The Pharmaceutical Compliance Forum

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EMPLOYMENT OPPORTUNITIES

 

EXECUTIVE DIRECTOR, GLOBAL COMPLIANCE - Incyte
Location: Incyte Corporate Headquarters, Wilmington, DE US


Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.

The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.

Job Summary (Primary function)
This position reports directly to Incyte's Chief Compliance Officer and is responsible for management and oversight of Incyte's Global Corporate Compliance Program, including responsibility for Incyte's ex-US affiliates and network of strategic partners and distributors. The role is located in Incyte's global headquarters and requires significant interaction with Incyte's Global and Regional Legal, Product Strategy, Information Technology, Medical Affairs, Product Strategy, Research and Development, and other company departments. This position will work to continuously enhance Incyte's Compliance program through application of best practices in the life sciences Compliance space.

Essential Functions of the Job (Key responsibilities)

  • Partner with business units to maintain an infrastructure that supports a company culture of compliance and recognizes that compliance is a collective responsibility of the all company employees.
    • Develop tools, processes and reports to support the business's ownership of Compliance
    • Provide guidance to the business and integrate compliance controls into the scope of existing business practices company-wide.
  • Work with the Chief Compliance Officer to coordinate the development and implementation of Incyte's internal Compliance processes to enhance and streamline policy, training, auditing, risk assessment, monitoring and investigation activities with a view toward global harmonization, automation and effective reporting.
  • Responsible for managing Incyte's ABAC Compliance program including applicable policies and training as well as systems/processes used to support Incyte's third party screening and diligence activities.
  • Coordinate with Incyte's Internal Audit and Compliance Monitoring functions to develop plans for ex-US audit and monitoring activities
  • Coordinate with Incyte's Compliance Risk function to develop annual risk assessments and build new risk assessments to address business expansion.
  • Responsible for Compliance support of Business Development activities (licensing, distributor and M&A arrangements) including due diligence, contract negotiation and ongoing support of compliance relationships with Incyte's strategic partners (running quarterly compliance meetings, maintaining compliance charters and certifications, developing a plan for partner reports, etc.)
  • Oversee and lead Incyte's regional/country compliance programs and manage regional/country compliance leads.
  • Act as business facing Compliance lead for Incyte's global, HQ-based functions including Global Medical Affairs, Development Operations, Publications and Global Product Strategy including responsibility for Compliance policies and training for these functions.
  • Provide regular updates and reports to the Chief Compliance Officer, the Compliance Committee, and senior and executive management on the operation and progress of compliance efforts and initiatives, audit findings, investigation outcomes, and project status updates.
  • Assist in compliance investigations involving potential violations of compliance policies, laws or regulations and overseeing corrective action.
  • Maintain a current working knowledge of various laws, regulations, and industry guidance that affect the corporate-wide compliance program, including federal and state government price reporting laws, state and federal privacy laws including GDPR, fraud and abuse and anti-kickback statutes, OIG guidelines, industry codes in relevant markets including PhRMA, EFPIA and JPMA, US state marketing compliance laws, FCPA, UK Bribery Act and other anti-bribery laws.

Qualifications (Minimal acceptable level of education, work experience, and competency)

  • Bachelor's degree required and Law degree preferred.
  • 10 or more years of pharmaceutical company compliance experience.
  • Proven record of accomplishment in the areas of global compliance best practices.
  • Knowledge of and experience with laws, regulations, and industry guidance that affect the pharmaceutical industry.
  • Strong public speaking skills and an ability to communicate in both verbal and written form with multiple stakeholders within and outside the company. Proficiency in PowerPoint.
  • Ability to lead and work effectively with cross functional teams and projects.
  • Strategic leadership capability, strong organizational awareness, sound judgment, strong business acumen and ability to make decisions with the input of appropriate input from multiple stakeholders.
  • Ability to effectively prioritize and work in a fast-paced environment and to handle multiple complex and confidential tasks.
  • Positive attitude and flexible mindset consistent with Incyte's company motto of "Solve On."

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.

We Respect Your Privacy

Learn more at: http://www.incyte.com/privacy-policy.

The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate. During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here. You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.

You can learn more about Incyte's data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable).

Please contact privacy@incyte.com if you have any questions or concerns or would like to exercise your rights.

