PCF | Pharmaceutical Compliance Forum

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EMPLOYMENT OPPORTUNITIES

ASSOCIATE DIRECTOR OF COMPLIANCE TRAINING, MONITORING AND INVESTIGATIONS - Intra-Cellular Therapies- hybrid Headquarters based position, Bedminster, NJ US
DIRECTOR, COMPLIANCE AND ETHICS ORGANIZATION - MEDICAL - Bristol Myers Squibb- Princeton, NJ US (Note: eligible for a hybrid work model with at least 50% onsite at assigned facility)
ASSOCIATE DIRECTOR, COMPLIANCE AND ETHICS ORGANIZATION - WORLDWIDE MEDICAL, R&D AND GLOBAL DRUG DEVELOPMENT - Bristol Myers Squibb- Princeton, NJ US (Note: eligible for a hybrid work model with at least 50% onsite at assigned facility)
ASSOCIATE DIRECTOR, HEALTHCARE COMPLIANCE - Immunocore- Gaithersburg, MD US, Conshohocken, PA US
US INTEGRITY & COMPLIANCE AUDITING LEAD - Indivior- Hybrid position in Richmond, VA US
SENIOR MANAGER, CORPORATE COMPLIANCE - Crinetics Pharmaceuticals, INC.- San Diego, CA US
SENIOR DIRECTOR, OF GLOBAL TRANSPARENCY AND COMPLIANCE ASSURANCE - Madrigal Pharmaceuticals- West Conshohocken, PA US
ASSOCIATE DIRECTOR - LEAD E&C TRANSPARENCY OPERATIONS - Takeda- Hybrid, Lexington, MA US
ASSOCIATE DIRECTOR, COMPLIANCE - Kiniksa Pharmaceuticals- Hybrid, Lexington, MA US
HEAD OF ETHICS & BUSINESS INTEGRITY GOVERNANCE, OPERATIONS AND RISK MANAGEMENT - NORTH AMERICA AND GLOBAL SPECIALTY CARE - Sanofi- US / Cambridge (U.S.) / Cambridge Crossing / 450 Water Street - Office Building
SR. COMPLIANCE AND ETHICS SPECIALIST - Neurocrine Biosciences- (min 40% travel) San Diego based US
COMPLIANCE COUNSEL - Neurocrine Biosciences- San Diego based USA
US INTEGRITY & COMPLIANCE OFFICER - Indivior- Richmond, VA US / Hybrid

ASSOCIATE DIRECTOR OF COMPLIANCE TRAINING, MONITORING AND INVESTIGATIONS - Intra-Cellular Therapies
Location: This is a hybrid Headquarters based position. There is an expectation that the candidate will be in the Bedminster, NJ office on Tuesday and Wednesday weekly.
Benefits Offered: 401K, Dental, Life, Medical, Vision
Employment Type: Full-Time

"We deliver innovative treatments to improve the lives of individuals suffering from neuropsychiatric, neurologic and other disorders"

Intra-Cellular Therapies is a biopharmaceutical company committed to the development of novel CNS drugs, leveraging innovative technology based on the pioneering efforts of ITCI co-founder and Nobel laureate, Dr. Paul Greengard. ITCI has a diverse portfolio of approved and investigational compounds across different stages of clinical development. Our lead candidate, lumateperone (CAPLYTA®), is FDA-approved for the treatment of schizophrenia in adults as well as for the treatment of bipolar depression in adults as monotherapy and as adjunctive therapy.

The Associate Director of Compliance Training, Monitoring and Investigations will report to the Executive Director in Compliance and will be primarily responsible for all aspects of training, monitoring, auditing and Compliance investigations. The Associate Director will collaborate with other members of the Compliance team on continuous improvement to all Seven Elements of an effective Compliance Program to comply with Federal and State requirements.

Responsibilities:

Oversee the implementation of the Compliance Department's Training, Monitoring, Auditing and Investigations
Compliance Monitoring and Auditing:

Manage third-party monitor
Develop and maintain annual monitoring plan
Conduct and oversee the monitoring of:

Speaker Programs
Meals with HCPs
Consulting and Ad Board arrangements with HCPs
Live Field Ride Alongs and Speaker Program observations
Email and other documentation review for compliance with policies and procedures

Provide oversight, direction, and collaboration of external compliance field monitors.
Identify trends and gaps for continuous improvement and discipline.
Conduct audits of third parties for compliance with speaker programs, consulting, advisory board policies and transparency requirements.

Training and Education: responsible for developing and maintaining the Compliance training plan and training content. Develop, implement, and execute all aspects of the compliance training and design. Partner with Sales Training and the LMS Training Department to ensure appropriate and effective training and education across the organization.
Investigations: Conduct internal compliance investigations and collaborate with HR, outside counsel, and other internal stakeholders to coordinate investigations. Participate in Outcome Committee meetings regarding employee coaching and discipline. Deliver Coaching and Discipline.
The Associate Director will collaborate with other members of the Compliance team on continuous improvement to all Seven Elements of an effective Compliance Program to comply with Federal and State requirements.

Requirements:

College Degree required from an accredited college or university
8-12 years of compliance, training, monitoring, auditing, and investigations within the pharmaceutical or life sciences industry
Knowledge of the legal and regulatory environment within the pharmaceutical or life sciences industry
Working experience managing vendors and consultants and keep each accountable to task and budget
Ability to successfully work and partner with internal cross-functional teams
Strong verbal and written communication skills
Understanding of LMS and training systems
Ability to prioritize and work on multiple projects and strong attention to detail
Must be able to perform all essential functions of the position, with or without reasonable accommodation

Intra-Cellular Therapies is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status, disability or any other legally protected status.

