing of our people, patients, and communities. We offer a work environment where professionals have the opportunity to build a purposeful career focused on helping others while achieving a fulfilling work-life balance, meeting exciting challenges, and engaging in important and rewarding work.

What we offer
Chiesi offers competitive benefits, services, and programs that enrich the personal and professional lives of our employees. Our shared values of passion, innovation, trust and integrity bring out the individual talents and diverse perspectives of each of our colleagues. Our environment encourages each individual to reach his or her full potential and drive outstanding results. We celebrate that "Every one of us is different. Every one of us is Chiesi."

Who we are looking for

Purpose
The Lead, Compliance Monitoring, Auditing, and Risk plays a crucial role in ensuring that an organization adheres to all relevant laws, regulations, and internal policies; identify risks; and determine ways to mitigate those risks. The position will work a hybrid model out of our Cary, NC office.

Main Responsibilities

• Audit Management: Complete, oversee, and/or manage internal audits to ensure compliance with company policies, regulatory requirements, and industry standards. This includes planning, executing, and reporting on audits.
• Risk Assessment: Working with the Compliance Committee and the Compliance Team, conduct risk assessments to identify potential compliance risks and develop strategies to mitigate these risks. This involves evaluating the effectiveness of existing controls and recommending improvements.
• Monitoring and Reporting: Monitor compliance with company policies and regulatory requirements. This includes preparing reports on compliance activities, including speaker programs and congresses, and presenting findings to the Compliance Committee.
• Policy Development: In conjunction with the Compliance lead for learning and development, develop and implement compliance policies and procedures to ensure adherence to legal and regulatory requirements. This includes updating policies as needed to reflect changes in regulations or company operations, and assist with training modules on those policies.
• Collaboration: Work closely with other departments, such as Legal, Finance, and Information and Communication Technology (ICT) to ensure a coordinated approach to compliance and risk management. Assist Compliance Team on various initiatives as needed. Actively contribute to the sustainability goals to further the impact on patients, customers, employees, community and the planet by demonstrating a shared value mindset.

Experience Required

• 3-5 years of experience in audit or risk management in pharmaceutical compliance. Experience in the pharmaceutical or healthcare industry is a plus.
• Strong analytical and problem-solving skills, excellent communication and interpersonal skills, and the ability to work independently and as part of a team. Proficiency in using compliance and audit software is also important.
• Demonstrated proficiency in Written, Verbal and Face-to-face communication to effectively present information to and influence decision making of managers, working partners (local and global), and government agencies.
• Ability to successfully manage multiple tasks and multifunctional resources concurrently while maintaining high attention to detail while responding to rapidly changing priorities and aggressive deadlines.
• Proficient in MS Office (Word, Excel, Teams, Copilot)

Education
A bachelor's degree in a related field, such as business, finance, or law. A master's degree or professional certification (e.g., Certified Internal Auditor, Certified Compliance and Ethics Professional) is preferred. Chiesi USA is an equal opportunity employer committed to hiring a diverse work force at all levels of our business.

All qualified applicants receive consideration for employment without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, veteran status, gender identity or expression or any other basis protected by local, state or federal law. This policy applies with regard to all aspects of one's employment, including hiring, transfer, promotion, compensation, eligibility for benefits and termination.

 Apply here
Posted 2/10/2025

SENIOR MANAGER, COMPLIANCE PROGRAM EFFECTIVENESS - Insmed
Position Location (WD) : Location: Bridgewater, NJ US
Remote: Yes
External ID: R2010
Job Function: Compliance
Salary Range: 119000-167267

Company Description
Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion. Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.

RECOGNITIONS

Consistently Ranked Science's Top Employer
Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we've been named the No. 1 company to work for in the biopharma industry in Science's Top Employers survey for four years in a row.

A Certified Great Place to Work®
We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, PEOPLE® Companies That Care, Best Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.

Overview
Our Global Compliance Team is a group of real, friendly, experts in our field. Our mission is to be trusted business partners, managing risk and co-creating solutions. We work every day to empower the business, resource the risk, and drive impact.

