The Pharmaceutical Compliance Forum

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EMPLOYMENT OPPORTUNITIES

 

COMPLIANCE ANALYST - Lundbeck Pharmaceuticals
Location: Deerfield, IL US


SUMMARY:
The Compliance Analyst will assist with the implementation of all elements of the Lundbeck North America Compliance Program, which are modeled after the seven elements of an effective compliance program. This role will work closely with key stakeholders and partner with lines of business (LOB) in support of Compliance and overall business objectives.

ESSENTIAL FUNCTIONS:

  • Policies, Procedures and Controls, including Code of Conduct: Responsible for supporting the ongoing maintenance and updates to steering documents, policies and procedures. Partners with LOB to assist with reviews, development and updating of directives, policies and procedures.
  • Training, Education and Communications: Support the implementation of the compliance training program in accordance with company directives, policies and procedures. Provide support for compliance communications program.
  • Investigations: Provide support for internal investigations relating to alleged compliance violations, as needed.
  • Monitoring and Auditing: Provide support for auditing and monitoring initiatives to ensure compliance with Lundbeck's policies and procedures. Assist with reviews and audits of key compliance risk areas, in accordance with the US monitoring program. Assist with auditing and monitoring programs and processes to ensure effectiveness of overall compliance program.
  • Assessments: Provide support for the development and implementation of assessments to determine effectiveness of Compliance trainings, education and other initiatives.
  • Compliance Program Projects and Workstreams: Provide support for all projects and workstreams in support of the Compliance Program.
  • System Support: Serve as system support specialist for the electronic learning management system (LMS), compliance program management software, and electronic steering document management system (LuDo).
  • Third Party Management: Provide support to track vendor budgets, facilitate the execution of vendor contracts and process invoices, as needed.
  • Advice, Guidance and Other Duties: Proactively provide day-to-day guidance to relevant business units on compliance matters. Help drive a compliant culture. Execute other duties as assigned by the Senior Manager, Compliance and Chief Compliance Officer.

REQUIRED EDUCATION, EXPERIENCE and SKILLS:

  • Accredited Bachelor's degree.
  • 2+ years of Compliance-related experience in the pharmaceutical, biotech or medical device industry or 2+ years of Compliance-related experience working for a vendor supporting the pharmaceutical, biotech or medical device industry.
  • Understanding of FDA rules and regulations and Fraud and Abuse Laws, such as the Anti-Kickback Statute and the False Claims Act.
  • Ability to communicate effectively with individuals at all levels, internally and externally.
  • Ability to effectively collaborate and problem solve.
  • Proactive, self-starter with a strong sense of ownership and accountability.
  • Strong planning, analytical, organizational, and time management skills.
  • Strong attention to detail.
  • Ability to function in a fast-paced environment handling multiple tasks simultaneously.
  • Demonstrated proficiency with Microsoft Office suite, including Teams, Excel, Word, and PowerPoint.

PREFERRED EDUCATION, EXPERIENCE and SKILLS:

  • 2+ years Compliance-related experience in the pharmaceutical industry.
  • Experience writing quality system documents in a Document Management system (such as Documentum and QDMS).
  • Project management experience.
  • Advanced Excel skills.

TRAVEL:

  • Willingness/Ability to travel up to 15% domestically. International travel may be required.

 Apply here
Posted 10/2/2020

BUSINESS ETHICS MONITORING ASSOCIATE DIRECTOR, NORTH AMERICA - Ipsen Bioscience, Inc.
Location: Cambridge, MA US


Job Description:
As the Business Ethics Monitoring Associate Director, you will be responsible for managing compliance processes, including the preparation, communication, implementation and monitoring of adherence to, policies and standards to promote compliance with legal and regulatory requirements. You will provide compliance advice and support to the company, its subsidiaries and affiliates, perform a variety of investigations, and follow-up on others, through resolution. You enjoy working collaboratively with other functional areas and also be comfortable with a significant degree of autonomy.