Associate Director, Compliance Training, Monitoring, and Investigations Base Salary Range $130,000 - $165,000

Apply here
Posted 10/17/2024

DIRECTOR, COMPLIANCE AND ETHICS ORGANIZATION - MEDICAL - Bristol Myers Squibb
Location: Princeton, NJ US (Note: eligible for a hybrid work model with at least 50% onsite at assigned facility)

Job Description:

Working with Us
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

Position Summary:
Reporting to the Head of US and Above Market Compliance and Ethics Organization, this role partners with senior leaders across Legal, Commercial, Medical, R&D, Global Drug Development, Regulatory, IT, Audit, Finance and HR to build and integrate one global compliance program into the US Medical Organization. In this role, you will combine your knowledge about risk mitigation strategies, such as education and monitoring, with data analytics about executional risk to help the business make well-informed, risk-based decisions. You will help operationalize those decisions by crafting simple, clear, principle-based policies. You will educate the business about those policies – and why they exist – leveraging adult-learning techniques that aid retention. And you will use a combination of live monitoring, transactional monitoring, and data analytics to monitor the business's adherence to those policies, helping the business remediate deviations from policies by identifying and addressing the root causes of those deviations. The ideal candidate will be able to execute these tasks with a mindset that believes business functions and Compliance and Ethics are equally accountable for both company success and ethical behavior and will be recognized internally and externally as an expert in mitigating healthcare compliance risk through providing advice, drafting policy, providing education and monitoring execution of high-risk activities.

Responsibilities Include:

Develop and conduct risk assessments utilizing a combination of data analytics, external and internal benchmarking, and review of enforcement trends, to proactively identify the most pressing areas of risk.
Foster trusting relationship with business leaders that enable you to learn of – and advise on – executional risk associated with new initiatives and counsel business leaders about educational initiatives, new policies or monitoring capabilities that can help mitigate risk associated with their decisions.
Analyze data regarding execution of analogous activities to better inform business leaders of the risk associated with their decisions.
Draft simple, easy to understand policies that empower the business to execute activities in an ethical and efficient way.
Develop and provide training that utilizes adult-learning principles, such as gaming, microlearning, and experiential learning, to enhance retention of compliance messages.
Establish a network of Compliance Champions in the respective business unit to integrate compliance messaging and concepts into established business training cycles.
Conduct live and transactional monitoring of business activities.
Determine and allocate budget for training and culture initiatives for specific therapeutic areas.
Identify and leverage key stakeholders and cross-functional resources to create buy-in for training and cultural initiatives for specific therapeutic areas.
Review data to identify outliers and implement preventive education or additional monitoring in response.
Perform other compliance-related activities as directed by the Global Compliance & Ethics team and/or the Head of US and Above Market Compliance.

Qualifications:

Bachelor's degree.
Advanced degree (MBA, CPA, JD) appreciated but not required.
12-15 years pharmaceutical or healthcare related compliance or legal experience, with at least 5 years experience counseling clients.
Working knowledge of relevant US pharmaceutical compliance guidelines, regulations (AKS, FCA, FDCA, HIPAA, FCPA) and PhRMA Code principles.
Familiarity with practices of and intersections between commercial sales, marketing, medical affairs, and market access organizations in the pharmaceutical industry.
Ability to work and communicate with senior level executives with an enterprise mindset focused on achieving company goals in a compliant and ethical manner.
Demonstrated ability to influence business decisions.
Comfort with using data to tell stories particularly around risk and effectiveness of risk mitigation strategies.
Entrepreneurial spirit, taking ownership over the risks and processes you identify and searching for creative solutions.
Proven experience drafting principle-based policies.
Experience utilizing adult-learning concepts in corporate educational and training materials.
Experience conducting live monitoring of speaker programs and advisory boards, and transactional monitoring of engagements with health care providers.
Commitment to a diverse and inclusive workplace.

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as "Transforming patients' lives through science™ ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Apply here
Posted 10/4/2024

ASSOCIATE DIRECTOR, COMPLIANCE AND ETHICS ORGANIZATION - WORLDWIDE MEDICAL, R&D AND GLOBAL DRUG DEVELOPMENT - Bristol Myers Squibb
Location: Princeton, NJ US (Note: eligible for a hybrid work model with at least 50% onsite at assigned facility)

Position Summary:
Reporting to the Senior Director, US and Above Market Medical and Market Access C&E Lead, this role partners with senior leaders across Legal, Commercial, Medical, R&D, Global Drug Development, Regulatory, IT, Audit, Finance and HR to build and integrate one global compliance program into the Worldwide Medical, R&D and Global Drug Development Organizations. In this role, you will combine your knowledge about risk mitigation strategies, such as education and monitoring, with data analytics about executional risk to help the business make well-informed, risk-based decisions. You will help operationalize those decisions by crafting simple, clear, principle-based policies. You will educate the business about those policies - and why they exist - leveraging adult-learning techniques that aid retention. And you will use a combination of live monitoring, transactional monitoring, and data analytics to monitor the business's adherence to those policies, helping the business remediate deviations from policies by identifying and addressing the root causes of those deviations. The ideal candidate will be able to execute these tasks with a mindset that believes business functions and Compliance and Ethics are equally accountable for both company success and ethical behavior and will be recognized internally and externally as an expert in mitigating healthcare compliance risk through providing advice, drafting policy, providing education and monitoring execution of high-risk activities.

Responsibilities Include:

Conduct risk assessments specific to medical affairs and clinical trial/research activities, utilizing a combination of data analytics, external and internal benchmarking, and review of enforcement trends, to proactively identify the most pressing areas of risk.
Foster trusting relationship with business leaders that enable you to learn of - and advise on - executional risk associated with new initiatives and counsel business leaders about educational initiatives, new policies or monitoring capabilities that can help mitigate risk associated with their decisions.
Analyze data regarding execution of analogous activities to better inform business leaders of the risk associated with their decisions.
Under the direction of the Senior Director, US and Above Market Medical and Market Access C&E Lead, draft simple, easy to understand policies specific to medical affairs and clinical trial/research activities that empower the business to execute activities in an ethical and efficient way.
Under the direction of the Senior Director, US and Above Market Medical and Market Access C&E Lead, develop and provide training specific to medical affairs and clinical trial/research activities that utilizes adult-learning principles, such as gaming, microlearning, and experiential learning, to enhance retention of compliance messages.
Establish a network of Compliance Champions in the respective business unit to integrate compliance messaging and concepts into established business training cycles.
Develop a framework for conducting live and transactional monitoring of medical affairs and clinical trial/research activities.
Review data to identify outliers and implement preventive education or additional monitoring in response.
Perform other compliance-related activities as directed by the Global Compliance & Ethics team and/or the Head of US and Above Market Compliance.

