The Pharmaceutical Compliance Forum

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EMPLOYMENT OPPORTUNITIES

 

CORPORATE COMPLIANCE DIRECTOR - Indivior
Location: Slough


Indivior is a global specialty pharmaceutical company with a 20-year legacy of leadership in patient advocacy, health policy and evidence-based best practice models that have revolutionized modern addiction treatment. 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 - a chronic relapsing disease.

Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. The Indivior logo radiates its patient-focused, holistic focus on expanding access to quality treatment for addiction worldwide. The company has a strong pipeline of products and candidates designed to both expand on its heritage in global opioid dependence and address other chronic diseases of addiction - including opiate overdose, alcohol use disorders and cocaine intoxication - as well as related mental health disorders such as schizophrenia.

POSITION SUMMARY:
The Director, EMEA Corporate Compliance will be responsible for managing, enhancing and implementing Indivior's EMEA corporate compliance program and establishing clear policies and offering pragmatic guidance to the EMEA Area Business to help ensure compliance with applicable EU and local country laws, regulations and industry codes.

ESSENTIAL FUNCTIONS:

  • Leading the development, maintenance and evolution of policies, procedures and controls to help ensure compliance with Anti-Bribery and Anti-Corruption regulations and practices.
  • Developing, maintaining and disseminating EMEA Area Business corporate compliance policies, procedures and guidance materials, consistent with the Company's corporate compliance policies and guidelines, the Code of Business Conduct and underlying policies, other standard operating procedures, and pharmaceutical industry guidelines and best practices. This role will ensure alignment to local country requirements where appropriate ("Company Policies").
  • Participating or overseeing third-party due diligence assessments and monitoring processes for commercial distributors and other business partners.
  • Development and implementation of educational training programs on such EMEA and local country policies in appropriate language, along with monitoring completion of educational training programs.
  • Monitoring the EMEA Area Business functional leaders' compliance with Company Policies.
  • Facilitating and coordinating the development, maintenance and dissemination of other educational training content developed by members of the Corporate Compliance & Legal Departments.
  • Monitoring and assessing business practices and activities for compliance with Company Policies and assisting with the development and implementation of process and control enhancements.
  • Staying abreast of changes in pharmaceutical industry compliance standards for purpose of assessing and adopting changes to existing EMEA Area Business corporate compliance policies and SOPs.
  • Overseeing and providing Compliance certification of the Company's analysis and submission of payment reporting obligations and adherence to ABPI and EFPIA transparency requirements across EMEA business.
  • Chairing, participating and managing the EMEA Area Business's Compliance Committee and any local compliance committees.
  • Reporting of compliance matters to the Compliance Committee and Senior Management.
  • Carrying out other tasks and activities related to the development, execution and maintenance of the EMEA Area Business's compliance program.
  • Ensuring compliance across a wide geographic region with country variances
  • Providing pragmatic approach to deliver solutions in a commercial environment within a compliance framework
  • Implementing and driving compliance from regional to country level understanding within global framework of Indivior Code of Conduct.

MINIMUM QUALIFICATIONS:

  • BA (Hons) or BSc(Hons) 2.1 or above, educated
  • Law Degree not required, but is preferred
  • Minimum 7-10 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, with some personnel management responsibility
  • Detailed understanding of government regulations governing healthcare compliance programs.
  • Specific programmatic experience developing or executing Antibribery and Anti-Corruption compliance program
  • Ability to work closely and collaboratively with other business functions and Departments.
  • Strong project management skill set and a consistent driver of the change management process.
  • Experience in leading, planning, and conducting reporting on monitoring activities.

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

  • Flexibility in thinking and pragmatic problem-solving skills
  • Excellent interpersonal, communication and presentation skills.
  • Strong influencing skills and ability to exercise sound 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.
  • Able to effectively influence senior management and functions to drive change and improvement
  • Displays a high sense of urgency
  • Flexible to travel if required
  • Tenacity and robustness
  • The business language in Indivior is English, fluency in local languages advantageous

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 10/30/2018

DIRECTOR, COMPLIANCE OPERATIONS - Insmed
Department Name: Global Compliance
Manager Name & Title: Tiffany Cumming-Damiani, Executive Director, Corporate Compliance, Policies and Training
Effective Date: May 31, 2018 (updated Oct 5 2018)


Supervision of Others: (internal/external):

  • This position reports directly to the Executive Director, Corporate Compliance, Policies and Training
  • This is a non-supervisory position at this time and may change as the Global Compliance function grows.

General Purpose of Role:
With the Executive Director, Corporate Compliance, Policies and Training, implement and manage compliance operations functionality for Insmed's Global Compliance group and to provide guidance to Insmed's US and global (EU, Japan) operations. This role will be based at our Bridgewater, New Jersey headquarters location.

Responsibilities: Following is a list of essential duties, functions and responsibilities.