Contact: Nick Foschi
Director, Human Resources
nfoschi@incyte.com
 Apply here
Posted 9/30/2021

HEALTH CARE COMPLIANCE OFFICER, SENIOR MANAGER - CV AND SCIENTIFIC AFFAIRS - Johnson & Johnson Services Inc.
Location: Titusville, New Jersey US


Job Description
Johnson & Johnson Services Inc. is recruiting for a Senior Manager to serve as Health Care Compliance Officer for the Cardiovascular (CV) and Janssen Scientific Affairs (JSA) organizations. This position will be based in Titusville NJ, with minor travel within the US possible.

Caring for the world, one person at a time, has inspired and united the people of Johnson & Johnson for 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

The Health Care Compliance Officer, Senior Manager will be responsible for collaborating with the CV and JSA business partners and providing strategic guidance on commercial sales and marketing, medical, scientific affairs, population health, value and evidence and access/payor related initiatives and processes that have health care compliance-related implications. The Health Care Compliance Officer will provide direction and oversight of the Health Care Compliance (HCC) Program for multiple products within Janssen Pharmaceuticals, Inc and ensure the business integrates health care compliance and corporate integrity principles into strategic plans and tactics.

Responsibilities:

  • The Health Care Compliance Officer 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.
  • Supervising the Manager, CV and JSA
  • Responsible for ensuring business activities comply with HCC laws, US federal and state regulations and industry standards, and company policies related but not limited to:
  • Selling, promotion, and marketing of health care products and services
  • Medical Affairs
  • Interactions with health care professionals and/or government officials
  • Counseling and training business partners on relevant laws and regulations as applicable
  • Transactional and compliance reporting
  • 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 within relevant HCC processes and systems (e.g., CLEAR Cause, MAPs, RAMPs, HIGHBOND, etc.)
  • Identifying potential HCC, GCC and privacy risks associated with commercial activities and ensuring involvement of appropriate individuals within HCC, Privacy, and Legal to provide appropriate guidance. In consultation with the Health Care Compliance Officer Director/Sr. Director, Human Resources, and the Law Department, responsible for ensuring there is a mechanism in place for appropriately disciplining instances of non-compliance and ensuring consistency in the application of disciplinary action.
  • The Health Care Compliance Officer will be accountable for communicating company healthcare compliance standards and information updates on new laws and guidance to committee members, key business partners and agencies.

Qualifications:
Required

  • A minimum of a Bachelor's degree
  • A minimum of 8 years of business experience
  • 5 years of experience in the healthcare industry with knowledge of Health Care Compliance programs and policies, Federal health care programs, and FDA requirements required
  • Consistent 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
  • Qualified candidates will have an engaging and personable demeanor; be self-directed, detail-oriented and motivated; demonstrate a high level of accountability, leadership, and decisiveness and the ability to prioritize, and execute on multiple and frequently changing priorities

Preferred

  • Experience in Cardiovascular or Scientific Affairs
  • Previous management of direct reports
  • Experience working with the governmental regulatory bodies and managing HCC company policies
  • Experience working as an HCC or GCC Officer or Manager
  • Experience developing and implementing one or more elements of a compliance program in accordance with an organization's risk profile.
  • Knowledge of commercial sales and marketing practices for healthcare products.
  • Experience working in a matrix environment to deliver solutions which drive compliant growth.
  • CCEP accreditation

This position is located in Titusville, NJ and may require approximately 15% domestic travel.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location: United States-New Jersey-Titusville-1125 Trenton Harbourton Road
Organization: Johnson & Johnson International (6078)
Job Function: Legal
Requisition ID: 2105972002W

 Apply here
Posted 9/30/2021

HEALTH CARE COMPLIANCE OFFICER, SENIOR MANAGER - IMMUNOLOGY - Johnson & Johnson Services Inc.
Location: Horsham, PA US


Job Description
Johnson & Johnson Services Inc. is currently recruiting for a Health Care Compliance Officer, Senior Manager - Immunology to be located in Horsham, PA.

Caring for the world, one person at a time, has inspired and united the people of Johnson & Johnson for 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

The Health Care Compliance Officer, Senior Manager will be responsible for collaborating with the Janssen Immunology business partners and providing strategic guidance on Medical Affairs and processes that have health care compliance-related implications. The Health Care Compliance Officer will provide direction and oversight of the Health Care Compliance (HCC) Program for multiple products within Janssen Pharmaceuticals, Inc and ensure the business integrates health care compliance and corporate integrity principles into strategic plans and tactics.