Your Role Will Involve

  • Developing and implementing the monitoring program, with trend reporting on identified risks
  • Leading US Business Ethics Monitoring program across all business units
  • Liaising with Global Business Ethics Monitoring to align on program objectives and share best practices
  • Performing live and transactional monitoring across three business units, as well as Medical Affairs and V&A activities.
  • Reporting monitoring results to business unit heads and other functional senior leaders to inform them of the findings, and work to address and remediate such findings through corrective and preventative action plans.
  • Advising and supporting business units and functional teams in the determination of remediation/CAPAs, their implementation and follow-up
  • Documenting and supporting the implementation of remediation/CAPAs to any monitoring findings
  • Leading US Third Party Due Diligence Program by working with the entire US organization
  • Liaising with Global 3rd Party Compliance Program lead to align on program objectives and share best practices
  • Overseeing implementation of compliance recommendations, including those that result from due diligence findings
  • Leading US compliance investigations with significant remediation efforts to resolution
  • Leading risk assessments, working with the Global Risk team and internal audit to review program compliance, and utilizing analytics to monitor it, identifying areas of risk and prioritize risk mitigation
  • Participating in the US Grants and Charitable Donations Committee as a voting member
  • Leading on implementation of compliance recommendations and documentation/records for commercial programs and initiatives
  • Preparing dispute resolution procedures and advising on process
  • Leading training initiatives, and developing the respective materials within areas of responsibility
  • Creating guidelines and tools, and advising different cross-functional teams to ensure compliance
  • Assisting with other compliance work as needed (may involve international matters)

In Return, You Will Bring

  • Bachelor's degree in related discipline
  • Advanced degree preferred – JD or Graduate Degree
  • 5+ Years Pharmaceutical industry experience required
  • 7+ years of Compliance experience
  • A history that shows an increase in responsibility and complexity (progression in responsibility and level)
  • A demonstrated aptitude and knowledge of the life sciences business model & commercial organization

If this sounds like an exciting opportunity to apply your pharmaceutical industry experience in our Global Business Ethics department, apply today!

IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

 Apply here
Posted 9/22/2020

MANAGER BUSINESS ETHICS OPERATIONS, NORTH AMERICA - Ipsen Bioscience, Inc.
Location: Cambridge, MA US


Job Description:
Do you enjoy giving advice and promoting business compliance?

You will be an integral member of a dynamic Global Business Ethics group and will be responsible for managing business ethics processes, including the preparation, communication, implementation and monitoring of adherence to, policies and standards to promote compliance with legal and regulatory requirements. You will provide business ethics advice and support to the company, its subsidiaries and affiliates as well as perform a variety of investigations, and follows-up on others, through resolution. You enjoy working collaboratively with other functional areas and be comfortable with a significant degree of autonomy. This is a great opportunity to be an integral part of a dynamic Global Business Ethics group.

Your Role Will Involve

  • Determining and owning Fair Market Value process of payments to HCPs, in accordance to the Anti-Kickback Statute and False Claims Act
  • Liaising with business partners on internal compliance program and quarterly integrated compliance discussions
  • Updating US Policies and Procedures, and managing our policy documents systems (MFiles)
  • Partnering with global compliance team on new Policies and SOPs, and leading roll-out and training to US organization, as needed
  • Implementing, managing, and training business partners the Business Ethics end-to-end system
  • Developing and implementing quarterly US Executive Dashboard; analyzing results, and reporting out
  • Providing operational support across all US Business Units, as well as Global R&D and Global Business Development
  • Overseeing compliance calendar of events, in alignment with broader company calendar
  • Collecting evidence and developing gap analysis of Business Ethics Program (Materials, Communications, Trainings, CAPAs, etc.)
  • Organizing and administering Annual Compliance Certifications for NA teams
  • Overseeing a cross-functional team that provides feedback on compliance activities from across the organization, and assisting in rolling out updates to policies, toolkits, etc.
  • Information Security Program
  • Overseeing & tracking NA Compliance team budget

In Return, You Will Bring

  • Bachelor's degree in related discipline; Graduate degree a plus
  • 5 + years of increasing responsibility and complexity in terms of any applicable professional experience
  • 2-4 years of compliance experience
  • Pharmaceutical industry experience required

If this sounds like an exciting opportunity to apply your pharmaceutical industry experience in our Global Business Ethics department, apply today!

IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

 Apply here
Posted 9/22/2020

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


Description:
Act as a trusted business partner to functional areas within Sales, Marketing, and HP Operations as assigned, to provide advice on daily business activities and ensure that business initiatives occur in accordance with all applicable laws, policies, and SOPs. Implement appropriate compliance controls as necessary, and provide requisite compliance education and training to assigned groups. Lead projects as assigned, using planning and organizing skills, as well as influencing and communication skills, to help the business easily incorporate compliance into their activities.

