PCF | Pharmaceutical Compliance Forum

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EMPLOYMENT OPPORTUNITIES

COMPLIANCE MANAGER, MONITORING, AUDITING & RISK - Chiesi- Cary, NC US
SENIOR MANAGER, COMPLIANCE PROGRAM EFFECTIVENESS - Insmed- Bridgewater, NJ US/Remote
SENIOR MANAGER, HEALTHCARE COMPLIANCE OFFICER - Johnson & Johnson Services Inc.- Raritan, NJ US; Horsham, PA US; New Brunswick, NJ US; Titusville, NJ US
EXECUTIVE DIRECTOR, CORPORATE COMPLIANCE BUSINESS PARTNERING - BioCryst- Remote
DIRECTOR, COMPLIANCE - BUSINESS PARTNER - Boehringer Ingelheim- Ridgefield, CT US
DIRECTOR, ETHICS & COMPLIANCE BUSINESS PARTNER - Veloxis Pharmaceuticals, Inc.- Cary, NC US / Hybrid
DIRECTOR FIELD COMPLIANCE AND INVESTIGATIONS - Lundbeck Pharmaceuticals- Deerfield, IL US
DIRECTOR, GOVERNANCE, RISK MANAGEMENT & COMPLIANCE OPERATIONAL AUDITOR - Otsuka America Pharmaceutical- Princeton, NJ US; Hybrid
STRATEGIC BUSINESS PARTNER, ETHICS AND BUSINESS INTEGRITY - Sanofi- Cambridge, MA US
STRATEGIC BUSINESS PARTNER, NORTH AMERICA AND GLOBAL SPECIALTY CARE - Sanofi- Cambridge, MA US
MANAGER, HEALTHCARE LAW AUDITING & MONITORING - Otsuka- Princeton and Rockville, MD US

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.

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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

A Certified Great Place to Work®

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.

Apply here
Posted 1/23/2025

DIRECTOR, COMPLIANCE - BUSINESS PARTNER - Boehringer Ingelheim
Location: Ridgefield, CT US

Join us on our journey at Boehringer Ingelheim https://www.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).
#LI-AP1

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Posted 1/22/2025

DIRECTOR, ETHICS & COMPLIANCE BUSINESS PARTNER - Veloxis Pharmaceuticals, Inc.
Remote Type: Hybrid
Location: Cary, NC US
Full time
Job Requisition ID: R4491

SUMMARY:
The Asahi Kasei Group operates with a commitment of creating for tomorrow. Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.

Veloxis Pharmaceuticals is an Asahi-Kasei Group Company based in Cary, NC. Our purpose is to transform transplant medicine as the primary partner to the community of transplant healthcare providers and their patients; our focus is in developing new therapies and programs to help transplant healthcare providers and the patients they treat. Veloxis provides a dynamic and innovative place to work that encourages professional development and embraces diversity. We seek creative, intelligent, action-oriented, and passionate individuals who thrive in a collaborative team environment. If you are interested in being part of a patient-centric company, then we invite you to learn more about the employment opportunities available at Veloxis. Our success is tied to the contribution of every team member, which is why we provide a valuable and competitive compensation package that includes health and insurance benefits, training, and development opportunities, as well as performance-based bonus eligibility.

Job Description:
This position contributes to the Company's success through supporting the Ethics and Compliance program in partnership with key business functions as defined below. The position is responsible for driving proactive and collaborative partnerships through consultation on applicable laws, regulations and guidance.

Summary of Key Responsibilities

Provides compliance advisory services to Commercial (Sales, Marketing, Market Access) and Medical Affairs business units (“Business Units”) in alignment with laws, regulations, the Company's Code of Conduct, polices/procedures, and the Company's Ethics and Compliance program. This includes:

Anti-bribery/anti-corruption laws (e.g., Foreign Corrupt Practices Act (FCPA))
Federal Food, Drug and Cosmetic Act (FD&C) and FDA regulations
False Claims Act (FCA), Anti-Kickback Statute (AKS)
Federal Sunshine Act and relevant state transparency/aggregate spend laws
PhRMA Code on Interactions with Health Care Professionals (HCP) guidance
OIG guidance relating to compliance programs and interactions with HCPs, and
Other relevant federal and state laws governing compliance.