  • Implement and manage day-to-to operations for the hiring of healthcare professionals including process development, software implementation, fair market value and lifecycle management
  • Implement and manage US transparency program with scalability to global, including oversight of outsourced reporting vendor
  • Support policy and process development, updates and translations as assigned along with any training or communications
  • Partner with the US, EU and Japan businesses to provide guidance and support as needed
  • Provide guidance and support to US business
  • Identify continuous improvement activities to continue to enhance and grow the compliance function
  • Lead remediation efforts as needed, resulting from compliance monitoring and auditing

Position Requirements:

Knowledge & Experience

  • Knowledge of US and global compliance regulations, laws and standards
  • Experience working globally (EU, Japan)
  • Experience in engaging healthcare professionals processes
  • In depth knowledge of US transparency laws and reporting processes
  • Experience in developing and implement compliance processes and software (e.g. hiring healthcare professionals' software, third party due diligence software)
  • Experience in continuous improvement for compliance programs

Qualifications

  • Bachelor's degree required; advance degree preferred.
  • Compliance certification is a plus
  • At least 10 years' experience in corporate compliance for a pharmaceutical or biotech company

Skills

  • Must have excellent communication skills (verbal and written).
  • Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
  • Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).

Other (if applicable):

  • Domestic and international travel may be required occasionally (5-10%)
  • Must successfully exhibit Insmed's five (5) core corporate competencies of: Excellence, Accountability, Driven, Collaborative and Solutions; along with any other position specific competencies.
  • Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.

 Apply here
Posted 10/30/2018

ASSOCIATE DIRECTOR - ETHICS & COMPLIANCE OPERATIONS - Novo Nordisk

About the Department
At Novo Nordisk, we're committed to building the best Compliance team in the pharmaceutical industry. Operating at the highest ethical standards and ensuring adherence to corporate and legal regulations, the Compliance team is constantly called upon to design and implement creative solutions to complex issues. From training on new procedures, to auditing against local and corporate policies, to reporting compliance-related issues, Compliance keeps us accountable every step of the way as we develop life-changing therapies and bring them to market. At Novo Nordisk, you will be part of a company respected equally for its financial results and its business ethics. Are you ready to make a difference?

The Position
This position leads and manages the development and implementation of the U.S. healthcare ethics and compliance program function for compliance and department operations including department strategy, business planning, affiliate support and other key department processes. This position performs special projects, assists in development and execution of Ethics & Compliance (E&C) plan across functions/organizational lines, and provides additional leadership in Ethics and Compliance Department as requested.

Relationships
Reports to the Senior Director, Ethics & Compliance Operations, Monitoring & Auditing (M&A), and Government Accountability. Manages two or more Novo Nordisk Inc (NNI) E&C professionals and dedicated compliance professionals in Global Service Center (GSC), Bangalore. Internal relationships include in-house legal counsel, global compliance colleagues, senior leaders throughout lines of business. Supports North American affiliates (e.g. NNCI, NNRCSI). External relationships include vendors and consultants as well as developing and maintaining relationships with the broader E&C network within the industry.

Essential Functions

  • Supports the Senior Director in facilitating and raising awareness of the E&C program while fostering accountability for compliance throughout the organization
  • Fosters a continuous improvement mindset and proposes enhancements to the E&C program, informed by industry trends and best practices
  • Champions a proactive approach to E&C that is focused on partnership, prevent and risk mitigation
  • Participates in industry associations and engagements to raise the profile of the E&C Program
  • Operationalizes and implements holistic processes for business planning that ensures coordination of 1/3/5 year E&C and NNI milestones
  • Provides strategic E&C and operational support and guidance for North America affiliates related to ethics and compliance broadly, including relevant reporting requirements
  • Runs projects of varying size both within E&C and across NNI
  • Development and implementation of efficient systems, processes, and technologies to meet operational requirements (e.g., Exclusions processes, contracts, TPRs,)
  • Operationalizes key initiatives with the global Business E&C Office by supporting the strategic annual operations plan while understanding global and local impact
  • Creates annual plan for and manages GSC Bangalore office
  • Responsible for proactively identifying additional off shore/near shore work opportunities or enhancements
  • Provides direction for department operations functions, including planning key meetings, department wide development opportunities, and other functions
  • Works collaboratively with the Strategy & Education groups to support the development, implementation and maintenance of platforms and tools for employees and third parties to access company standards related to E&C
  • Ensures that the Circle of Excellence (COE) works cross-functionally to collaborate with business leaders to ensure that Standard Operating procedures (SOPs) are developed and implemented, as appropriate, to help enable the implementation of NNI's E&C policies
  • Continuously supports the enhancement of E&C communications, education and training
  • Creates content for key E&C Department meetings (e.g. off-sites, lunch & learns)
  • Manages E&C department related HR processes (e.g. JD updates, career frameworks)
  • Responsible for E&C department educational activities
  • Management of department budget and contracting processes, including forecasting expenditures and establishing practices that promote and support responsible spending, tracking and rationale regarding allocation
  • Manages the annual certification processes
  • Administrative support for the entire E&C Department
  • Provides additional support to the Government Accountability and E&C M&A functions as requested

Physical Requirements

  • 10-15% overnight travel required.