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Duties & Responsibilities:

  • Work as a contributing member of the Commercial Compliance team, as well as crossfunctionally across Ethics and Compliance, in the development, implementation, and continuous improvement of an effective compliance program for commercial business activities within BI. Integrate with assigned business units to be seen as a valued partner, who has a seat at the table and is consulted and advises on key business initiatives.
  • Take a leadership role with assigned business functions as their Compliance Business Partner, to advise on business activities and ensure alignment with company policies and SOPs.
  • Provide alternative recommendations as necessary to help the business achieve its goals in a compliant manner.
  • Lead projects as assigned. An example is the revising of policies and SOPs, and associated training of the business.
  • Use critical thinking and analytical skills, along with business and/or compliance experience, to provide guidance and make alternate recommendations to assigned business units on appropriate courses of action to enable the business to achieve its objectives in a compliant manner.
  • Draw upon knowledge of compliance environment and business experiences to inform these recommendations.
  • Use influencing skills, at all levels of the organization, to lead business colleagues in the application of compliance principles in their activities
  • Apply compliance competence to explain rationale behind advice provided, and logic of proposed solutions. An example of this is leveraging existing content in other forums. Strategically recognize the business value and efficiency, yet understand considerations such as transfer of value, control of proprietary content, and access by appropriate specialties. Candidate will be able to draw upon his/her experience base to balance these considerations in his/her advice and recommendations.
  • Lead identified project activities as assigned by the Director/Executive Director of Commercial Compliance. Examples may include the following:
    • Use of technology to bring compliance information to field teams by taking ownership of content submission, conduct needs analysis with users, and effectively address any gaps between needs and current content. This will require cross-E&C collaboration in content development.
    • Another possible example includes the revision/updating the Commercial Performance with Integrity Guide (or any governance document) as an enterprise-wide project with all stakeholders. This includes agency management, ensuring content accuracy with SMEs, obtaining appropriate Legal review, and creatively enhancing the document to ensure that it is a relevant and effective resource.
    • Creative dissemination, based on user feedback, of compliance resources to field teams to ensure proper uptake.
    • Additionally, an example may be leading the Compliance Field Advisory teams, where two-way dialogue occurs to ensure that Compliance is addressing field force needs, and field force colleagues are leading the implementation of compliance requirements. These Advisory Teams include personnel at the manager, senior manager, and director levels.
  • Provide updates and present on projects as requested to leadership of both the Ethics and Compliance department and as well as business leadership. This will require an executive presence to present and accept feedback at these senior levels.
  • Accept and incorporate feedback into project work, and advise leadership of enhancements and ongoing progress.
  • Demonstrate agility by flexibly adjusting to evolving business conditions and assignments, accountability by confidently taking ownership of his/her work and projects, and intrapreneurship by providing creative business solutions while recognizing existing and emerging areas of compliance risk. Takes appropriate steps to ensure risk mitigation.
  • Examples may include the following:
  • Working with the Auditing and Monitoring team to develop (and help execute if required) monitoring plans for new business activities, particularly those identified as high-risk. Do this proactively rather than reactively
  • Develop guidance for business activities to take place in new ways in response to external market dynamics (i.e. traditionally face-to-face activities done virtually, or interactions with customers taking place in non-traditional venues). Present these ideas effectively to business units for alignment.
  • Able to think strategically to recognize where additional training is required, and proactively develop and execute training activities for the business. For example, if a certain activity is resulting in numerous monitoring or and/or auditing findings, using analytical skills to recognize this trend, propose training and E&C leadership, and perform training where needed.

Requirements:

  • A Bachelor's Degree from an accredited institution required
  • Four to six (4-6) years of experience in business, legal, or related field in the Life Science, Pharma or other regulated industries
  • Commercial Compliance and/or business experience in two or more of the following areas required:
    • Professional Sales
    • Marketing
    • Speaker Bureau
    • Sample distribution and reconciliation
    • Vendor management
    • Payor Sales
    • Market Access
    • Patient Advocacy
    • Analytics and Insight
    • Sales Operations
    • Health Economics and Outcomes Research
    • Or similar business experience
  • Experience in project leadership, with the ability to manage multiple projects/assignments concurrently
  • Organizational awareness to recognize need for cross-functional collaboration
  • Strong influencing skills, to be able to communicate effectively and present ideas and solutions to all levels of the organization
  • Strong executive presence required to communicate effectively at all levels, including the senior leadership level
  • Demonstrated knowledge and understanding of the requirements for effective compliance programs as set forth in the U.S. Sentencing Guideline preferred
  • Demonstrated strong planning and organization skills
  • Detail-oriented with the ability lead multiple projects and meet multiple deadlines
  • Demonstrated ability to use critical thinking skills to make and apply fact-based analyses and decisions
  • Demonstrate a high degree of proficiency in the ability to interpret and apply information from spreadsheets, databases and project management systems
  • Self-starter, able to develop and learn new areas of compliance and risk areas
  • Ability to work with minimal supervision
  • Candidate should possess executive presence, to interact successfully with senior leadership
  • Influencing skills in securing buy-in to recommendations and business benefit
  • Strong conflict management skills
  • Must possess strong verbal, written, presentation and other communication skills
  • Must demonstrate ability to collaborate and partner across the organization

Eligibility Requirements:

  • Must be legally authorized to work in the United States without restriction.
  • Must be willing to take a drug test and post-offer physical (if required).
  • Must be 18 years of age or older.

Who We Are:
At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth.

Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA Inc., Boehringer Ingelheim Animal Health Puerto Rico LLC and Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative action employer 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; citizenship status, marital, domestic partnership or civil union status; gender, gender identity or expression; affectional or sexual orientation; pregnancy, childbirth or related medical condition; physical or psychiatric disability; veteran or military status; domestic violence victim status; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by applicable federal, state or local law.

 Apply here - Please use the following link to apply for this opportunity: Commercial Compliance Business Partner - Boehringer Ingelheim
Posted 8/25/2020

SR. DIRECTOR, US COMPLIANCE OFFICER - Greenwich Biosciences
Location: Carlsbad, CA US


About the role
The Sr, Director, US Compliance Officer manages critical compliance activities that are integral to the development, implementation and execution of the US Compliance and Ethics program, called I-CARE, to ensure corporate compliance with US legal requirements and industry codes of practice. This position reports to the Global Chief Compliance and Ethics Officer and will work closely with all areas the company to promote and ensure a culture of compliance, but with a primary focus on the US Commercial organization, to design, implement, and oversee the enforcement of US healthcare compliance policies and programs. An inspiring and engaging leader is sought to manage the US I-CARE team, work with senior leadership, and help lead the program throughout the organization. This position is not responsible for GxP compliance.

Responsibilities

  • Enhance, implement and maintain the US portion of the I-CARE Program, especially in respect to US Healthcare Compliance to promote an environment of compliance, integrity and ethical standards. Includes the development of initiatives, policies, and procedures and trainings.
    • Work with primarily US commercial and medical teams to develop, implement, review and update compliance policies and procedures.
    • Provide leadership/guidance for resolution of issues and ensures issues are investigated promptly and according to established procedures.
    • Ensure that initial and on-going training/education is provided to staff on compliance issues to contribute to a thorough understanding.
    • Ensure processes are in place for reporting, documenting, investigating and responding to compliance incidents.
    • Ensure that specialized training is provided in departments where documentation indicates a trend or pattern of non-compliance.
  • Oversee periodic monitoring/auditing activities to ensure on-going compliance and to assess for improvement of processes.
    • Providing metrics and represent US Compliance Committee at Global Compliance Committee meetings.
    • Monitor compliance activities and incident statistics for completion, and potential areas of risk.
    • Conduct assessments of existing practices; develop standards and procedures to support compliance.
    • Identify needs and opportunities, makes recommendations and works effectively and tactfully to correct deficiencies.
  • Assist the Global CCEO to oversee the development of the global I-CARE program, policies & trainings; the development of consistent, value-added, and timely information sharing or dialog about compliance initiatives to ensure effective operations, effective working relationships, and informed and engaged employees.
  • Serve as a leader and role model in support of GW's I-CARE program for Corporate Compliance and Business Integrity, demonstrating Compliance, Accountability, Respect and Ethical behavior.