Supports pull-through of Company's evolving global compliance program in accordance with the OIG 7 Elements of an Effective Compliance Program.
Identifies new and emerging risks within the Business Units' business functions and responds with a risk posture calibrated to business needs and growth imperatives.
Delivers meaningful and effective risk-based compliance training to the Business Units teams in alignment with department Compliance Plan.
Supports and pulls through the Ethics and Compliance Monitoring Program (“Monitoring Program”)), including conducting field-based employee visits (Commercial and Medical Affairs), attending live and virtual speaker programs, and other field-based interactions with HCPs as identified by the approved Monitoring Program.
Supports best practices to evolve the compliance program goals, objectives, strategy, and structure inclusive of assisting in establishing metrics and monitoring processes to demonstrate effectiveness over an expanded mandate.
Supports Compliance Operations in conducting investigations and corrective/preventative measures.
Supports the Company's Ethics and Compliance Committee on a regular basis in collaboration with the Company's Chief Ethics & Compliance Officer and the Ethics and Compliance team.
Supports the Company's' privacy program across the Business Units' business functions in partnership with the Company's Legal department.
Supports periodic internal reviews, risk assessments, monitoring, and auditing in partnership with business functions to ensure that Ethics and Compliance identifies potential compliance risks and remediates where necessary.
Participates in the periodic review and update of Compliance program policies and procedures.

Required Qualifications and Skills

BA/BS. MA/MS a plus.
Minimum of 4 years of relevant compliance experience in pharmaceuticals/biotech, preferably 6 years of compliance experience in a healthcare setting.
Experience in compliance program strategy and transformational initiatives between business units and corporate risk and compliance functions, preferred.
Ability to recognize compliance risk and develop workable strategies to mitigate such risk.
In-depth knowledge of U.S. laws, regulations, and codes relevant to job responsibilities.
Ability to collaborate with business partners, influence peers, and interact with both senior management and field-based team members.
Ability to build and maintain solid, collaborative working relationships across multiple functions and levels of management; and drive improvement initiatives with a sense of urgency.
Ability to work in a fast-paced, dynamic organization, supporting a rapidly growing business.
Exceptional relationship-building skills; must be a team player and support the Ethics and Compliance function's goal of proactive and collaborate relationships with all business functions.
Strong presentation, verbal, and written skills.
Strong computer skills, with literacy in new media, and experience integrating information and data from multiple applications. Advanced proficiency in MS Office Suite and any presentation tools.

Travel Requirements: Approximately 25-30% (national)

#LI-AS1 #Hybrid
As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.

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Posted 1/14/2025

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.

Apply here
Posted 1/3/2025

STRATEGIC BUSINESS PARTNER, ETHICS AND BUSINESS INTEGRITY - Sanofi
Location: Cambridge, MA US
Time Type: Full time
End Date: March 3, 2025 (30+ days left to apply)
Job Requisition ID: R2773524

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

This key position in Sanofi's Ethics & Business Integrity (E&BI) group serves as a Strategic Business Partner and Compliance Officer for Sanofi's North America and Global Specialty Care business. Serving as a driver of Sanofi's positive compliance culture, this position works closely with Commercial, Medical and enabling functions on various initiatives and projects and provides day-to-day advice and support on local and global E&BI matters. This position serves as colleagues' point of contact on compliance-related issues and concerns within their area of responsibility, which may include business units/areas such as Oncology, Neurology, Rare Diseases, Immunology, Research & Development and Patient Support Services. This position works collaboratively with other E&BI colleagues and members of Legal, People and Culture, Field Operations, Transparency, Finance and other functional and business areas and outside resources to support appropriate controls and risk mitigation. This position partners with their peer Strategic Business Partners to support robust governance, thoughtful risk taking and ethical practices across the company. This position routinely leads reporting to senior management at both business and E&BI-led meetings. Finally, this position exercises independent judgment in assessing compliance-related matters and supporting the business, develops and advises on any needed compliance remediation strategies, provides strategic oversight of all elements of the Company's compliance program and reports to the Global and North America Head Strategic Advisor for Specialty Care.