Qualifications:

Bachelor's degree.
Advanced degree (MBA, CPA, JD) appreciated but not required.
8-12 years pharmaceutical or healthcare related compliance or legal experience.
Working knowledge of relevant pharmaceutical compliance guidelines, regulations (AKS, FCA, FDCA, HIPAA, FCPA) and PhRMA Code principles.
Familiarity with healthcare compliance risks associated with clinical trial placement and recruitment, advisory boards, medical congresses and other research and development or medical affairs activities.
Familiarity with practices of and intersections between commercial sales, marketing, and medical affairs organizations in the pharmaceutical industry a plus.
Ability to work and communicate with senior level executives with an enterprise mindset focused on achieving company goals in a compliant and ethical manner.
Demonstrated ability to influence business decisions.
Comfort with using data to tell stories particularly around risk and effectiveness of risk mitigation strategies.
Entrepreneurial spirit, taking ownership over the risks and processes you identify and searching for creative solutions.
Proven experience drafting principle-based policies.
Experience utilizing adult-learning concepts in corporate educational and training materials.
Experience conducting live monitoring of speaker programs and advisory boards, and transactional monitoring of engagements with health care providers.
Commitment to a diverse and inclusive workplace.

Apply here
Posted 10/4/2024

ASSOCIATE DIRECTOR, HEALTHCARE COMPLIANCE - Immunocore
Location: Gaithersburg, MD US, Conshohocken, PA US
Vacancy No: VN497
Employment Type: Full Time
Department: Legal

MAIN PURPOSE OF JOB
Reporting to the Vice President, Compliance, the Associate Director, Compliance will serve an important role in Immunocore's continued enhancement of its Compliance program. This position will provide a broad range of compliance support and work to assist in the implementation, maintenance, and continued improvement of Immunocore's compliant and ethical practices and behaviors through close collaboration with internal and external business partners.

The incumbent is expected to be recognized as an emerging expert, advisor, and subject matter expert across the company in the field of healthcare compliance and to be able to interpret internal or external business challenges and recommending best practices or identifying new solutions.

The Associate Director, Compliance will also have primary responsibility for executing key elements of Immunocore's U.S. Compliance program and ensuring compliance with all applicable laws and guidance.

KEY RESPONSIBILITIES
General

Help identify new work processes, tools or resources that will have broad applicability throughout the organization and assist with the implementation of Compliance systems and processes
Provide training to internal and external organizational clients on a broad range of topics including anti-bribery, FDA regulations, transparency reporting and company policies
Assist in the development and maintenance of relevant Standard Operating Procedures, work instructions, and guidance documents related to key areas within Compliance

Transparency Reporting

Oversee data collection and generation of US and global transparency reports and subsequent reporting of transparency reports to applicable authorities
Maintains understanding of disclosure laws, regulations and applicable industry codes

Auditing & Monitoring

Perform auditing and monitoring of Medical and Commercial activities to ensure compliance with applicable laws, regulations and company policies
Review of Medical and Commercial documentation to ensure compliance with company SOPs and policies
Partner with cross-functional colleagues to address detected noncompliance, including corrective actions when needed

PERSON SPECIFICATION
Experience & knowledge
Essential

Knowledge of and experience with laws, regulations, and industry guidance that affect the pharmaceutical industry including global aggregate spend and other reporting/sunshine laws, fraud and abuse and anti-kickback statutes, OIG and PhRMA guidelines, and state marketing and price reporting compliance laws
Experience with US and global transparency reporting
Experience developing and executing audits and monitoring
Strong operational and project management skills required
Excellent organization, communication and presentation skills. Candidate must have strong team orientation and problem-solving skills
Candidate must be able to work independently and prioritize multiple demands

Desirable

Experience with creating and delivering compliance training for field team and home office colleagues
Experience with participating in compliance investigations

KEY BEHAVIOURAL ATTRIBUTES

Openness and honesty
Readily offering information pertaining to work in hand whether positive or negative.
Taking responsibility
Being prepared to accept full responsibility for tasks entrusted to them; seeing tasks through to completion and dealing with the consequences of failure or success.
Flexibility
Being flexible to new ideas and approaches; changes of plans, objectives and/or priorities. Handling disjointed tasks effectively.
Team spirit
Being able to work productively with others to achieve tasks. Showing consideration for the needs and feelings of others.

SPECIFIC BEHAVIOURAL ATTRIBUTES

Attention to Communication: Ensuring information and work is passed on correctly and in a timely way to those who depend on it.
Written & Oral Communication: Writing and speaking clearly to share thoughts and information concisely and appropriately.
Diagnostic Information Gathering: Identifying the information required to clarify a situation, asking questions when required.
Results Orientated: Focusing on desired results, seeking help and support to overcome obstacles in a timely manner.
Thoroughness: Ensuring work and information provided is complete, carefully checking and seeking additional support to help achieve this if needed.
Managing Self Performance: Works to specific and measurable goals, seeking support and advice when dealing with unfamiliar or new issues.
Analytical Thinking: Tackling day –to-day problems using a logical and systematic approach, identifying discrepancies and inconsistencies.

Education & qualifications

Requires a B.A./B.S. degree or equivalent (Advanced degree preferred) with 7+ years in compliance, audit and/or other related experience required. Pharmaceutical experience required
Certified in Healthcare Compliance (CHC) a plus

Other

This position requires 25% travel
This role is based in our Conshohocken, PA office. Our office-based employees follow a hybrid schedule of 4-5 days in the office.

About the Company:
Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry's most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions.

Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases.

At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients' lives, advancing medicine, and supporting one another in these pursuits.

Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law.

Apply here
Posted 9/26/2024

US INTEGRITY & COMPLIANCE AUDITING LEAD - Indivior
Location: Richmond, VA (Relocation assistance provided for non-local candidates)
Richmond based hybrid position (Tues-Thurs in office)
Full time
Reports To: US Integrity & Compliance Officer
Job requisition id: R2477

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

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

POSITION SUMMARY:
The Integrity & Compliance (I&C) Auditing Lead is tasked with enhancing and implementing Indivior's Healthcare Compliance Auditing program. This includes leveraging analytical approaches and technology to improve the program's effectiveness and efficiency, leading continuous improvement projects, and supervising the I&C auditing activities of third-party consultants.