Position Requirements

  • Bachelor's degree, combined with 10-15 years of experience in the pharmaceuticals or life sciences industry encompassing 5-15 years of compliance experience in progressively responsible roles. JD or equivalent legal qualification required.
  • CCEP, HCCA, or Seton Hall Healthcare Compliance or similar certification or Masters degree in corporate, healthcare and/or pharmaceutical compliance preferred
  • Proven leadership skills in developing, directing, organizing, managing, coordinating and monitoring complex processes.
  • Experience leading, inspiring and developing teams
  • Ability to manage organizational change, problem solve, make and implement high impact decisions.
  • Excellent analytical skills, including the ability to discern the nature of the problems presented and the practical application of regulatory and ethical requirements.
  • Good written and verbal communication skills to influence others and initiate change.
  • Ability to work well between functions and across all levels of the business.
  • Good working knowledge of personal computers and office software (word processing, spreadsheets, databases, and presentation packages).
  • Demonstrated ability and willingness to learn and apply new and upgraded systems to job responsibilities.
  • Ability to build consensus, and influence without authority to produce effective work results with a minimum of confusion; practices courtesy, tact and honesty in all internal and external work relationships.
  • Demonstrated success utilizing a variety of communication tools, from verbal communication to the use of current technology, one-to-one interactions and the facilitation of small group work sessions to company-wide distributions.

 Apply here
Posted 8/18/2020

CHIEF COMPLIANCE OFFICER - Optinose
Location: Yardley, Pennsylvania US
Reporting to: Chief Legal Officer
Position Classification: Full Time / Exempt


Primary Role / Job purpose
The Chief Compliance Officer is responsible for the Company's compliance program. The successful candidate will partner with the Optinose leadership team and operating units to ensure organizational compliance with applicable laws, industry requirements, and Company policies. This position reports to the Chief Legal Officer and has direct access to the Board of Directors and the Audit Committee for the purpose of reporting on compliance-related matters as appropriate.

The Chief Compliance Officer will establish standards and implement procedures to ensure that the Company's compliance program is effective and efficient in preventing, identifying, detecting, and correcting non-compliance. Specific responsibilities include, among other things, policy and process implementation, leading effective training programs, conducting internal monitoring and auditing, providing strategic risk management guidance, and directing investigations and corrective actions.

Key Responsibilities

  • Responsible for the continued development, operation, and oversight of the Company's compliance program.
  • Periodically report to the leadership team and Board of Directors regarding the design, operation, and effectiveness of the Company's compliance program.
  • Champion a corporate culture in which compliance is a key objective in business decision-making and processes and aligned with the Company's core values.
  • Provide guidance to leadership team, operational units and all employees on compliance matters and new developments.
  • Keep abreast of compliance trends, interpret law, and provide practical business solutions that maintain the Company's compliance within an evolving legal landscape.
  • Develop, implement, and periodically review policies and procedures governing business operations; ensuring compliance with laws and regulations applicable to the Company.
  • Develop, implement, and periodically review compliance training programs for new and existing employees to ensure a thorough understanding and appreciation of the laws that impact the Company's operations and how to conduct business practices appropriately.
  • Develop, implement, and periodically review auditing and monitoring plans for internal and external stakeholders.
  • Oversee business integrity hotline for the anonymous reporting of compliance concerns and conduct and/or facilitate investigations of suspected non-compliance, make recommendations regarding corrective action to the business unit and ensure completion of any corrective action.
  • Oversee all federal and state Sunshine reporting and related healthcare compliance requirements.
  • Serve as the Company's Privacy Officer.

Qualifications

  • Bachelor's degree required; JD or MBA strongly preferred.
  • At least 10 years of experience in a healthcare or corporate compliance role in the biotech/pharma/device industry, including at least 5 years in a leadership role.
  • Extensive knowledge of federal/state laws and industry requirements affecting the biotech/pharma/device industry, including data privacy laws.
  • Experience in conducting investigations and managing the investigative process.
  • Experience building/managing a compliance department within a small to mid-sized organization preferred.
  • Strong interpersonal, collaboration, negotiation, and communication skills.
  • Clear, concise, and persuasive writing and presentation skills.
  • Ability to manage a diverse and demanding workload and demonstrated adaptability with small company lean-resourced environment.
  • Strong orientation to deadline and detail.
  • Embrace and champion our core values.

Direct reports
One direct report.

Travel
Occasional travel may be required.

Equal Employment Opportunity
All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or protected veteran status. OptiNose Inc. takes affirmative action in support of its policy to employ and advance employment individuals who are minorities, women, protected veterans, and individuals with disabilities.

