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EMPLOYMENT OPPORTUNITIES

 

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.

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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

EXEC. DIRECTOR, CORPORATE COMPLIANCE BUSINESS PARTNERING - BioCryst
Location: Remote
Department: Legal

At BioCryst, we share a deep commitment to improving the lives of people living with complement-mediated and other rare diseases. For over three decades we've been guided by our passion for not settling for "ordinary" in our quest to develop novel medicines. We leverage our expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and protein therapeutics, led by the efforts of our team of expert scientists in our Discovery Center of Excellence in Birmingham, Alabama. Our global headquarters is in Durham, North Carolina, our European headquarters is in Dublin, Ireland and our employees span the globe across sites in multiple countries. We are proud of our culture of engagement and accountability that rewards people for innovative thinking and achievement of key objectives. For more information, please visit our website at https:www.biocryst.com or follow us on LinkedIn and Instagram.

JOB SUMMARY:
The Exec. Director, Corporate Compliance Business Partnering will be a key part of BioCryst's compliance team and will collaborate with other internal and external stakeholders as necessary to ensure global compliance at BioCryst with a high degree of independence. The ideal compliance professional will possess solutions-oriented pragmatism, as well as excellent communication skills and attention to detail to be able to work in a cross functional capacity in order to continue building a best-in-class compliance program. This will be accomplished by influencing values-based decision making and driving accountability in partnership with business leaders to generate trust from customers, business partners, and patients.

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Provide strategic oversight of global business partnering functions to provide turnkey, consistent, sustainable compliance business partner support
• Lead and manage current compliance business partner employees, covering countries with various considerations while ensuring consistent ways of working
• Provide direct business partnering consult to countries and functions as assigned
• Sustain and evolve a continually proactive approach to global compliance
• Build and maintain relationships with regional leadership, constantly surveying/improving business partnering processes so the program drives confidence and competitiveness, as well as compliance
• Harmonize compliance approach to risk management across all markets
• Create relevant tools, templates, and dashboards for consistent use in compliance business partnering and in communications with Legal leadership team
• Oversee in-country vendors and consultants for the purpose of ensuring global consistency
• Collaborate closely with Global Compliance Operations for projects including but not limited to training, policies, monitoring, transparency, communications, etc. to ensure seamless approach to overall global compliance
• Responsible for right-sized compliance support considerations and proposals as the company expands into additional markets in the future
• Travel up to 20% as required
• Other duties as assigned

EXPERIENCE & QUALIFICATIONS:

• Bachelor's degree in related field
• 10+ years of experience within Compliance or related field with a minimum of 5 years direct Compliance business partnering experience within the Pharmaceutical/Biotech industry
• Strong knowledge of applicable laws, rules, and regulations, including but not limited to, FDA, OIG, CMS, PhRMA/EFPIA/IFPMA, Open Payments/global transparency reporting, anti-kickback, fraud and abuse, anti-bribery, antitrust, privacy and product liability laws, rules, regulations and guidance
• Ability to contribute to decision-making affecting compliance approach, understanding and executing business strategy and goals
• Demonstrated pragmatism and operational focus, while maintaining a strategic mindset, seeking to assist others in finding practical, business solutions.
• Sound, agile decision-making and interpersonal/networking skills to lead and work effectively in a team environment.
• Ability to negotiate conflict and maintain constructive working relationships with people at all levels of the organization
• Ability to multi-task and set priorities within a rapidly changing environment
• Demonstrated ability to interact with and influence key stakeholders
• Excellent interpersonal, coaching and mentoring skills
• Excellent verbal and written communication skills

The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time.

BioCryst is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, BioCryst is committed to achieving its business objectives in compliance with all federal, state and local law.

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Posted 1/23/2025

DIRECTOR FIELD COMPLIANCE AND INVESTIGATIONS - Lundbeck Pharmaceuticals
Location: Deerfield, IL US

SUMMARY:
The Director, Field Compliance and Investigations will have direct responsibility for and assist with driving and implementing all elements of the Lundbeck Compliance Program, which are modeled after the seven elements of an effective compliance program. This role will focus on: (1) dedicated, strategic partnership with the business unit field-based teams, including sales and medical science liaisons; and (2) lead, manage and be responsible for all internal compliance investigations. This role will develop and implement Lundbeck's field compliance risk mitigation strategy, work with commercial and medical leadership to continually identify and mitigate compliance risks and work closely with key stakeholders and partner with lines of business (LOB) in support of field-based compliance and overall business objectives across the entire Business unit brand portfolio.