Development of People

  • Supervisory

Qualifications

  • A Bachelor's degree from an accredited institution is required. Additional education/certification within the compliance and health-care related fields is preferred
  • A minimum of 10+ years combined pharmaceutical, legal, regulatory, and compliance experience required OR 8+ years' experience if accompanied by an advanced degree or certification (e.g. MBA, JD, PMP)
  • Uncompromising ethics and high standard of personal integrity
  • Experience working under a government agreement (e.g. CIA, DPA, Consent Decree) is required
  • Demonstrates strong interpersonal skills and exceptional ability to influence at all levels of the organization
  • Demonstrated knowledge and understanding of the Anti-Kickback Statute and False Claims Act, FDA rules and regulations regarding the promotion of pharmaceuticals, corporate integrity agreements and other prosecution agreements with other pharmaceutical companies, PhRMA code and other relevant federal and state aggregate spend reporting requirements, and the current activities and developments involving pharmaceutical sales and marketing required
  • Demonstrated knowledge and clear understanding of the required elements of effective ethics and compliance programs as outlined in the Health & Human Services (HHS) Office of Inspector General (OIG) Compliance Program Guidance and the US Federal Sentencing Guidelines
  • Demonstrated ability to build and maintain effective strategic relationships and networks with internal and external stakeholders
  • Demonstrated ability to manage and lead change in a large, matrix organization
  • Effective time management skills
  • Communicates effectively with different audiences and in different contexts
  • Ability to drive multiple projects to completion meeting internal and external deliverables with high degree of accuracy
  • Prior experience managing professionals required
  • The ability to think objectively and use sound reasoning principles
  • Demonstrated strong interpersonal skills and ability to influence at all levels of the organization
  • Proficiency in MS Office Suite

Novo Nordisk is an Equal Opportunity Employer /F/Veteran/Disability/Sexual Orientation/Gender Identity.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
 Apply here
Posted 10/27/2018

ASSOCIATE DIRECTOR - ETHICS & COMPLIANCE RISK & MITIGATION - Novo Nordisk

About the Department
At Novo Nordisk, we're committed to building the best Compliance team in the pharmaceutical industry. Operating at the highest ethical standards and ensuring adherence to corporate and legal regulations, the Compliance team is constantly called upon to design and implement creative solutions to complex issues. From training on new procedures, to auditing against local and corporate policies, to reporting compliance-related issues, Compliance keeps us accountable every step of the way as we develop life-changing therapies and bring them to market. At Novo Nordisk, you will be part of a company respected equally for its financial results and its business ethics. Are you ready to make a difference?

The Position
This position supports the Director, E&C Strategy, Risk & Education with regard to the planning, design, and enablement of the NNI Ethics & Health Care Compliance Program strategy, as well as all aspects of the ethics and compliance risk management process. This position executes and supports the implementation of the Novo Nordisk Inc. ("NNI") Risk Assessment and Mitigation Program and is responsible for the management, tracking, and reporting of Ethics & Compliance ("E&C") risk assessments and the associated mitigation/remediation activities. This position also performs special projects within the department as requested.

Relationships
Directly supports the Director - Planning, Designing, and Enablement with regard to the execution of the Ethics & Compliance program. Closely collaborates with NNI's in-house legal counsel, other leaders across lines of business, and is a member of cross-functional teams throughout NNI. External relationships include vendors, outside counsel, industry peers, and government agencies.

Essential Functions

  • Raises awareness of the program and fosters accountability for ethics and compliance throughout the organization
  • Fosters a continuous improvement mindset and proposes enhancements to the Program informed by industry trends and best practices
  • Champions a proactive approach to ethics and compliance that is focused on partnership, prevention and risk mitigation
  • Participates in industry associations and engagements to raise the profile of the E&C Program and the company
  • Supports the Director in working with the CECO to ensure implementation of any external government reporting requirements
  • Supports Director in designing collaboratively NNI's ethics and compliance risk assessment process, framework, and methodology
  • Supports Director in leading collaboratively the implementation of ethics and compliance risk assessments
  • Supports Director in developing and driving a consistent definition of "ethics and compliance risk" across the organization
  • Supports Director in working collaboratively with ethics and compliance risk assessment cross-functional team members to identify, prioritize, and assign accountability for managing ethics and compliance risks throughout NNI's operations
  • Supports Director in working collaboratively with NNI's cross-functional ethics and compliance risk management stakeholders to develop risk mitigation plans and strives to hold risk owners accountable for action plan delivery and implementation
  • Supports Director in identifying and reporting high-level trends and insights to E&C peers and the broader organization; develops reports for executive leadership and multiple oversight committees
  • Supports Director in working closely with data gathering functions in other departments and identifies opportunities to leverage existing data sets for improved ethics and compliance trending and analytics
  • Supports Director in overseeing the implementation of mitigation plans and processes to facilitate appropriate triage, follow-up and close-out of identified health care compliance issues across all NNI products, therapeutic areas and functional areas
  • Supports Director in championing the implementation of new technologies to aid the risk assessment and mitigation process
  • Supports Director in actively overseeing stakeholder engagement, builds and maintains strategic relationships throughout NNI, and navigates the organization to facilitate risk assessment and mitigation efforts
  • Supports Director in working collaboratively with internal audit and monitoring functions to incorporate risk assessment results and emerging trends into auditing and monitoring plans

Physical Requirements

  • 0-10% overnight travel required.

Qualifications

  • A Bachelor's degree from an accredited institution is required. Additional education/certification within the compliance and health-care related fields is preferred
  • A minimum of 10 years combined pharmaceutical, legal, regulatory, and compliance experience required OR 8 years' experience if accompanied by an advanced degree or certification (e.g. MBA, JD, PMP)
  • Prior experience working under a government agreement (e.g. CIA, DPA, Consent Decree) required
  • Strong health care compliance background and clear understanding of elements of an effective ethics and compliance program
  • Maintains understanding of laws and regulations, enforcement actions and evolving best practices relevant to pharmaceutical ethics & compliance and proposes updates to Ethics & Compliance program, develops plan and deliverables to inform relevant internal functions
  • Uncompromising ethics and high standard of personal integrity
  • Excellent written and verbal communication and interpersonal skills required. Ability to interact with all levels of the business
  • Handles confidential information with discretion and uses information to inform strategic thinking and approach to compliance matters
  • Demonstrated ability in leadership/collaboration skills with the ability to develop and communicate a vision and engage people in that vision
  • Demonstrated ability to display expert level critical thinking in applying principles, theories and concepts on a wide range of problems
  • Demonstrated ability in creating strategic direction, plans and proven ability to drive and sustain business improvement and results
  • Communicates effectively with different audiences and in different contexts
  • Proficiency in Microsoft Office Suite