 Apply here
Posted 8/7/2020

MANAGER, COMPLIANCE - IMMUNOLOGY - AbbVie
Location: Lake County, Illinois
Compliance
2005864


About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Purpose:
The Manager of Compliance will provide direct oversight for basic and routine elements of AbbVie's compliance program. They will have a general working knowledge of AbbVie's business, the current compliance environment and the broader business impact of compliance issues to develop and provide solution-oriented compliance guidance related to AbbVie's compliance program for the company's Immunology Therapeutic Area. The manager may perform the following with moderate to significant supervision from Compliance Director, Immunology:

Responsibilities:

  • Serves as an active member of at least one business brand team.
  • Partners with all levels of key business functions to provide moderate OEC and functional policy interpretation and provide guidance on the requirements.
  • Assists or leads compliance risk assessments, trend analysis and provides recommendations for compliant business activities.
  • Conducts moderate policy and procedure reviews and updates related to OEC policy and functional procedures ensuring clarity, applicability and compliance.
  • Develops, delivers and updates OEC' s comprehensive training program on moderate OEC and functional policies and procedures, including the Operating Procedures for Program Funding and AbbVie's Code of Business Conduct, as well as the current compliance environment.
  • Develops, implements, modifies, and oversees corporate and/or functional monitoring plans and any corrective actions to ensure compliance with policies and procedures.
  • Assists OEC Director on compliance audits, when necessary, such as overseeing the fulfillment of auditors' requests and acting as a liaison between the business and auditors during on site activities.
  • Expected to evaluate and help respond to moderate to complex preliminary audit findings and recommendations, and to guide the business in preparing corrective action(s) to address moderate findings and recommendations, and work with the business to ensure timely completion.
  • Provides guidance on proposed business strategies and programs, identifies moderate legal and regulatory issues, analyzes alternatives and works with legal and other functions, as appropriate, to propose solutions to the business.
  • Possesses solid working knowledge of AbbVie's business, the current compliance environment, and the broader business impact.
  • Participates in cross-functional OEC programs and collaborates regularly with OEC colleagues to resolve issues and share learnings.

Key Leadership Competencies:

  • Builds strong relationships with peers and cross-functional partners outside of the team to enable higher performance
  • Learns fast, grasps the "essence" of issues and can change course quickly where indicated
  • Raises the bar and is never satisfied with the status quo

Qualifications:

  • BA/BS required, JD, PharmD, MD, DO, RN and/or MBA encouraged
  • Experience within pharmaceutical industry.
  • Minimum of 4 years' experience required with exposure to business functions such as compliance, legal, regulatory affairs, medical affairs and/or commercial

Significant Work Activities N/A
Travel No
Job Type Experienced
Schedule Full-time
Job Level Code M

Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.

 Apply here
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Posted 8/7/2020

ASSOCIATE DIRECTOR, COMPLIANCE - AbbVie
Location: Lake County, Illinois
Compliance
2005600


About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Purpose:
The Associate Director, Compliance will possess working knowledge of AbbVie's business, the current compliance environment and the broader business impact of compliance issues to develop and provide solution-oriented compliance guidance related to AbbVie's compliance program for the company's Immunology Therapeutic Area. The Associate Director will also provide direct oversight for moderate to complex elements of AbbVie's compliance program at the therapeutic area, business unit, functional or corporate level.

The Associate Director, Compliance may perform the following with limited supervision from the Compliance Director, Immunology

  • Partners with all levels of key business functions to provide moderate to complex OEC and functional policy interpretation and provide guidance on the requirements.
  • Conducts compliance risk assessments, trend analysis and provides recommendations for compliant business activities.
  • Conducts moderate to complex policy and procedure reviews and updates related to OEC policy and functional procedures ensuring clarity, applicability and compliance.
  • Develops, delivers and updates OEC' s comprehensive training program on moderate to complex OEC and functional policies and procedures, including the Operating Procedures for Program Funding and AbbVie's Code of Business Conduct, as well as the current compliance environment.
  • Develops, implements, modifies, and oversees corporate and/or functional monitoring plans and any corrective actions to ensure compliance with policies and procedures.
  • Assists OEC Director/ECO on compliance audits, when necessary, such as overseeing the fulfillment of auditors' requests and acting as a liaison between the business and auditors during on site activities. Expected to evaluate and help respond to moderate to complex preliminary audit findings and recommendations, and to guide the business in preparing corrective action(s) to address moderate to complex findings and recommendations, and work with the business to ensure timely completion.
  • Provides guidance on proposed business strategies and programs, identifies moderate to complex legal and regulatory issues, analyzes alternatives and works with legal and other functions, as appropriate, to propose solutions to the business.
  • Possesses solid working knowledge of AbbVie's business, the current compliance environment, and the broader business impact.
  • Participates in and may lead moderate to complex cross-functional OEC programs.