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

Main Responsibilities:

Provides strategic, timely and practical compliance advice and risk assessment on initiatives, projects and field and home office activities to individuals at all levels and roles in Sanofi's organization.
Partners with colleagues in North America and Global E&BI as well as other functional and business areas to implement local and global requirements, internal standards such as Sanofi's Code of Conduct, industry standards and the requirements of the company's Corporate Integrity Agreement (CIA).
Develops and delivers training on global and local healthcare requirements, guidance and updates from relevant government regulators and pertinent industry and internal standards.
Effectively communicates with Sanofi management on key risks and topics identified from Helpline inquiries, monitoring program results and daily oversight of the compliance program.
Maintains trusted relationships with leadership in Commercial, Medical and enabling functions to integrate compliance into strategic decisions.
Co-leads the necessary reporting in their areas of responsibility at meetings, including Compliance Committees, Business Updates and Town Halls.
Leads and participates in special projects, acting as a catalyst for corporate initiatives in the NA/Global E&BI Organization, such as business process improvement efforts.
Maintains strict confidentiality and discretion

About You
Required Educational Background and Job-Related Experience

Experience assessing fraud and abuse risk and problem solving in a risk-based, pragmatic way
Demonstrated ability to manage and lead change in a large, matrixed organization
Exceptional communication and relationship-management skills to enable partnership with key leaders in Commercial, Medical and enabling functions
Five years of proven experience in a strategic role in the pharmaceutical/life sciences industry preferred
B.A./B.S. degree required; advanced degree in a related field preferred
Excellent written, oral and presentation skills

Why Choose Us?

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

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

Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.

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

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

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

Apply here
Posted 12/21/2024

STRATEGIC BUSINESS PARTNER, NORTH AMERICA AND GLOBAL SPECIALTY CARE - Sanofi
Location: Cambridge, MA US

Main Responsibilities:

Provides strategic, timely and practical compliance advice and risk assessment on initiatives, projects and field and home office activities to individuals at all levels and roles in Sanofi's organization.
Partners with colleagues in North America and Global E&BI as well as other functional and business areas to implement local and global requirements, internal standards such as Sanofi's Code of Conduct, industry standards and the requirements of the company's Corporate Integrity Agreement (CIA).
Develops and delivers training on global and local healthcare requirements, guidance and updates from relevant government regulators and pertinent industry and internal standards.
Effectively communicates with Sanofi management on key risks and topics identified from Helpline inquiries, monitoring program results and daily oversight of the compliance program.
Maintains trusted relationships with leadership in Commercial, Medical and enabling functions to integrate compliance into strategic decisions.
Co-leads the necessary reporting in their areas of responsibility at meetings, including Compliance Committees, Business Updates and Town Halls.
Leads and participates in special projects, acting as a catalyst for corporate initiatives in the NA/Global E&BI Organization, such as business process improvement efforts.
Maintains strict confidentiality and discretion

About You
Required Educational Background and Job-Related Experience

Experience assessing fraud and abuse risk and problem solving in a risk-based, pragmatic way
Demonstrated ability to manage and lead change in a large, matrixed organization
Exceptional communication and relationship-management skills to enable partnership with key leaders in Commercial, Medical and enabling functions
Five years of proven experience in a strategic role in the pharmaceutical/life sciences industry preferred
B.A./B.S. degree required; advanced degree in a related field preferred
Excellent written, oral and presentation skills

Why Choose Us?