Novo Nordisk is an Equal Opportunity Employer /F/Veteran/Disability/Sexual Orientation/Gender Identity.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
 Apply here
Posted 10/27/2018

MANAGER - ETHICS AND COMPLIANCE MONITORING & AUDITING - Novo Nordisk

About the Department
At Novo Nordisk, we're committed to building the best Compliance team in the pharmaceutical industry. Operating at the highest ethical standards and ensuring adherence to corporate and legal regulations, the Compliance team is constantly called upon to design and implement creative solutions to complex issues. From training on new procedures, to auditing against local and corporate policies, to reporting compliance-related issues, Compliance keeps us accountable every step of the way as we develop life-changing therapies and bring them to market. At Novo Nordisk, you will be part of a company respected equally for its financial results and its business ethics. Are you ready to make a difference?

The Position
This position is responsible for executing against the Novo Nordisk Inc (NNI) Ethics and Compliance (E&C) Department's annual Monitoring & Auditing (M&A) strategic plan. This role will conduct monitoring activities and audits of various company records, manage the development and implementation of remediation processes, assist with investigations related to audit findings and allegations of non-compliance with Company policy, preparing regular reports and presentations in a form that is consistent with internal and external reporting requirements.

Relationships
Reports to the Associate Director - Monitoring & Auditing or designee. Closely collaborates with NNI's in-house legal counsel, leaders across lines of business, and is a member of cross-functional teams throughout NNI. The position will also interact with external customers including Health Care Professionals (HCP), third party/external vendors, and external consultants. This position may interact with government officials. This position may manage employees in NNI's Global Servicing Center in Bangalore.

Essential Functions

  • Support the Associate Director, Monitoring & Auditing in facilitating and raising awareness of the Ethics & Compliance program while fostering accountability for compliance throughout the organization
  • Maintain understanding of laws and regulations, enforcement actions and evolving practices relevant to pharmaceutical compliance and proposes updates to ethics & compliance program, as appropriate
  • Identify, analyze, and mitigate potential business ethics risks to the organization
  • Support the development and manage the implementation of a robust health care compliance monitoring and auditing plan
  • Develop and maintain knowledge and understanding of: (1) Novo Nordisk Diabetes, Obesity, and BioPharm disease state and products, (2) industry regulations and guidelines (e.g., laws and regulations regarding pharmaceutical advertising and promotion, Federal Anti-Kickback Statute, False Claims Act, PDMA), Novo Nordisk policies and procedures, and government reporting requirements as needed
  • Develop and manage protocols, guidelines and associated internal communication and documentation related to E&C testing and monitoring
  • Develop and manage the remediation and mitigation process on for the M&A team
  • Manage the full cycle of assigned review processes (e.g. management of third party vendors)
  • Review records and systems relating to interactions with healthcare professionals and institutions, conduct field monitoring visits and monitor various company-sponsored activities to ensure adherence with relevant laws, regulations, industry codes, and company policies
  • Support E&C audits for North America and NN affiliates (e.g. NNRCSI, Business Ethics & Compliance Office (BECO), LatAm) in support of annual auditing plan and/or ad hoc audits as requested
  • Review and follow-up on suspected areas of non-compliance and collaborate with NNI Ethics & Compliance teams as needed
  • Collaborate with compliance colleagues and line of business to help develop and implement remediation and mitigation plans
  • Prepare quarterly and ad hoc reports and presentations summarizing monitoring and auditing monitoring

Physical Requirements

  • 20-30% overnight travel required.

Qualifications

  • A Bachelor's degree from an accredited institution required
  • A minimum of 8 years combined pharmaceutical, legal, regulatory, and compliance experience required OR a minimum of 6 years' experience required if accompanied by an advanced degree or certificate (e.g. MBA, JD, PMP)
  • Demonstrated knowledge and understanding of the Anti-Kickback Statute and False Claims Act, Food and Drug Administration (FDA) rules and regulations regarding the promotion of pharmaceuticals, corporate integrity agreements, PhRMA code, and other relevant reporting requirements
  • Compliance auditing and/or monitoring experience in the Pharmaceutical or life sciences industry is required
  • Experience working under a government agreement (e.g. CIA, DPA, Consent Decree) is required
  • Demonstrates strong interpersonal skills and ability to influence at all levels of the organization
  • Excellent communication and organization skills
  • Excellent project management skills to oversee and drive project execution
  • Ability to manage multiple projects concurrently and collaborate across several functional areas
  • The ability to think objectively and use sound reasoning principles
  • Ability to manage multiple projects to completion meeting internal and external deliverables with high degree of accuracy
  • Excellent communication skills (written and verbal), strong report writing skills and organization skills are required
  • Uncompromising ethics and high standard of personal integrity
  • Ability to work proactively and independently with minimal supervision
  • Proficiency in Microsoft Office Suite
  • Supervisory experience preferred

Novo Nordisk is an Equal Opportunity Employer /F/Veteran/Disability/Sexual Orientation/Gender Identity.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
 Apply here
Posted 10/27/2018