Qualifications

  • BA/BS required. CPA, Master's, JD, or equivalent work experience preferred.
  • Minimum of 5 years experience with, or exposure to, business functions such as compliance, legal, regulatory affairs, government affairs, and finance.
  • Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance.
  • Learns, fast, grasps the 'essence' and can change the course quickly where indicated.
  • Raises the bar and is never satisfied with the status quo.

Significant Work Activities N/A
Travel No
Job Type Experienced
Schedule Full-time
Job Level Code M

Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.

 Apply here
Posted 8/3/2020

ASSOCIATE DIRECTOR, ETHICS & COMPLIANCE TRAINING - Boehringer Ingelheim
Primary Location: Ridgefield, CT US - Flexible work remote options available


Designs, develops, delivers and maintains Ethics and Compliance training programs to all members of BIPI, BIUSA, BIAH and BIFI including identified training for relevant Third Parties acting on behalf of BI.

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Duties & Responsibilities:

  • Develop a multi-faceted and scalable strategy to address training and communications needs, including partnering with internal stakeholders to align on internal standards for various audiences and enhancing the use of digital training resources.
  • Demonstrated creative thinking and executional excellence/urgency that will include actively seeking out new, cutting edge technology to further improve training and communications initiatives, and building efficiency.
  • Perform enterprise wide gap analysis and ongoing assessment of Compliance training needs.
  • Design, develop training materials and implement compliance training programs and materials for employees of BI and identified Third Parties acting on behalf of BI.
    • Define training curriculum assignments in electronic training system
    • Maintain training materials with applicable current global procedures including applicable knowledge assessments
    • Ensure proper documentation of all training performed (LOS)
    • Participate in cross functional projects/activities and lead compliance training plan/activities as it relates to new activities
  • Ensure oversight of Third parties training plan for new third parties and monitor for completion
    • Ensure Refresher training are rolled out or ad hoc trainings as needed
    • Review and update third Party training curriculum as needed
  • Lead discussion on findings from monitoring and auditing activities for integration into training materials and Procedures as necessary.
  • Monitor mandatory training completion, and capture and report metrics on training completion.
  • Serve as Compliance Business Partner to HP Training and Development Executive Director.
  • Remain current with all Federal and State laws and regulations related to the Pharmaceutical industry.

Requirements:

  • Bachelor's degree from an accredited institution preferred
  • Five (5) years of Compliance training experience with degree, preferably in the Pharmaceutical/ Medical Device industry OR eight to ten (8-10) years of Training experience without degree
  • Experience in project management with the ability to manage multiple projects/assignments concurrently.
  • Demonstrated planning, organization skills.
  • Detail-oriented with strong execution skills and the ability to meet multiple deadlines.
  • Ability to identify problems and implement solutions.
  • Strong ability to influence and collaborate in a cross-functional team environment.
  • Possess adaptive style to navigate in an agile environment with frequent change.
  • Working knowledge of Microsoft suite of products including, Excel, PowerPoint, SharePoint, etc.
  • Demonstrated experience in project management with the ability to manage multiple projects/assignments concurrently.
  • Ability to effectively work with stakeholders at all levels and across the enterprise.
  • In-depth knowledge of US and Global Pharmaceutical Compliance requirements preferred
  • Multi-lingual ability a plus
  • Ability for travel

Eligibility Requirements:

  • Must be legally authorized to work in the United States without restriction.
  • Must be willing to take a drug test and post-offer physical (if required).
  • Must be 18 years of age or older.

Who We Are:
At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth. Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health.

Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA Inc., Boehringer Ingelheim Animal Health Puerto Rico LLC and Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative action employer 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; citizenship status, marital, domestic partnership or civil union status; gender, gender identity or expression; affectional or sexual orientation; pregnancy, childbirth or related medical condition; physical or psychiatric disability; veteran or military status; domestic violence victim status; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by applicable federal, state or local law.

 Apply here - Please use the following link to apply for this opportunity:
Associate Director Ethics & Compliance Training opportunity

Posted 7/23/2020