Essential Functions:

• People Management: Manage matrix relationships with stakeholders across the entire organization to provide compliance guidance and drive an ethical and compliant culture in support of business objectives. Provide direction and feedback to other members of the Compliance team in relation to field compliance.
• Investigations: Effectively lead, oversee and manage all internal investigations, while ensuring legal compliance and managing risk. Conduct internal investigations and manage disclosure log relating to alleged compliance violations. Partner with the CCO and Human Resources (HR) to recommend follow-up and appropriate corrective action. Perform quarterly audit and gap and trend analysis to develop risk mitigation strategies.
• Field Compliance Oversight: Identify and lead strategic projects designed to ensure field compliance with policies and procedures. Responsible for strategy, trend and gap analysis, programs, policies, monitoring, training and corrective actions in support of promotional and MSL compliance for the field.
• Field Risk Mitigation & Strategy: Develop and implement field compliance risk mitigation strategy including ongoing risk assessments, gap and risk analysis and results-oriented risk mitigation plans in support of field compliance and to determine effectiveness of Compliance trainings, education and other initiatives.
• Dedicated Business Partnership: Develop and maintain trusted partnerships and effective lines of communication across the business unit commercial and medical organizations. Serve as a dedicated business partner to the field, including senior leadership. Proactively provide guidance and support to all business unit commercial and medical stakeholders across the organization on compliance matters. Participate in cross-functional initiatives and meetings.
• Policies, Procedures and Controls, including Code of Conduct: Responsible for ongoing maintenance and updates to steering documents, policies and procedures. Partner with LOB to assist with reviews, development and updating of directives, policies and procedures.
• Training, Education and Communications: Implement the compliance training program in accordance with company directives, policies and procedures. Partner with global compliance, LOB and the commercial and medical organizations to develop, maintain, and ensure appropriate training content, training matrices and training calendars. Deliver appropriate training content and coaching to ensure standards are clearly communicated to employees. Provide support for compliance communications program.
• Monitoring and Auditing: Develop and oversee field-based auditing and monitoring plans to ensure compliance with Lundbeck's policies and procedures. Conduct field monitoring, data reviews and audits of key compliance risk areas, in accordance with the US monitoring program. Work with other departments to perform additional auditing related to healthcare compliance. Monitor field-based communications (commercial and medical), sponsorships, HCP exhibits, ad boards, conferences, HCP engagements, and FMV analysis and conduct related investigations. Draft reports and identify appropriate follow-up and risk mitigation initiatives. Assist with all auditing and monitoring programs and processes to ensure effectiveness of overall compliance program. Develop data dashboards in support of predictive analytics and risk management initiatives. Prepare and present monitoring and auditing results to Compliance Committee on periodic basis.
• System Ownership: Serve as system owner for compliance program management software.
• Third Party Management: Oversee vendors and third-party RFP processes. This includes reviewing vendor effectiveness, managing vendor relationships and performance reviews, identifying and evaluating new vendors as needed, managing budget, reviewing and verifying contract terms with Legal, reviewing invoices, and processing timely payment.
• Advice, Guidance and Other Duties: Drive a compliant culture. Stay abreast of relevant laws and regulations and perform industry benchmarking as to Compliance oversight program. Proactively provide day-to-day guidance to business unit commercial and medical field-based teams on compliance matters. Implement and execute all obligations in support of government investigations and agreements, as assigned by CCO. Provide support to US compliance team and global compliance, as needed. Assist the CCO with the preparation of reports, summaries and documentation for internal and/or external use. Execute other duties as assigned by the CCO.

Required Education, Experience, and Skills:

• Accredited bachelor's degree.
• 10+ years of Compliance-related experience in the pharmaceutical, biotech or medical device industry.
• 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.
• Ability to communicate effectively and professionally with individuals at all levels, internally and externally.
• Demonstrated experience managing projects and working with multi-functional teams.
• Experience in development of training and curriculum design, including delivery and implementation of training and workshops.
• 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.
• Strong attention to detail.
• Ability to function in a fast-paced environment handling multiple tasks simultaneously.
• Demonstrated proficiency with AI tools and Microsoft Office suite, including Excel, Word, and PowerPoint; Internet, or other systems tracking software.
• Experience administering live web meetings and training sessions with Zoom, Microsoft Teams, WebEX, GoToMeeting/GoToWebinar, Lync, or other webinar software.

Preferred Education, Experience, and Skills:

• 10+ years Compliance-related experience in the pharmaceutical industry.
• Hands on experience supporting a learning management system and/or compliance program management software.
• Experience building and performing analysis using data dashboards.
• Experience drafting and updating policies and SOPs.
• Product, marketing, or sales management experience.

Travel:

• Willingness/Ability to travel up to 20% domestically. International travel may be required.