MANAGER, OFFICE OF BUSINESS INTEGRITY AND ETHICS - Vertex Pharmaceuticals
Office of Business Integrity and Ethics
Boston, MA
Full-Time


Job Description
As part of the transformation and growth of its world-class compliance program, Vertex Pharmaceuticals is seeking an experienced candidate to join its Office of Business Integrity and Ethics (OBIE) team. OBIE serves as the primary contact for Vertex employees, shareholders, business partners, patients and the general public on issues relating to the implementation of and compliance with Vertex's Code of Conduct globally. The Office is accountable for supervising, coordinating and continuously improving Vertex's Compliance Program ("Program"). This includes defining compliance standards via policies and procedures, compliance training and communications, auditing and monitoring, facilitating internal reporting, compliance-related investigations, and keeping the Executive Committee and the Audit Committee of the Board of Directors informed on compliance matters.

Reporting to the Head of Global Operations, the Manager/Senior Manager will be responsible for supporting all aspects of the Global Operations Team, including policy creation and drafting, training and communications, transactional and live monitoring, auditing, and enhancing its Global Anti-Bribery/Anti-Corruption Program. The Manager/Senior Manager must have knowledge of the Anti-Kickback Statute and the Foreign Corrupt Practices Act and should have experience working with or for biotechnology/pharmaceutical companies on these issues. The Manager/Senior Manager will work collaboratively and strategically with colleagues in the Office of Business Integrity & Ethics, Legal and the business to drive a culture of ethics and integrity across Vertex's global organization. Be a key member of this dynamic team in Vertex's growing Department.

Responsibilities:

  • Evaluate and enhance Company policies, SOPs, guidelines, and associated internal communication and training plans related to key areas of vulnerability relevant to global pharmaceutical companies.
  • Prepare and deliver compliance-related training, including new hire training, annual Code of Conduct training, policy-related training and scenario-based training on ethical decision-making.
  • Maintain high level of knowledge of current and emerging laws and regulations and recent enforcement actions and inform and educate business units with tailored communications.
  • Monitor field Commercial, Medical Affairs and Managed Markets transactions, activities, and processes and perform transactional monitoring to assess compliance with Company policies and procedures.
  • Manage and prioritize multiple complex projects; collaborating with multi-functional subject matter experts and stakeholders, as required.
  • Prepare and provide reports, presentations, materials, guidelines, and documents for employees, senior management and the Board of Directors.
  • Design new and enhance existing processes, controls, and systems, including the fair market value process, to effectively address and mitigate key risks.
  • Partner with OBIE and Legal colleagues across regions to address issues and identify opportunities for collaboration, alignment, process improvement and best practice sharing.
  • Draft company-wide communications related to Program initiatives or enhancements
  • Develop and demonstrate knowledge and competency to serve as a compliance and ethics subject matter expert.

#LI-RS1

Minimum Qualifications

  • Candidates should have strong academic credentials and at least 3-4 years of experience in a law firm or as a compliance professional in a global life sciences company.
  • Knowledge of laws and regulations relating to prescription pharmaceuticals.
  • Outstanding written communication skills, with an ability to cogently and succinctly communicate complicated legal and compliance principles in a straightforward, understandable manner.
  • Strong ability to communicate with all levels of management and employees, both in writing and verbally.
  • Possess sound, practical judgment in the interpretation and application of relevant laws, regulations, industry standards and Company policies.
  • Self-motivated and able to work with minimal supervision; able to exercise sound judgment in resolving matters of moderate complexity or escalating matters appropriately.
  • Strong analytical skills (including skills analyzing large quantities of data) and critical thinking as well as demonstrated attention to detail.
  • Ability to handle multiple tasks in a fast-paced environment is essential.
  • Strong interpersonal skills, with ability to forge strong relationships with all levels of the organization, under challenging conditions and effective influencing skills with the ability to drive change as it relates to implementing remedial actions.
  • Excellent project management skills with the ability to organize and manage multiple priorities while meeting deadlines.
  • Confidence and professionalism to handle difficult conversations and discretion on sensitive matters.
  • Demonstrated strong commitment to compliance, ethics and accountability.

Preferred Qualifications

  • International experience.
  • Extensive experience with Microsoft PowerPoint and Excel.
  • Fluency in additional language(s).

Company Information
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. We discovered and developed the first medicines to treat the underlying cause of cystic fibrosis (CF), a rare, life-threatening genetic disease. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases.

Founded in 1989 in Cambridge, Mass., Vertex today has research and development sites and offices around the world. For several consecutive years, Science magazine has named Vertex one of its Top Employers in the life sciences. For additional information and the latest updates from the Company, please visit www.vrtx.com.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.

Req ID
10914BR

 Apply here
Posted 10/24/2018

HEALTH CARE COMPLIANCE SENIOR MANAGER - (180000F5) - Actelion Pharmaceuticals Ltd.


About the Company
Actelion Pharmaceuticals Ltd., a Janssen Pharmaceutical Company of Johnson & Johnson, is recruiting for Health Care Compliance Senior Manager.

As part of the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We collaborate with the world for the health of everyone in it.

Actelion is a leader in the field of pulmonary arterial hypertension (PAH). Our portfolio of PAH treatments covers the spectrum of disease, from WHO Functional Class (FC) II through to FC IV, with oral, inhaled and intravenous medications.