ESSENTIAL FUNCTIONS:
The responsibilities of this role include, but are not limited to, the following:

Develop and enhance Healthcare Compliance Auditing protocols, procedures, and training materials.
Support annual Healthcare Compliance Risk Assessment & Mitigation Planning activities and develop risk-based auditing plans.
Conduct audits and monitoring activities to ensure compliance with Indivior requirements, as well as those required by Indivior's Corporate Integrity Agreement (CIA).
Develop Auditing testing criteria, analyze information, and identify and document observations and recommendations.
Identify and implement continuous control monitoring opportunities.
Enhance and maintain Audit dashboards and reporting tools.
Collaborate with Internal Audit and Quality Audit functions and support external inquiries and audits.
Develop and deliver training on A&M topics.
Oversee A&M activities and consultants.
Complete in-person field observations with Indivior commercial and medical field-based workforce.

MINIMUM QUALIFICATIONS:

Education: Bachelors required, Graduate Degree preferred.
Experience: 3-5 years of compliance risk management and auditing experience for a US life sciences company, accounting firm (e.g., forensic accounting), or healthcare consulting firm. Additional experience in commercial roles is valued, but not required.
Preferred: Experience in Healthcare Compliance and implementing corporate integrity agreements.
Travel: 30-40% as needed.

COMPETENCIES/CONDUCT:
In addition to the minimum qualifications, the employee will demonstrate:

Strong project management, problem-solving, and critical thinking skills.
Effective communication and interpersonal skills, with the ability to influence and drive change.
Knowledge of pharmaceutical compliance regulations and government (e.g., FDA, OIG HHS) guidance affecting the pharmaceutical industry.
Proficiency in data analytics software and power apps (e.g., PowerBI) and experience with report-building software (e.g., Tableau).

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

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

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

COMPLIANCE OBLIGATIONS:
Indivior is committed to maintaining a workplace where employees are committed to compliance and feel comfortable raising concerns about potential violations of policies or unethical behaviour. As part of your responsibilities, you are expected to:

Employee Obligations:

Always act with honesty and integrity.
Risk IQ: Know what policies apply to your role and function and adhere to them.
Speak Up: If you see something, say something.

Manager Obligations:

Always act with honesty and integrity
Reinforce risk awareness with your team, with accountability and oversight for ongoing review and mitigation.
Model and reinforce a Speak Up culture on your team.

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

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

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Posted 8/21/2024

SENIOR MANAGER, CORPORATE COMPLIANCE - Crinetics Pharmaceuticals, INC.
LOCATION: San Diego, CA US
REPORTS TO: Director, Corporate Compliance
FLSA: Exempt
DEPARTMENT: Legal
GxP Related Y/N: N

Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. This is an exciting time to join Crinetics as we shape our organization into the world's premier fully integrated endocrine company from discovery to patients. Join our team as we transform the lives of others.

Position Summary:
The Senior Manager, Corporate Compliance is responsible for assisting the Compliance department in developing, implementing, and maintaining an effective Corporate Compliance program that supports and promotes a company-wide culture of ethics and compliance while ensuring all legal, regulatory, and ethical obligations of a pharmaceutical company are being upheld. The position will assist in executing the elements of Crinetics' compliance program, with an emphasis on auditing and monitoring of business activities, the management of transparency reporting (federal and state), and the annual compliance risk assessment.

Essential Job Functions and Responsibilities:
These may include but are not limited to:

Collaborate with Compliance leadership and other cross-functional leaders to help support all aspects of the annual Compliance risk assessment.
Assist in the development and execution of the annual Auditing & Monitoring plan.
Objectively and independently conduct compliance audit reviews of business processes and activities to identify potential risks, assess internal controls, and evaluate the overall effectiveness of the Compliance program.
Manage the third-party vendor day-to-day live monitoring activities and provide recommendations for remediation on all findings.
Draft remediation plans and timelines and oversees the completion of agreed-upon remediation by assigned business owners.
Partner with third-party vendor to manage and execute against all Federal and State reporting requirements, including Aggregate Spend reporting (i.e. Physician Payment Sunshine Act)
Maintain an up-to-date knowledge and understanding of federal and state laws and regulations, industry codes of conduct applicable to the Company's policies, practices and operations, including but not limited to the OIG Compliance Program Guidance for Pharmaceutical Manufacturers, PhRMA Code on Interactions with Healthcare Providers, regulations regarding the promotion of marketed products, clinical trial regulations and the False Claims Act and Anti-Kickback statute.
Other duties as assigned.

Education and Experience:

Bachelor's degree (advanced degree such as master's degree preferred) with at least 12 years of compliance related experience
Certification of Healthcare Compliance (CHC) and/or Certified Compliance and Ethics Professional (CCEP) preferred
Previous experience in a compliance role including the day-to-day management and execution of an auditing and monitoring program, and the management of all federal and state reporting requirements
Demonstrated ability to work collaboratively across multiple departments with strong interpersonal and communication skills
Ability to interact and present to various internal stakeholders
Ability to successfully manage, synthesize and communicate complex information in an effective manner
Ability to work independently, identify opportunities, explore options and recommend solutions through strong critical thinking, problem solving and decision-making skills
Experience with change management working in a high growth environment preferred

Physical Demands and Work Environment:
Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.

Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply.

Travel:
You may be required to travel for quarterly on-site meetings and up to an additional 5% of your time.

The Anticipated Base Salary Range: $111,000-$148,000
In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.

The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process.

Equal Opportunity Employer:
Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.

Vaccination requirement:
Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, Crinetics requires that all employees and contractors be fully vaccinated and have received the COVID-19 vaccines as a condition of employment. "Full vaccination" is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.

The above statements are intended to describe the general nature and level of work being performed. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified. They are representative of those knowledge, skills, and abilities that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform essential functions.

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Posted 8/21/2024

SENIOR DIRECTOR, OF GLOBAL TRANSPARENCY AND COMPLIANCE ASSURANCE - Madrigal Pharmaceuticals
Location: West Conshohocken, PA US

The Senior Director, of Global Transparency and Compliance Assurance is responsible for assisting the Compliance Officers and the Chief Compliance Officer with the implementation and management of Madrigal's Compliance Program. This includes supporting efforts to continuously enhance Madrigal's Compliance program based on the legal enforcement environment in the U.S. through the application of best practices in the life sciences Compliance space. This role requires significant experience with building and managing Compliance programs such as Transparency reporting infrastructure, Investigations and Monitoring programs. This role requires interaction with other members of the Compliance and Legal teams as well as Sales and Marketing, Information Technology, Finance, Market Access, Medical Affairs, R&D and other functions.