Responsibilities
About the Role:
Do you like to think big and get stuff done? Do you enjoy owning strategic projects, rallying stakeholder support, and leading through change? Want to be a part of an expert team that makes a difference while having fun? Come join us!

This role is responsible for measuring and advancing the effectiveness and maturity of our compliance program. You will be responsible for project management, change management, and communications associated with strategic compliance projects. You will engage collaboratively with Compliance and other cross-functional colleagues to deliver outcomes that are on-time, on-target and high-impact.

We don't expect someone to know it all. We want someone who enjoys being exposed to everything and connecting the dots to inspire change. Your responsibilities will include, but not necessarily be limited to, the following:

• Project management of strategic compliance initiatives. Driving projects that are on-target, on-time, and on-budget.
• Lead change management efforts related to compliance initiatives. Including stakeholder engagement, communications, and training.
• Measure and assess the effectiveness of compliance initiatives relative to regulatory expectations and industry benchmarking. Document our compliance successes and identify improvement opportunities.
• Collect and report metrics that drive impactful compliance outcomes.
• Support the development of compliance-related presentations and dashboards for department and company leadership.
• Interpret regulatory developments and industry trends, providing insights and recommendations to enhance compliance strategy.
• Drive alignment of compliance initiatives across regions and departments, fostering a collaborative and coordinated approach that aligns to our department mission.
• Provide ad-hoc support to compliance team members on initiatives across the elements of compliance: risk assessment, monitoring, training, written standards, system enhancements, etc.
• Drive Insmed's 'continuous improvement' approach and culture of compliance.

Preferred Knowledge and Experience:

• Experience evaluating compliance program effectiveness (DOJ's Evaluation of Corporate Compliance Programs, OIG's General Compliance Program Guidance, OIG's Measuring Compliance Program Effectiveness Resource Guide)
• Experience with project management, change management, and communicating new initiatives
• Experience across the pharmaceutical compliance elements: written standards, training, effective communication, risk assessment, auditing, monitoring, and corrective action.
• Knowledge of US, Japanese, and European compliance regulations, laws, and standards
• Experience in communicating with and influencing mid-level and senior-level management

Basic Qualifications:

• Bachelor's degree required.
• Advanced degree or certification is a plus, specifically in project management, healthcare compliance, law, or business.
• 5+ years of experience in pharmaceutical compliance and/or project management

Skills:

• Organization, project management, critical thinking, strategic vision and tactical execution
• Must have excellent written and verbal communication skills
• Highly organized with a strong attention to detail, clarity, accuracy, and conciseness.
• Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook)
• Exposure and willingness to innovate with data analysis and artificial intelligence (e.g., pivot tables, PowerBI, large language models, etc.)

Other:

• Must successfully exhibit Insmed's five (5) core corporate values of: Collaboration, Accountability, Passion, Respect and Integrity; along with any other position specific competencies.
• Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace

#LI-JT1#LI-Remote
Salary Range: 119000-167267

Compensation & Benefits
We're committed to investing in every team member's total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including:

• Flexible approach to where and how we work, regionally based
• Competitive compensation package including bonus
• Stock options and RSU awards
• Employee Stock Purchase Plan (ESPP)
• Flexible Vacation Policy
• Generous paid holiday schedule and winter break

ADDITIONAL U.S. BENEFITS:

• 401(k) plan with company match
• Medical, dental, and vision plans
• Company-provided Life and Accidental Death & Dismemberment (AD&D) insurance
• Company-provided short and long-term disability benefits
• Unique offerings of pet, legal, and supplemental life insurance
• Flexible spending accounts for medical and dependent care
• Accident and Hospital Indemnity insurance
• Employee Assistance Program (EAP)
• Mental Health on-line digital resource
• Well-being reimbursement
• Paid leave benefits for new parents
• Paid time off to volunteer
• On-site, no-cost fitness center at our U.S. headquarters

Additional Information
Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

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

Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at TotalRewards@insmed.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

Applications are accepted for 5 calendar days from the date posted or until the position is filled.