Job Summary
The Health Care Compliance Manager is responsible for collaborating with business partners and providing strategic guidance on commercial programs, initiatives and processes that have health care compliance-related implications. The Health Care Compliance Manger, in coordination with the Director, Health Care Compliance will provide direction and oversight of the Health Care Compliance (HCC) Program for multiple products within an Operating Company and ensure the business integrates health care compliance and corporate integrity principles into strategic plans and tactics.

Job Responsibilities
The Health Care Compliance Manager is responsible for the review of commercial strategies and material, such as field sales aids, informational brochures, professional and consumer marketing materials, public-relations materials, press releases, sales training documents, internal communications, brand business plans, field incentive compensation programs, and field call plans to facilitate compliant growth and ensure that materials comply with company policies and procedures including the Healthcare Regulatory Guidance Documents for Promotional & Marketing Practices, industry standards and applicable state and federal laws

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, oversight & monitoring, investigation and follow-ups. In consultation with the Health Care Compliance Officer, Human Resources, and the Law Department, responsible for ensuring there is a mechanism in place for appropriately disciplining 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 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.

Candidate Qualifications & Requirements
This job requires a combination of analytical, organizational and interpersonal skills. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

REQUIRED:

  • BA/BS with eight years relevant experience in the healthcare industry with knowledge of Health Care Compliance programs and policies, Federal health care programs, and FDA requirements ; equivalent combination of advanced degree and less experience may be considered.

PREFERRED:

  • Strong track record of working in a collaborative environment with demonstrated evidence of maintaining relationships and partnerships with peers and business partners
  • Broad business experience and a proven ability to influence business decisions and business partners
  • Demonstrated ability to analyze data and trends, and communicate complex information to all levels of the company required
  • Experience working with the governmental regulatory bodies and managing HCC company policies
  • 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
  • This position is located in San Francisco, CAL and requires travel up to approximately 20% of the time

If you are interested in making an impact by working in a culture of innovation, trust and teamwork, we welcome your application.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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Primary Location: US-CA-South San Francisco
Job: Legal & Intellectual Property & Compliance
Schedule: Full-time
Job Type: Standard
Job Posting: Oct 9, 2018

 Apply here
Posted 10/17/2018

DEPUTY, CHIEF COMPLIANCE OFFICER - Jazz Pharmaceuticals
Job Locations: US-PA-Philadelphia | US-CA-Palo Alto
Job ID: 2018-3865


Overview
Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.

Our therapeutic areas of focus include sleep and hematology/oncology - areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.

We are looking for the best and brightest talent to join our team. If you're looking to be a part of a company with an unwavering commitment to improving patients' lives and being a great place to work, we hope you'll explore our career openings and get to know Jazz Pharmaceuticals.

Position Profile

This opportunity is available in both Palo Alto, CA and Philadelphia, PA

This opportunity is available in both Palo Alto, CA and Philadelphia, PA The Deputy Chief Compliance Officer is responsible, on a global basis, for assisting the Chief Compliance Officer in designing, implementing, and maintaining an effective corporate compliance program. This person reports directly to the company's Chief Compliance Officer. He or she leads a team of experienced and highly-motivated compliance professionals who are charged with designing and delivering appropriate, risk-based compliance policies and procedures and monitoring, auditing and training programs in support of the Commercial, Medical, Clinical and Regulatory functions. The Deputy Chief Compliance Officer assists in ensuring that the corporate compliance program is effective and efficient in identifying, preventing, detecting, and correcting noncompliance by Jazz employees and business partners with applicable rules and regulations. This person oversees the compliance risk assessment process that is used to set annual team priorities and objectives and to formulate long-term strategic objectives of the compliance program. The role requires engagement and strong working relationships with members of other functions and cross-functional teams to ensure consistent understanding, application and implementation of corporate compliance policies and controls. He or she must have a thorough understanding of the laws, regulations and industry codes of practice applicable to pharmaceutical companies, as well as experience counseling senior management and other company employees regarding compliance risks.

Essential Functions

The Deputy Chief Compliance Officer:

  • Has significant day-to-day responsibility for managing the company's compliance program and leading the team responsible for day-to-day operation of the company's corporate compliance program;
  • Develops and executes annual compliance workplans and assists the Chief Compliance Officer with formulation and communication of the long-term strategic objectives of the corporate compliance program;
  • In conjunction with the Chief Compliance Officer, overseees all aspects of the company's corporate compliance program, including compliance policies and SOPs, training, monitoring and auditing activities, remediation of issues identified through compliance monitoring, the company's whistleblower hotlines and other elements of the corporate compliance program;
  • Implements and ensures adherence to potential Corporate Integrity Agreement obligations and reporting requirements;
  • Satisfies regulatory compliance requirements and implements industry best practices related to the development, commercialization and promotion of pharmaceutical products, with particular focus on the operations and activities of the Sales, Marketing, Market Access, Medical Affairs, Clinical and Regulatory functions;
  • Working with the Legal & Compliance Department and/or external law firms, investigates allegations relating to potential violations of the Code of Conduct, compliance policies and procedures, and legal and regulatory requirements;
  • Partners with management of other corporate functions on the continued education and enforcement of the corporate compliance program and coordinates with these other functional areas to effectuate and enhance compliance policies, procedures and systems controls as needed;
  • Consistently finds opportunities to strengthen and improve the culture of compliance at the company in positive ways, including by partnering with department and country heads to build relationships with the compliance function;
  • Counsels colleagues on appropriate relationships and interactions with healthcare professionals, patients, managed care entities, healthcare organizations and government officials and entities;
  • Responsible for ensuring the efficient and effective operation of the Compliance Committee, which consists of executive management and functional leaders;
  • Leads special projects and participates in cross-functional teams and committees;
  • Works closely with other functions to ensure consistency in approach across areas of the overall business and provides support for areas outside of his/her primary areas of responsibility as needed;
  • Educates clients regarding relevant legal updates, industry and regulatory developments, industry best practices, and risk mitigation solutions;
  • Fosters and supports the professional development of members of the Compliance Operations team; and
  • Supervises outside counsel and compliance advisors, as necessary.