Responsibilities:

  • The Health Care Compliance Officer 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, field call plans, research proposals and medical education programs 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.
  • Responsible for ensuring business activities comply with HCC laws, US federal and state regulations and industry standards, and company policies related but not limited to:
  • Selling, promotion, and marketing of health care products and services
  • Interactions with health care professionals and/or government officials
  • Counseling and training business partners on relevant laws and regulations as applicable
  • Transactional and compliance reporting
  • 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 within relevant HCC processes and systems (e.g., CLEAR Cause, MAPs, RAMPs, HIGHBOND, etc.)
  • Identifying potential HCC, GCC and privacy risks associated with commercial activities and ensuring involvement of appropriate individuals within HCC, Privacy, and Legal to provide appropriate guidance. In consultation with the Health Care Compliance Officer Director/Sr. Director, Human Resources, and the Law Department, responsible for ensuring there is a mechanism in place for appropriately disciplining instances of non-compliance and ensuring consistency in the application of disciplinary action.
  • The Health Care Compliance Officer will be accountable for communicating company healthcare compliance standards and information updates on new laws and guidance to committee members, key business partners and agencies.

Qualifications:
Required

  • A minimum of a Bachelor's degree
  • A minimum of 8 years of business-related experience
  • 5 years of experience in the healthcare industry with knowledge of Health Care Compliance programs and policies, Federal health care programs, and FDA requirements
  • Consistent 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
  • Qualified candidates will have an engaging and personable demeanor; be self-directed, detail-oriented and motivated; demonstrate a high level of accountability, leadership, and decisiveness and the ability to prioritize, and execute on multiple and frequently changing priorities

Preferred

  • Immunology experience preferred
  • Previous experience in management of direct reports experience
  • Experience working with the governmental regulatory bodies and managing HCC company policies
  • Experience working as an HCC or GCC Officer or Manager
  • Experience developing and implementing one or more elements of a compliance program in accordance with an organization's risk profile
  • Knowledge of commercial sales, marketing and Medical Affairs practices for healthcare products.
  • Experience working in a matrix environment to deliver solutions which drive compliant growth.
  • CCEP accreditation preferred.

This position is located in Horsham, PA and may require approximately 10% domestic travel.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location: United States-Pennsylvania-Horsham-800/850 Ridgeview Drive
Organization: Johnson & Johnson Services Inc. (6090)
Job Function: Legal
Requisition ID: 2105970067W

 Apply here
Posted 9/30/2021

MANAGER - PHARMACEUTICAL & LIFE SCIENCES - StoneTurn
Location: flexible: NY, DC, Boston and Philadelphia, US


Do you want to work for a fast-paced, rapidly growing firm that values culture, work-life balance, and reputation above all? If so, StoneTurn could be the right fit for you.

StoneTurn, a global advisory firm, assists companies, their counsel and government agencies on regulatory, risk and compliance issues, investigations, and business disputes. We serve our clients from offices across the U.S., U.K., Germany, Brazil, and South Africa, assisted by a network of senior advisers around the world.

StoneTurn's leaders - partners and alumni of international public accounting and consulting firms, industry, and government agencies - opted for a different professional services model. Our vision is to create a highly collaborative team of professionals who prefer "hands-on" client service and focus on forming long-term, trusted relationships.

We are looking for a qualified Manager - Pharmaceutical & Life Sciences to join our Compliance, Monitoring and Analytics team. We are flexible on location along the east coast.

 Apply here

Your career on StoneTurn's Pharmaceutical & Life Sciences team will provide you with the opportunity to help companies rethink their approach to risk and create a sustainable risk advantage. You will work with a highly talented and seasoned team to assist clients develop and maintain innovative compliance solutions by leveraging data analytics and technology solutions to underpin efficient execution of governance, to optimize their risk and compliance policies, processes and systems, and enhance business performance.

In this position, you will be responsible for managing all or parts of client engagements, assisting with the development of our data analytics and compliance monitoring solutions and contributing to marketing efforts. You will add value to our team by having relevant professional services experience and/or relevant in-house experience. This position requires you to be a person with strong interpersonal, communication and technical skills.