Position Responsibilities:

Work with other members of the Compliance and Legal team to maintain and enhance the infrastructure for the U.S. business that supports a company culture of compliance and recognizes that compliance is a collective responsibility of all company employees
Develop tools, processes and reports to support the U.S. business's ownership of Compliance
Participate in routine meetings with U.S. business partners
Create and deliver function-specific trainings and communications
Assist with evaluating and remediating monitoring and investigation findings
Assist with conducting annual compliance risk assessments, including evaluating results and identifying areas of improvement
Conduct field monitoring activities and other office-based auditing/monitoring
Provide guidance to the U.S. Business and integrate compliance controls into the scope of existing business practices where applicable
Maintain a current working knowledge of various laws, regulations, and industry guidance that affect the corporate-wide compliance program, including federal and state transparency requirements, state and federal privacy laws, OIG and DOJ guidelines, PhRMA code and state marketing compliance laws
Support Investigations and Monitoring program as needed
Other duties and special projects as assigned

Qualifications and Skills

Bachelor's degree required; advanced degree (JD or CPA) and/or people management experience preferred
Minimum of 10 years of pharmaceutical/life sciences compliance experience
Proven record of accomplishment in the areas of U.S. compliance best practices
Knowledge of and experience with laws, regulations, and industry guidance that affect the pharmaceutical industry
Ability to communicate effectively in both verbal and written form with multiple stakeholders within and outside the company
Ability to collaborate and work effectively with cross-functional teams and projects
Strategic leadership capability, strong organizational awareness, sound judgment, strong business acumen and ability to make decisions with the input of appropriate input from multiple stakeholders
Strong problem solving and risk analysis skills
Ability to effectively prioritize and work in a fast-paced environment and to handle multiple complex and confidential tasks
Position is designated as remote; however, 25% travel is required and ability in particular to readily access office locations in either Conshohocken, PA and/or Waltham, MA

Compensation:
Base salary is determined by several factors that include, but are not limited to, a successful candidate's qualifications, skills, education, experience, business needs, and market demands. The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance.

Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.

Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established.

Please be aware that we are currently receiving numerous reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals' Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigal's name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process. Interviews with Madrigal are conducted via the Zoom platform.

Please also note that any correspondence with regard to employment would come from an authorized madrigalpharma.com email address or from an email address from one of our trusted search firm partners. We are aware that incorrect/fraudulent email addresses, with Madrigal misspelled, have been utilized in these most recent fraud attempts. If you receive unsolicited employment offers from people claiming to work for Madrigal we recommend that you: do not respond to their questions; do not open any attachments; and do not click on any hyperlinks.

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Posted 8/15/2024

ASSOCIATE DIRECTOR - LEAD E&C TRANSPARENCY OPERATIONS - Takeda
Location: Hybrid, Lexington, MA US

OBJECTIVES/PURPOSE

Ethical behaviour plays a fundamental role in risk mitigation
Being a forward-thinking leader in risk identification and mitigation
Building a modern function supporting achievement of Takeda's Vision 2025

E&C will respond rapidly to changing environment and business needs, it is close to the market, and encourages ethical behaviour in line with Takeda's values. By working in an agile manner E&C ensures the balance between stable structures, governance, processes and systems, and dynamic approaches to delivering innovative solutions to appropriately manage our risks.

E&C commits to

Act as role model for Takeda's values, ethics and values-based decision making, fostering this mindset in clients, partners and team
Enable the organization to take decisions which are ethical and in line with our priorities of Patient, Trust, Reputation, and Business
Collaborate across all E&C teams and partner with stakeholders in BU / BF to embed ethics and compliance as part of the way everyone works at Takeda

RESPONSIBILITIES

Transparency

Lead USBU Ethics & Compliance (E&C) efforts to manage and enhance the US Transparency Operations capability
Act as the business owner of the Transparency system; serve as primary liaison with the system vendor and Takeda IT support team
Program manage issues, exceptions data remediation and system enhancement requests
Lead data collection efforts for Federal and State Transparency reports as well as State Sales Rep and Marketing Disclosure Reports (Nevada, Washington DC, etc.)
Prepare, confirm and submit all required State and Federal Transparency-related Reports / Disclosures and FDA Samples report
Monitor for Federal and State transparency-related limits, caps, and restrictions
Create a cadence for performing monitoring, remediation and analytics (daily, weekly, monthly, etc.)
Manage the development and implementation of business processes, data taxonomy, and data collection designs and methods that will enable Takeda to support current and future Federal and State disclosure reporting requirements
Communicate transparency-initiative status, progress, and data analytics on a regular basis to stakeholders both across the US region and the company
Develop data analysis and monitoring mechanisms to test, validate, trend, and understand transparency data
Train and manage internal and external users of the Transparency system, including management of third-party vendors who submit data feeds
Collaborate cross functionally within the USBU, across the US region and across the company regarding the Transparency program, requirements as well as process improvement areas identified through monitoring, execution and analytics
Manage the Transparency operations team members

CAPABILITIES

Extensive knowledge of Federal and State Transparency Laws and related restrictions
Ability to work with data, databases and reporting platforms
Proficient in PowerBI or Tableau, Excel, and PowerPoint
Excellent written/verbal communication, analytical and presentation skills
Capability to lead and facilitate discussions with senior leaders within a business unit
Demonstrated ability to work cross-functionally in a highly matrixed environment
Consistently demonstrates the ability to deliver results
Able to work and deliver on deadlines while managing multiple projects and priorities effectively
Ability to rapidly assimilate to new functional scope responsibilities
Strong customer-service skills while interacting with all levels of management, field sales, marketing, marketing and sales vendors and partners
Understanding of how to translate transparency data into insights, actionable process, policy, SOP, and/or system improvements

EXPERIENCE

8+ years of legal, compliance or commercial experience, of which at least 5 years in the healthcare or pharmaceutical industry in a U.S. Transparency-related role
Experience leading teams and managing vendors
Proven ability to work successfully with others and collaborate with cross functional areas to identify needs, provide guidance, and communicate solutions
Bachelor's degree required
Experience with laws, regulations and industry guidance that affect the pharmaceutical industry including, but not limited to, OIG and PhRMA guidelines, healthcare standard operating procedures, anti-bribery laws