Required Knowledge, Skills, and Abilities

  • Significant knowledge of and demonstrated experience advising business partners on compliance matters, including industry codes of practice related to interactions with healthcare professionals and patients, marketing strategies, promotional tactics and materials, direct-to-consumer advertising campaigns and programs, healthcare fraud and abuse, anti-kickback and anti-corruption issues, and other compliance matters related to the development and commercialization of pharmaceutical products.
  • Ability to identify emerging risks and trends, analyze and think strategically about complex risk issues and deliver solutions-oriented advice and solutions to mitigate or manage such risks.
  • Ability to drive, lead and oversee complex projects and lead them to successful completion in an organized, efficient, and effective manner.
  • Demonstrated experience prioritizing conflicting demands from multiple business functions and handling heavy workload in a fast-paced environment while remaining focused, organized and effective.
  • Demonstrated experience working in a global business and in managing employees in different locations.
  • Team player with strong interpersonal influencing and negotiation skills, and proven ability to communicate and work with all levels of the organization (including the field sales force). Expected to communicate effectively with personnel at all levels of the organization and to inspire confidence and support for compliance initiatives.
  • Experienced at making thoughtful risk management decisions and exercising excellent judgment under pressure and within tight timelines.
  • Excellent critical thinking skills; ability to work through complex issues, including those with significant strategic risk to company.
  • Ability to work both independently and collaboratively, with a record of establishing professional credibility and developing strong working relationships with executive management and colleagues across the organization.
  • Excellent communication skills - both oral and written - including experience with writing of policies and procedures and delivery of effective oral presentations on compliance topics and issues.
  • Experience making presentations to Boards of Directors and other executive management preferred.
  • Self-motivated, innovative, strategic, and detail-oriented.
  • Periodic travel throughout the United States and Europe is required.
  • Position is based in Palo Alto, CA or Philadelphia, PA.

Required/Preferred Education and Licenses

  • Juris Doctorate (J.D.) degree preferred, but MBA or equivalent advanced degree applicants considered.
  • Minimum 10+ years' industry-related experience in healthcare corporate compliance with a demonstrated in-depth understanding of applicable legal, regulatory, and compliance matters affecting global pharmaceutical companies with approved products.

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

 Apply here
Posted 10/3/2018

ETHICS & COMPLIANCE PARTNER - UCB


Help us transform patients' lives.

At UCB, we put our heart, soul and skills into making a difference for people living with severe disease. Working together to push the boundaries, we blend the best of our talents to unlock innovation. Will you join us in our pioneering adventure?

To strengthen our Ethics & Compliance team, we are looking for an Ethics & Compliance Partner.

Are you an Ethics & Compliance expert looking to make an impact on the lives of patients?

As an Ethics & Compliance Partner you will work in an environment where you will:

Be the front-line representative of E&C organization, and represent E&C in a responsible and professional manner while acting as a strategic business partner.

This role is responsible for providing subject matter expertise and leadership on compliance-related matters within the organization, ensuring that the supported Patient Value organization is educated on Ethics & Compliance standards, informed about Ethics & Compliance related risks, helping minimize those, building Ethics & Compliance by design in their initiatives and guiding their personnel through global processes, connecting them with local stakeholders as needed.

This role will be responsible to oversee regional initiatives and connect with local Ethics & Compliance colleagues, ensuring appropriate flow of information; connecting with E&C peers through formal and informal collaboration networks to ensure consistent application of E&C approaches and efficient sharing of best practices.

As the Ethics & Compliance Partner you will contribute by:
Maintaining thorough knowledge of all industry codes, laws, regulations, and monitor key developments that would impact the business. In collaboration with colleagues, advise the business regarding existing and future provisions. For future provisions, ensure appropriate planning and preparation where it will impact the business.

Drive risk assessments for compliance in the supported organization, informed by adequate monitoring and analytics, ensuring that key stakeholders are informed on relevant risks and implementing remediation plans, in collaboration with E&C Leadership.

Supporting development of Policies and Procedures as a subject matter expert.

Working with the relevant stakeholders to ensure regional organizations are educated and well informed about ethics & compliance policies and procedures.

Acting as a proactive strategic partner with the business to help them meet their goals and objectives in a compliant manner, analyzing alternatives and proposing solutions.

Co-creating and collaborating on business initiatives to foster innovation and creation of meaningful solutions for patients while ensuring integrity and ethical principles are respected.

Actively engaging the supported organization leadership in driving the tone in integrity from the top and leveraging communication cascaded to the organization to maintain a high level of awareness in ethical business conduct.