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

Apply here
Posted 12/21/2024

MANAGER, HEALTHCARE LAW AUDITING & MONITORING - Otsuka
Locations: Princeton and Rockville, MD US
Time type: Full time
Posted: 30+ Days Ago
Job requisition id: R7961

Job Summary This position assists U.S. E&C's Governance, Risk Management, and Compliance (GRC) function supporting the Chief Compliance Officer in executing an effective compliance program. The Manager, Healthcare Law Auditing & Monitoring, executes the annual plan by conducting quarterly transactional analyses and live monitoring and may perform operational audits, and complete other auditing and monitoring assessments of promotional and non-promotional activities.

Job Description

Lead quarterly transactional analyses of data related, but not limited to emails, expenses, call notes, speaker programs, and HCP spend to help to ensure compliance with healthcare laws, regulations and guidance (such as the Anti-Kickback Statute, False Claims Act, OIG Guidance for Pharmaceutical Manufacturers, PhRMA Code, FDCA and PDMA)
Execute audits of processes and/or functions related to promotional and non-promotional activities, including, but not limited to, promotional materials, prescription drug samples, clinical trials, publications, and pricing agreements. Perform steps in the audit process including interviewing stakeholders, testing controls, communicating findings to stakeholders, drafting reports, and tracking corrective actions.
Assist with conducting the annual U.S. Compliance Risk Assessment, including conducting interviews and drafting reports.
Analyze and monitor compliance data and metrics to identify trends and assess the effectiveness and efficiency of monitoring activities and implement corrective actions, as needed. Contribute to continuous improvement of the U.S. E&C Compliance analytics platform.
Prepare reports that summarize areas of non-compliance and risks identified through HLAM monitoring activities.
Lead other ad-hoc reviews, inquiries, and investigations as required.
Collaborate cross-functionally with other U.S. E&C teams, including Aggregate Spend, Investigations, and Compliance Counsel.
Perform live monitoring (as needed) with domestic travel up to 25%.
Establish and maintain effective relationships with GRC, Legal Affairs, and other internal stakeholders and collaborate with them on compliance matters.
Possess and maintain an up-to-date knowledge and understanding of federal and state laws and regulations, industry codes of conduct and developments, and best practices applicable to the company's policies, practices or operations, including but not limited to the Sunshine Act, the OIG Compliance Program Guidance for Pharmaceutical Manufacturers, PhRMA Code on Interactions with Healthcare Providers, PDMA, AMA, and industry guidance documents, regulations regarding the promotion of marketed products, clinical trial regulations, and the False Claims Act and anti-kickback statutes.
Support Associate Director, Healthcare Law Auditing & Monitoring with other assignments as needed.

Qualifications/ Required
Knowledge/ Experience and Skills:

Lead by proactively taking ownership of tasks and projects and effectively communicating results to internal partners on compliance matters.
Strong organizational skills and the ability to effectively execute responsibilities independently with minimal oversight.
Able to work independently as an individual contributor and in a team setting.
Experience with data analysis, including ability to work with large amounts of data and organize results in a meaningful way to identify trends and potential red flags.
Strong verbal and written communications skills to communicate effectively with individuals up, down, and across the organization.
Strong interpersonal and project management skills.
Analytical thinker with strong conceptual and problem-solving skills.
Quick learner with the ability to analyze and identify new and emerging risks.
Bachelor's degree in a related field.
6+ years monitoring or auditing experience.in the pharma, healthcare of life science industry.
Understanding of healthcare laws and regulations and sales and marketing activities
CIA, CPA, or other certification in accounting, compliance, or auditing

Equal Opportunity Employer
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.

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.

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.

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 resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center, 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.

Apply here
Posted 12/18/2024

The Pharmaceutical Compliance Forum

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