What Takeda can offer you:

Comprehensive Healthcare: Medical, Dental, and Vision
Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
Health & Wellness programs including onsite flu shots and health screenings
Generous time off for vacation and the option to purchase additional vacation days
Community Outreach Programs and company match of charitable contributions
Family Planning Support
Flexible Ways of Working
Tuition reimbursement

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

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

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

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

For Location: Lexington, MA
U.S. Base Salary Range: $149,100.00 - $234,300.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.?The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

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

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

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Posted 8/9/2024

ASSOCIATE DIRECTOR, COMPLIANCE - Kiniksa Pharmaceuticals
Location: Hybrid, Lexington, MA US

About the job
Reporting to the Senior Director, Compliance, the Associate Director, Compliance will serve an important role in Kiniksa's continued enhancement of its Compliance program. This position will provide a broad range of compliance support and work to assist in the implementation, maintenance, and continued improvement of Kiniksa's compliant and ethical practices and behaviors through close collaboration with internal and external business partners. The Associate Director, Compliance will also have primary responsibility for executing key elements of Kiniksa's auditing and monitoring program and ensuring compliance with US and global transparency requirements.

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

Responsibilities (including, but not limited to):

General

Help identify new work processes, tools or resources that will have broad applicability throughout the organization and assist with the implementation of Compliance systems and processes
Provide training to internal and external organizational clients on a broad range of topics including anti-bribery, FDA regulations, transparency reporting and company policies
Assist in the development and maintenance of relevant Standard Operating Procedures, work instructions, and guidance documents related to key areas within Compliance

Transparency Reporting

Oversee data collection and generation of US and global transparency reports and subsequent reporting of transparency reports to applicable authorities
Maintains understanding of disclosure laws, regulations and applicable industry codes

Auditing & Monitoring

Perform auditing and monitoring of Medical and Commercial activities to ensure compliance with applicable laws, regulations and company policies
Review of Medical and Commercial documentation to ensure compliance with company SOPs and policies
Partner with cross-functional colleagues to address detected noncompliance, including corrective actions when needed

Qualifications:

Requires a B.A./B.S. degree or equivalent (Advanced degree preferred) with 7+ years in compliance, audit and/or other related experience required. Pharmaceutical experience required
Certified in Healthcare Compliance (CHC) or Project Management Professional (PMP) a plus
Knowledge of and experience with laws, regulations, and industry guidance that affect the pharmaceutical industry including global aggregate spend and other reporting/sunshine laws, fraud and abuse and anti-kickback statutes, OIG and PhRMA guidelines, and state marketing and price reporting compliance laws
Experience with US and global transparency reporting
Experience developing and executing audits and monitoring
Strong operational and project management skills required
Excellent organization, communication and presentation skills. Candidate must have strong team orientation and problem-solving skills
Candidate must be able to work independently and prioritize multiple demands
This position requires 35-40% travel
Salary is commensurate with experience
Kiniksa Benefits Summary - USA

All Kiniksa new hires whose roles require them to enter Kiniksa's physical offices will be required to provide documentation that they are fully vaccinated against COVID-19 or, if not, that they are legally entitled to an accommodation due to a medical condition or a sincerely held religious belief. Requests for accommodation will be considered on a case-by-case basis, and Kiniksa will consider, among other things whether a proposed accommodation would create an undue hardship.

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Posted 8/7/2024

HEAD OF ETHICS & BUSINESS INTEGRITY GOVERNANCE, OPERATIONS AND RISK MANAGEMENT - NORTH AMERICA AND GLOBAL SPECIALTY CARE - Sanofi
Location: US / Cambridge (U.S.) / Cambridge Crossing / 450 Water Street - Office Building

Job Description Summary
This position is responsible for the successful management of Sanofi's North America (NA) and Global Specialty Care Ethics & Business Integrity (E&BI) governance, operations, and risk management. This supervisory and strategic position will work collaboratively with Global E&BI, Finance, Internal Audit, and other functional and business areas to execute risk assessments, enhance the management of third-party compliance risk, oversee E&BI governance and operations (including Executive Compliance Committee and Aventis Board meetings), and provide compliance support for mergers & acquisitions. Integral parts of this role include identifying areas for continuous improvement, strategic planning and oversight of the enhancement of E&BI operations and systems across NA, and facilitating relationships with key stakeholders including the global E&BI leadership team, executives, Compliance Committee, and Board.

This management role will report to the VP, E&BI, NA and Global Specialty Care. This position oversees work conducted by direct reports and outside consultants. This role exercises independent judgment in assessing and providing strategic oversight of compliance-related matters.

I. Essential Job Duties and Responsibilities

Integrate automation, digitalization and process simplification to continuously improve Sanofi's compliance program
Provide day-to-day oversight of and enhance all elements of the NA E&BI Risk Assessment program and drive related strategic interface with other risk-management functions across NA, key business stakeholders, and the global E&BI risk management team
Manage and enhance the NA E&BI third-party risk, collaborations and business development program
Oversee NA E&BI Governance including managing Aventis Board and executive Compliance Committee materials; helping to further develop and track the E&BI NA compliance strategy; and strategic project management, function budget oversight, and vendor management
Oversee NA E&BI Compliance Operations, including maintaining / enhancing E&BI systems, overseeing the Conflict of Interest and Compliance Champions Programs; managing appropriate processes to satisfy required industry code and state compliance related certifications
Ability to prioritize multiple projects and responsibilities and effectively develop and oversee a team in a fast-paced environment, while maintaining positive collaborative relations with various senior stakeholders
Set strategic Risk Assessment priorities, working closely with global E&BI, Internal Controls & Audit
Maintain strict confidentiality and discretion
Assist with aspects of Sanofi's Corporate Integrity Agreement compliance

II. Required Educational Background and Job-Related Experience

Proven track record leading and managing risk assessments and third-party risk functions focused on issues such as bribery, fraud, corruption, and overall healthcare compliance.
Experience in developing and overseeing compliance program governance, systems, tools and resources
Established leadership skills, including managing and mentoring effective teams
Demonstrated ability to manage and lead change in a large, matrixed organization
Minimum of 10 years of life sciences/pharmaceutical/healthcare experience
Excellent written, oral, and presentation skills

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Posted 7/30/2024

SR. COMPLIANCE AND ETHICS SPECIALIST - Neurocrine Biosciences
Full Time
Location: On-Site, San Diego based US (min 40% travel)
Job Requisition ID: R4809

Who We Are:
At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs, but few options.