Key Stakeholders:

  • Patient Value Units Regional and Missions' teams
  • Patient Value Practices teams
  • PVU/PVP Legal Counsels, Talent and Finance Partners
  • Ethics & Compliance Area/Affiliate teams
  • Ethics & Compliance PVU/PVP partners and Regional Head

Competencies & Proficiency:

  • Demonstrates curiosity and interest in the knowledge and experiences of colleagues
  • Takes accountability for trying out new ideas and approaches
  • Identifies and raises potential delays in project planning, plus their associated risks
  • Builds, integrates and controls project planning, scheduling and resources
  • Effectively communicates with local and regional stakeholders to have an aligned and approved project plan
  • Propose ways of improvement in building and controlling project plans, in terms of accuracy and compliance risks
  • Demonstrates and encourages generosity and helpfulness by sharing knowledge, skills and resources to optimize and improve outcomes
  • Experience working in and being comfortable with matrix organization and reporting lines, and cross-functional teams without clear single leadership

Interested? For this position you'll need the following education, experience and skills:

  • Bachelor's Degree/Master's Degree preferred
  • Minimum of 3 years of experience in the pharmaceutical industry
  • Experience (direct or indirect - confronted and operated) in healthcare compliance
  • Proficiency in Healthcare Compliance rules and regulations including self-regulated industry codes (PhRMA)
  • Experience in a transnational and multicultural environment
  • Work effectively to design policies, management documents, presentations, control databases, KPI's, and dashboards

 Apply here
Posted 8/20/2018

DIRECTOR, N.A. ETHICS AND BUSINESS INTEGRITY - Sanofi


Position Location: Puerto Rico
The primary purpose of this position is to be the local Compliance business partner in Puerto Rico, establishing and maintaining the compliance program and sitting on the PR management team. This position will report directly into the North America, Ethics & Business Integrity department with a dotted line reporting relationship to the Vice President and General Manager of Puerto Rico.

The professional filling this position will be expected to operate independently, with limited oversight and guidance from North America, Ethics & Business Integrity. As a business partner, a significant portion of time will be dedicated to being the independent and local compliance expert (Policies and Processes) and resource for answering questions and providing guidance to management. This position will develop, implement and execute the local monitoring program as well as develop and deliver compliance training. This position will also perform local analysis of any compliance deviations and coordinate with the North America, Ethics & Business Integrity department on resolution to ensure consistency and will be a local resource to assist in investigations. This position will participate in other ad hoc requirements and projects as they arise.

Primary Roles and Responsibilities:
Independently create relationships with Puerto Rico Senior Management to establish themselves and the department as a trusted business partner and the key resource for compliance questions and guidance. This is a significant and one of the most important aspects of the position as the role will be ineffective without establishing a trusted relationship. Develop, implement, and maintain local compliance program in Puerto Rico

Work with Senior Director, North America Ethics & Business Integrity and Puerto Rico General Manager to develop the framework and structure of local Compliance structure.

Execute local monitoring program in Puerto Rico

  • Leverage the North America Compliance monitoring program to develop and implement a local monitoring of field activity
    • Participate in the random and/or targeted identification of sales representatives to be included in the monitoring process, including communications with selected reps, their direct managers and others as required, and documentation of these activities and coordination with participating members of the NA, Ethics & Business Integrity team.
    • Participate in the random and/or targeted identification of speaker programs to be included in the monitoring process, including communication with sponsoring reps, their direct managers and others as required, and documentation of these activities and coordination with participating members of the NA Compliance team.
    • Periodic field observations of sales representative activities and speaker programs, which will require a strong understanding of US Corporate Policies, and experience interacting with sales force personnel as well as demonstrated ability to think dynamically to answer questions and scenarios
  • Leverage the North America Compliance monitoring program to develop and implement a local monitoring over non filed compliance activity.


Perform / Support local analysis of compliance deviations

  • Perform analysis of compliance deviations that arise and coordinate with North America Ethics & Business Integrity on resolution, action to be taken and documentation.

Conduct Compliance Training

  • Identification of training needs based upon monitoring results, audit results, or through communications with key commercial personnel and/or leadership.

Support other Compliance activity in North America (25% + of time)

  • Assist the North America Compliance Officer in supporting other compliance activities in another 'country'; business unit and/or EBI home office monitoring activities as needed.
  • Demonstrate Sanofi values and commitment to compliance on a consistent basis

Qualifications:
A minimum of a Bachelor's Degree from an accredited four-year college or university with a focus in Compliance; Finance/Audit, and/or Legal is required. Advanced Degree is preferred. A minimum of 10 years of professional work experience is required. A minimum of 2 years of professional work experience within a Sales and Marketing Pharmaceutical Compliance function is required. Fluency in Spanish and English (speaking and writing skills) are required. Auditing and monitoring experience in a pharmaceutical environment (Sales and Marketing) is preferred. Previous experience with partnering with cross-functional business teams: i.e. Legal, Regulatory, Medical, Commercial, and/or R&D, while maintaining strict compliance with company policies and procedures is required. Previous experience within a formal advisory position to senior Leadership Team members is preferred. Selected candidate will possess the following ket area of competencies: Track record of establishing a trusted business partner relationship; Significant knowledge and understanding of pharmaceutical compliance (Sales and Marketing) environment and requirements, including the Food, Drug, and Cosmetics Act, the False Claims Act, state and federal Anti-Kickback Statutes and the Foreign Corrupt Practices Act; Proficient computer skills, including experience with MS programs is required; data mining skills are highly desirable; Project management experience and/or skills is preferred. This position may require up to 20% overall travel (Domestic and International).

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.

 Apply here
Posted 8/17/2018