Specifically, you will be responsible for managing client engagements for U.S., international and global life sciences companies; as well as assisting with developing progressive compliance strategies, evaluating and enhancing corporate and business compliance and ethics programs; designing and implementing innovative compliance monitoring solutions leveraging data analytics and emerging technology; conducting comprehensive, multi-jurisdictional risk and compliance program assessments (addressing ABAC, FCA, AKS, FDA promotional regulations, Privacy laws, OFAC, etc.); integrating compliance controls into operational and process excellence initiatives; and conducting complex internal investigations. You will have a deep understanding of the subject matter and be expected to collaborate with Managing Directors and Partners to lead business development efforts.

You will also be a part of the team working on the Firm's advanced Data Analytics & Compliance Monitoring initiative, a critical firm initiative. In this capacity, you will work with StoneTurn's dedicated Data Analytics team, and other sector-focused Managing Directors and Partners, to continue to advance the design and go-to-market market strategy for our data analytics and real-time compliance monitoring solutions.

Key Responsibilities

  • Manage the delivery on multiple engagements, supporting Managing Directors and the engagement team to ensure that the client's needs and expectations are properly addressed and that the work product is client-focused, clear, accurate, well-presented and of the highest quality
  • Contribute to analyses and reports for clients related to related to compliance and business controls
  • Assist with the performance of high-quality compliance assessments and analyses, program and process enhancement efforts, compliance strategy and execution, investigations and work product creation
  • Coordinate, as applicable, with all other StoneTurn practice areas to deliver services on compliance and monitoring services
  • Effectively manage risks associated with engagements
  • Stay abreast of all applicable U.S. and international laws, regulations, industry Codes, etc.
  • Research emerging issues and identify timely market facing opportunities
  • Assist with engagement management, including billing and conflict checks
  • Assist with marketing and networking initiatives, including thought leadership and digital engagement
  • Support Managing Directors and Partners with business development efforts
  • Help develop Senior Consultants and Consultants by providing timely performance feedback/training and conducting performance reviews

Required Qualifications

  • Bachelor's degree required
  • 7+ years of experience in a combination of in-house experience and professional services/consulting, with a focus on pharmaceutical and life sciences compliance
  • Experience creating and enhancing global compliance programs
  • Experience with building and progressing compliance monitoring programs
  • Experience conducting internal (or external) investigations
  • Flexibility with the potential travel requirements of client engagements (average 10 - 30%)
  • Strong managerial, leadership, organizational, and communication skills (both verbal and written)
  • Demonstrated ability to structure and perform technical projects, manage client expectations and relationships

Desired Qualifications

  • Master's or MBA degree
  • In-house experience
  • Compliance certifications
  • Good network of professionals within pharmaceutical and life science compliance (corporate, law firm, vendor, etc.)
  • Foreign language skills

We offer a competitive compensation and benefit packages.

Applicants for employment in U.S. must have work authorization that does not now or in the future require sponsorship by StoneTurn.

StoneTurn provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, veteran status or genetics.

Apply directly on StoneTurn's career page at http://stoneturn.hirecentric.com/jobs/. For additional information, go to http://www.stoneturn.com.

Posted 9/7/2021

MANAGING DIRECTOR - PHARMACEUTICAL & LIFE SCIENCES - StoneTurn
Location: flexible: NY, DC, Boston and Philadelphia, US


Do you want to work for a fast-paced, rapidly growing firm that values culture, work-life balance, and reputation above all? If so, StoneTurn could be the right fit for you.

StoneTurn, a global advisory firm, assists companies, their counsel and government agencies on regulatory, risk and compliance issues, investigations, and business disputes. We serve our clients from offices across the U.S., U.K., Germany, Brazil, and South Africa, assisted by a network of senior advisers around the world.

StoneTurn's leaders - partners and alumni of international public accounting and consulting firms, industry, and government agencies - opted for a different professional services model. Our vision is to create a highly collaborative team of professionals who prefer "hands-on" client service and focus on forming long-term, trusted relationships.

We are looking for a qualified Managing Director - Pharmaceutical & Life Sciences to join our Compliance, Monitoring and Analytics team. We are flexible on location along the east coast.

 Apply here

Your career on StoneTurn's Pharmaceutical & Life Sciences team will provide you with the opportunity to help companies rethink their approach to risk and create a sustainable risk advantage. You will work with a highly talented and seasoned team to assist clients develop and maintain innovative compliance solutions by leveraging data analytics and technology solutions to underpin efficient execution of governance, to optimize their risk and compliance policies, processes and systems, and enhance business performance.

In this position, you will be responsible for leading client engagements, driving the development of our data analytics and compliance monitoring solutions, leading marketing efforts and building out our team. You will add value to our team by having relevant professional services experience and experience in business development within the marketplace, as well as relevant in-house experience. This position requires you to be a person with strong interpersonal, communication and technical skills.