What We Do:
Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X (Formerly Twitter) and Facebook. (*in collaboration with AbbVie)

About the Role:
The Sr. Compliance and Ethics Specialist will be primarily responsible for executing key elements of Neurocrine's compliance monitoring program. The position will also support other compliance responsibilities including those related to internal investigations, training, communications, spend transparency, and special projects. The role is located at Neurocrine’s San Diego headquarters.

Your Contributions (include, but not limited to):

Conduct field and desk monitoring to ensure compliance with applicable laws, regulations, and Neurocrine policies
Assist in developing annual plans for monitoring activities such as Sales and Medical Affairs field rides and peer to peer educational program monitoring
Track and report progress of Compliance monitoring, including preparation of reports/metrics to communicate findings throughout multiple levels of the organization
Assist in the development and execution of compliance analytics that identify trends, patterns or outliers that help drive risk-based actions and decisions
Provide sound compliance guidance consistent with applicable laws, regulations and Neurocrine policies
Support additional compliance initiatives and projects

Requirements:

Bachelors degree or equivalent and 4+ years of relevant experience in the biotech/pharmaceutical or medical device industry
Compliance and Ethics Professional Certification preferred
Understanding of healthcare compliance laws, regulations, and industry codes applicable to a pharmaceutical company with a commercial product, including federal Anti-kickback Statute, FDA promotional regulations, federal and state spend transparency laws and the PhRMA Code
Experience in compliance solutions for data analytics, monitoring and risk management preferred
Strong ability to use word processing and presentation software to prepare documents and training, and to use spreadsheet and statistical analysis software to store, manipulate, analyze and present data
Ability to manage multiple projects, meet deadlines, and adjust to changes in priorities
Strong organizational skills and attention to detail
Strong data analytics skills
Strong critical thinking and problem-solving skills using creativity and sound judgment
Strong written, verbal, and listening skills
Strong teamwork and interdisciplinary collaboration skills
Flexible to travel (minimum 40% of time)
In-office 3+ days per week when not traveling
#LI-TM1

Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.

We are committed to building a diverse, equitable, and inclusive workplace, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description.

The annual base salary we reasonably expect to pay is $99,200.00-$143,675.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 20% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.

Apply here
Posted 7/26/2024

COMPLIANCE COUNSEL - Neurocrine Biosciences
Full Time
Location: On-Site, San Diego based US
Job Requisition ID: R4810

Who We Are:
At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs, but few options.

What We Do:
Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X (Formerly Twitter) and Facebook. (*in collaboration with AbbVie)

About the Role:
Responsible for compliance consultation, recommending solutions for and executing the Neurocrine Compliance and Ethics program to ensure compliance with all applicable laws and regulations.

Your Contributions (include, but not limited to):

Conducts compliance investigations regarding allegations of potential violations of law, company policy and/or ethical standards, prepares recommendations based on results of the investigations and implements corrective actions
Provides clear and sound compliance advice to stakeholders, management and employees at Neurocrine, consistent with applicable laws, regulations and Neurocrine policies
Proactively conducts field and desk monitoring to ensure compliance with applicable laws, regulations and Neurocrine policies
Provides proactive risk assessments regarding the compliance/ethics program and provides recommendations for updates/changes to the program or business operations as needed
Acts as advisor and provides compliance input and expertise into business decisions, including development of solutions-orientated risk mitigation strategies
Assists in addressing compliance training needs, helps to develop and deliver effective and creative training, including written materials, computer-based training and live presentations
Performs other duties as assigned/requested

Requirements:

Juris Doctorate Degree and 5+ years of legal and/or compliance experience
An active license to practice law in any state
Experience in the biotech/pharmaceutical or medical device industry
Experience with healthcare compliance investigations
Ability to deliver clear, concise and accurate advice, including the appropriate level of detail and anticipation of follow-up questions
Ability to build consensus with diverse stakeholders and third parties and form strong, collaborative working relationships with clients
Ability to anticipate business and industry issues; recommend relevant process improvements
Excellent interpersonal skills
Excellent communications, problem-solving, analytical thinking skills
Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
Ability to understand strategic direction and incorporate it into tactical plans
Team player focused on team and organizational success
Integrity, honesty, and trustworthiness are core operating principles
Flexible to travel (minimum 30% of time)
In-office 3+ days per week when not traveling
#LI-TM1

Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.

We are committed to building a diverse, equitable, and inclusive workplace, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description.

The annual base salary we reasonably expect to pay is $202,300.00-$292,975.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.

Apply here
Posted 7/26/2024

US INTEGRITY & COMPLIANCE OFFICER - Indivior
Full Time
Location: Richmond, VA US / Hybrid
Reports to: Deputy Compliance Officer

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

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

POSITION SUMMARY:
The U.S. Integrity & Compliance Officer (USICO) reports directly to the Deputy Compliance Officer (DCO) and assists the DCO with the day-to-day leadership and administration of the Indivior Global Integrity & Compliance Program (ICP).

The USICO serves as a strategic business partner and advisor across the U.S. Business Units (Behavioral Health, Addiction Sciences, Opioid Reversal Sciences) and Global Functions residing in the U.S. (e.g., Medical Affairs, R&D, Managed Care, Marketing, Government Affairs, Corporate Communications) to ensure the effective integration and implementation of the Indivior Global Integrity & Compliance Program. In this role the USICO will be responsible for providing timely proactive and daily compliance advisory counsel and compliant solutions approaches across the U.S. business, the annual administration of the U.S. I&C Risk Assessment and Mitigation Planning (RAMP) process with integration into the Global I&C RAMP, development/delivery of training, and participation in various compliance-related processes in collaboration with the Integrity & Compliance Centers of Excellence (e.g., monitoring, global strategy and program management, operations, reports communications, investigations (for subject matter expertise input only), governance committees, and government agreement administration).

The USICO is responsible to provide sound guidance and solutions that are in full compliance with the terms of Indivior Inc. Resolution Agreement (including CIA, DOJ Compliance Measures and FTC agreement).