 Apply here
Posted 1/11/2025

DIRECTOR, GOVERNANCE, RISK MANAGEMENT & COMPLIANCE OPERATIONAL AUDITOR - Otsuka America Pharmaceutical
Full Time
Location: Princeton, NJ US; Hybrid

Job Summary
Following the implementation of the Governance, Risk Management, and Compliance (GRC) program and Enterprise Risk Management (ERM) Assessment in the U.S., this new role is being created to continue to develop the U.S. Ethics & Compliance (E&C) operational audit program strategy and optimize our U.S. compliance risk assessments.

The Director, Governance, Risk Management & Compliance Operational Auditor will oversee and lead the development and execution of the operational audit strategy and report on operational audits of compliance and enterprise risks for Otsuka America Pharmaceutical, Inc. (OAPI) and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), collectively Otsuka. Additionally, this role will oversee and optimize the U.S. compliance risk assessment processes. This is a key role to continue to support U.S. E&C's GRC function and the Vice President & U.S. Chief Compliance Officer in executing an effective compliance program.

Job Description
The Director, Governance, Risk Management & Compliance Operational Auditor will be responsible to:

• Develop, implement, and oversee the Otsuka operational audit strategy and program that assess the design and effectiveness of internal controls and identifies potential control gaps that may require remediation for Otsuka's enterprise and compliance risks.
• Develop and maintain the annual audit plan (and audit universe) through engagement with senior leaders in U.S. E&C and other key Otsuka business stakeholders to ensure it is focused on the highest-risk activities and remains fit-for-purpose.
• Oversee and lead operational audits of Otsuka's compliance and enterprise risks, by assessing the design and operating effectiveness of internal controls (through detailed transaction testing) to identify control gaps or risks.
• Oversee, develop, and execute audit process steps, including reviewing audit documentation, designing audit testing procedures, interviewing stakeholders, reviewing and testing controls, and reviewing and documenting testing procedures and observations.
• Validate audit findings and observations with management and communicate final audit results to senior management, through presentations and written reports that address observations, risks, root cause analyses, and recommendations.
• Draft formal written audit reports or other Compliance reports that are clear, concise, and drive meaningful action to strengthen controls and mitigate compliance and enterprise risks.
• Directly manage at least one full time employee (FTE), which includes providing oversight, coaching, ensuring completion of training, and creating and managing team goals.
• Directly manage third party consultants and actively oversee audits and risk assessments conducted by third parties on Otsuka's behalf, ensuring audit quality and on-time delivery within budget.
• Manage auditing and risk assessment budget, ensuring alignment with financial goals by tracking expenses and identifying cost-saving opportunities.
• Collaborate cross-functionally with other U.S. E&C teams, including Aggregate Spend, Investigations, and Compliance Counsel and internal stakeholders on compliance matters. Establish and maintain effective relationships with internal stakeholders.
• Draft sections of reports and documents intended for submission to various organizational committees, including the Vice President & U.S. Chief Compliance Officer, OAPI/OPDC Joint Boards of Directors, and Audit Committee.
• Lead and oversee the U.S. Compliance Risk Assessment on an annual basis, working directly with senior management. Develop and recommend risk mitigation and strategies based on risk assessment outcomes. Ensure the risk assessment process and focus areas are continuously improved to reflect best practices, regulatory trends, and guidelines.
• Support Executive Director, Governance, Risk Management & Compliance and Senior Director, Healthcare Law Auditing & Monitoring with other assignments, as needed. May include domestic travel up to 25%.
• Maintain a working knowledge of relevant trends, laws and regulations pertaining to healthcare law, regulatory compliance, and auditing. Assists in developing or improving processes and procedures that promote compliance with healthcare laws, regulations, and guidance.

Qualifications
Required

• At least 10 - 12 years of experience within the pharmaceutical industry performing auditing or monitoring activities and strong understanding of enterprise risk management frameworks, internal controls, and risk assessment and audit methodologies.
• Pharmaceutical, Healthcare, or related industry experience.
• Experience with regulators, external auditors, and independent review organizations.
• Bachelor's degree in Accounting, Risk Management, or a related field.
• Certified Public Accountant (CPA), Certified Internal Auditor (CIA), Certified Information Systems Auditor (CISA) or other certification or professional designation in accounting, compliance, or auditing.

Preferred

• Experience at top tier accounting firm is preferred.

Competencies

• Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
• Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
• Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
• Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
• Respectful Collaboration - Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
• Empowered Development - Play an active role in professional development as a business imperative.

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.

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 be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request.

Statement Regarding Job Recruiting Fraud Scams
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.

Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.

To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External. Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: 800-363-5670. If you believe you are the victim of fraud resultingfrom a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: https://www.ic3.gov, or your local authorities.

Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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Posted 1/3/2025