 Apply here
Posted 2/5/2025

SENIOR MANAGER, HEALTHCARE COMPLIANCE OFFICER - Johnson & Johnson Services Inc.
Location: Raritan, NJ US; Horsham, PA US; New Brunswick, NJ US; Titusville, NJ US
Function: Legal & Compliance
Sub function: Health Care Compliance
Category: Senior Manager, Health Care Compliance (P8)
Date posted: Feb 04 2025
Requisition number: 2506234911W

Johnson & Johnson Services Inc. is currently recruiting for a Senior Manager, Health Care Compliance Officer for the Innovative Medicine Global Functions organizations, which is comprised of Global Commercial Strategy Organization and Global Business Development. This position will be based in Raritan, NJ (with regular travel to Titusville, NJ).

The Senior Manager, Health Care Compliance Officer, will be responsible for collaborating with Johnson & Johnson Global Innovative Medicine business partners and providing strategic guidance on Commercial and Medical activities and processes that have health care compliance-related implications. The Health Care Compliance Officer will provide direction and oversight of the Health Care Compliance (HCC) Program for multiple products within Global Johnson & Johnson Innovative Medicine and ensure the business integrates health care compliance and corporate integrity principles into strategic plans and tactics.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

Key Responsibilities:

• The Health Care Compliance Officer is responsible for the review of commercial strategies, transactions and material to facilitate compliant growth and ensure that programs comply with company policies and procedures including the Healthcare Regulatory Guidance Documents for Promotional & Marketing Practices, industry standards and applicable state and federal laws.
• Providing guidance, policy interpretations and recommendations relating to business activities.
• Perform risk assessment mitigation process and advising Business Management of potential compliance risk areas and recommended action plans.
• Anticipate potential problems and proactively take appropriate steps.
• Oversee the creation of appropriate tracking mechanisms based on problem identification; provide clarity around the ambiguities of the evolving HCC environment.
• Assess compliance-related educational needs formulate and facilitate compliance training programs for all employees, agents, affiliated providers, or others working with the Business.
• Ensure accountability for compliance through risk assessment, problem identification, corrective action & controls implementation, oversight & monitoring, investigation and follow-ups in alignment with relevant HCC processes and systems.
• In consultation with the Health Care Compliance Officer Director/Sr. Director, Human Resources, and the Law Department, responsible for ensuring there is a mechanism in place for appropriately addressing instances of non-compliance and ensuring consistency in the application of disciplinary action.
• The Health Care Compliance Officer, in conjunction with the Health Care Compliance Officer Director/Sr. Director will be accountable for communicating company healthcare compliance standards and information updates on new laws and guidance to committee members, key business partners and agencies.
• The Health Care Compliance Officer will be accountable for communicating company healthcare compliance standards and information updates on new laws and guidance to committee members, key business partners and agencies.

Qualifications:
Education:

• A minimum of a Bachelor's degree is required.

Experience and Skills:
Required:

• A minimum of 8 years of business-related experience required.
• 5 years of experience in the healthcare industry with knowledge of Health Care Compliance programs and policies, Federal health care programs, and FDA requirements required.
• Strong track record of working in a collaborative environment with demonstrated evidence of maintaining relationships and partnerships with peers and business partners and leaders.
• Broad business experience and a proven ability to influence business decisions and business partners.
• Demonstrated ability to think strategically, analyze data and trends, and communicate complex information to all levels of the company required.
• Qualified candidates will have an engaging and personable demeanor; be self-directed, detail-oriented, and motivated; demonstrate a high level of accountability, leadership, and decisiveness and the ability to prioritize, and execute on multiple and frequently changing priorities.
• Knowledge of commercial sales, marketing, and Medical Affairs practices for healthcare products.
• Experience working in a matrix environment to deliver solutions which drive compliant growth.

Preferred:

• Experience working with the governmental regulatory bodies and managing HCC company policies is preferred.
• Experience working as an HCC or GCC Officer or Manager is preferred.
• Experience developing and implementing one or more elements of a compliance program in accordance with an organization's risk profile is preferred.
• CCEP accreditation preferred.

The anticipated base pay range for this position is 120000 to 207000.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.

• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
• Employees are eligible for the following time off benefits:- Vacation - up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
• Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
• Additional information can be found through the link below.

https://www.careers.jnj.com/employee-benefits.

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

 Apply here
Posted 2/5/2025