The USICO is appointed to serve as Chairperson of the U.S. Compliance Administration Council (and may appoint a responsible delegate) and lead the I&C's policy governance program (with responsibility for all I&C Global and U.S. policies and procedures that are I&C-owned and in collaboration with those owned by other functions).

This position will have direct line reports and will also be responsible for indirect management of a network of Compliance Champions who support function level compliance activities.

ESSENTIAL FUNCTIONS:

Work collaboratively in the development and evolution of the ICP, under the direction of the DCO and as guided by the Indivior Global Integrity & Compliance Program multi-year maturity strategy. USICO efforts will ensure effective and appropriately paced maturity within the Indivior U.S. Business Units, and U.S.-based Global functions in coordination with the I&C Officers.
Lead and continually evolve the design, delivery and annual review of relevant I&C policies and SOPs based on U.S. laws, regulations, guidances, Industry Codes and Government Agreement requirements.
Provide daily support and guidance and proactive risk and solutions identification as a business advisor to assigned U.S. Business Units and U.S.-based Global Functions. The USICO will embed and facilitate ongoing evolution of the Indivior Global Integrity & Compliance Program and effective support of corporate goals, in coordination with I&C Officers.
Establish effective working relationships and build credibility within the Company, especially at senior management and operational leadership levels. The USICO will influence with and without direct authority to support a culture of integrity and compliance, confidence with quality decision making, and "speak up" without fear of retaliation.
Lead a team that conduct the annual U.S. RAMP within the U.S. Business Units and functions, and advise senior management and operational leadership on issues concerning integrity and compliance matters including recommending controls designed to ensure compliance, while building independent Risk IQ across Indivior Business Units and Functions. The U.S. RAMP as a component of the Global I&C RAMP program must be executed in full conformance for consistency in approach and outcomes management. As such, the responsibility for the Global RAMP program is a shared responsibility between the USICO and the other I&C Officers.
Build and develop highly engaged, effective team that consistently succeed in delivering value-added, timely, effective and pragmatic key stakeholder solutions that are risk and priority-based.
Collaborate across Integrity & Compliance (I&C) to share insights from role, with active participation in the development of all relevant I&C activities, policies, training to ensure fit-for-purpose based on risk mitigation and business needs.
Co-lead the effective design and delivery of relevant ad-hoc and standardized training for the U.S. Business Units and Functions together with the Global Training Center of Excellence.
Engage in I&C monitoring and audits as assigned. In this role, the expectation is to conduct a moderate quantity of field observations to help inform awareness of business practices, risks and opportunities.
Provide support for reports of concern assigned as "reviews" to the various functional areas for I&C advisory input.
Serve as lead or member of assigned compliance governance committees, demonstrating strong policy and process development, administration and regular evolution skills.
Engage in regular external networking and personal development to ensure maintenance of knowledge level of current regulations, Industry Codes and best practices (e.g., benchmarking), and strong working knowledge and application of Indivior policies and procedures, and all Indivior, Inc. Resolution Agreement requirements and commitments.
Carrying out other tasks and activities related to the development, execution and maintenance of the ICP as assigned.
Measure and report on Indivior Global I&C Program maturity initiatives and related progress, in addition to report development up to Board level for sufficient oversight based on the severity of any outcomes or matters under management (one on one, management committees, Board/Committees of the Board).
Report on CIA compliance and implementation to U.S. Government Office of Inspector General Monitors at quarterly meetings as topics warrant; presence at all meetings.

KEY CHALLENGES:

Engaging with diverse roles and individuals across U.S. region to ensure awareness, open dialogue and accessibility, while embedding confidence in ownership of compliance
Providing timely, proactive and pragmatic approaches to deliver solutions to business needs and challenges within the governing standards of the Indivior Global Integrity & Compliance Program
Effective time management and organization to manage multiple priorities, while simultaneously leading and driving key strategic priorities of the Integrity & Compliance function
Create clarity through measurement and reporting of results delivered in role
Effectively influencing quality decision making and change management while simultaneously driving an "operating with confidence" personal accountability; ensuring ownership and accountability for the ICP effectively rests with and is managed by the workforce at all levels of the organization

MINIMUM QUALIFICATIONS:
Education: BS/BA Undergraduate degree required.

Experience: Minimum 10 years of experience in either the pharmaceutical or medical device industry including a minimum of 5 years in a senior or regional healthcare compliance role and demonstrated experience effectively leading people in a supervisory capacity.

Detailed understanding of U.S. regulations (including Industry Codes governing healthcare compliance programs).
Strong interpersonal skills including ability to communicate effectively with people, individually and groups; ability to communicate with technical and non-technical colleagues; ability to develop important relationships with key stakeholders and work with all levels of management and employees, as well as with external partners and vendors.
Excellent interpersonal, communication and presentation skills, with the ability to communicate complex issues in a simple way and influence for greater outcomes.
Ability to work closely and collaboratively within Integrity & Compliance and with other business functions and Departments as well as key external stakeholders.
Highly impactful people leader skills and an effective driver of the change management process.
Experience in leading, planning, effectively executing and reporting on various healthcare compliance activities (e.g., training, risk management, monitoring).
Effectively demonstrate expertise in Healthcare Compliance, leading to personal credibility and trusted advisor status among key stakeholder groups.
Experience leading and advising within government agreement requirements and oversight is strongly preferred.
Professional Compliance Certification required
Law Degree or Master's Degree not required, but is preferred.

COMPETENCIES/CONDUCT:

Flexibility in thinking and pragmatic problem-solving skills
Excellent interpersonal, communication and presentation skills
Strong influencing skills and ability to exercise sound, consistent business judgment
Ability to work independently and manage a diverse and demanding workload
Willingness to work in a dynamic, fast-paced environment
High standards of professional integrity and independence, maintaining essential confidentiality.
Able to effectively influence senior management and functions to drive change
Displays a high sense of urgency and responsiveness, with quality and accuracy
Flexible to travel (minimum 40-60% of time)
Tenacity and robustness
Effectively demonstrate expertise in Healthcare Compliance, leading to personal credibility and trusted advisor status among key stakeholder groups

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

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

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

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

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

Apply here
Posted 7/25/2024

The Pharmaceutical Compliance Forum

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