Specifically, you will be responsible for leading client engagements for U.S., international and global life sciences companies; assisting company Boards, senior management, and legal counsel by deploying highly experienced professionals to develop progressive compliance strategies, to evaluate and enhance corporate and business compliance and ethics programs; designing and implementing innovative compliance monitoring solutions leveraging data analytics and emerging technology; conducting comprehensive, multi-jurisdictional risk and compliance program assessments (addressing ABAC, FCA, AKS, FDA promotional regulations, Privacy laws, OFAC, etc.); integrating compliance controls into operational and process excellence initiatives; conducting complex internal investigations; and serving in independent oversight roles (e.g., monitorships) to ensure compliance with prescribed requirements. You will have a deep understanding of the subject matter and be expected to collaborate with Partners to lead business development efforts.

You will also be an integral part of the leadership team driving the Firm's advanced Data Analytics & Compliance Monitoring initiative, a critical firm initiative that is fully backed by leadership and carries significant investment. In this role, you will work with StoneTurn's dedicated Data Analytics team, and other sector-focused Partners, to continue to advance the design and go-to-market market strategy for our data analytics and real-time compliance monitoring solutions, including the development, with client partners, of the analytics platform and corresponding components (risk matrices, risk scoring, risk algorithms, analytics reporting, etc.).

Key Responsibilities

  • Lead the execution of multiple engagements, ensuring the engagement team understands the client's needs and expectations and that the work product is client-focused, clear, accurate, well-presented and of the highest quality
  • Create analyses and reports for clients related to related to compliance and business controls
  • Direct and assist in the performance of high-quality compliance assessments and analyses, program and process enhancement efforts, compliance strategy and execution, investigations and work product creation
  • Integrate with all other StoneTurn practice areas to deliver coordinated services on compliance and monitoring services
  • Effectively manage risks associated with engagements
  • Stay abreast of all applicable U.S. and international laws, regulations, industry Codes, etc.
  • Research emerging issues and identify timely market facing opportunities
  • Assist with engagement management, including billing and conflict checks
  • Lead and participate in marketing and networking initiatives, including thought leadership and digital engagement
  • Lead business development efforts, including developing and maintaining external and internal client relationships
  • Mentor and develop Managers, Senior Consultants and Consultants by providing timely performance feedback/training and conducting performance reviews

Required Qualifications

  • Bachelor's degree required, advanced degree a plus
  • 10+ years of experience in a combination of in-house experience and professional services/consulting, with a focus on pharmaceutical and life sciences compliance
  • Experience creating and enhancing global compliance programs.
  • Experience conducting internal (or external) investigations.
  • Flexibility with the potential travel requirements of client engagements (average 10 - 30%).
  • Excellent managerial, leadership, organizational, and communication skills (both verbal and written).
  • Demonstrated ability to structure and perform technical projects, manage client expectations and relationships.

Desired Qualifications

  • Master's or MBA degree.
  • In-house experience
  • Government experience
  • Experience within CFIUS, a plus.
  • Certifications including Export Compliance Professional (ECoP┬«) and Certified U.S. Export Compliance Officer (CUSECO┬«).
  • Strong network of professionals within global trade compliance.
  • Foreign language skills.

We offer a competitive compensation and benefit packages.

Applicants for employment in U.S. must have work authorization that does not now or in the future require sponsorship by StoneTurn.

StoneTurn provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, veteran status or genetics.

Apply directly on StoneTurn's career page at http://stoneturn.hirecentric.com/jobs/. For additional information, go to www.stoneturn.com.

Posted 9/7/2021

DIRECTOR, COMPLIANCE POLICIES & LEARNING - Moderna
Location: Cambridge, Massachusetts US


The Role:
The Director, Compliance Policies & Learning, will transition our corporate policy and training framework to engaging, story-based content, including use of live-action and animated videos that can be leveraged across multiple platforms and at multiple times to create an accessible educational ecosystem, ensuring expectations are communicated clearly and retained by employees. This role requires an creative thinker who can balance traditional responsibilities such as maintaining a governance and oversight framework for corporate policy documents, ensuring training on these documents is appropriately assigned and completed, and maintaining compliance policies and procedures, while evangelizing the benefits of narrative-based, just-in-time communications to improve abilities to understand how to comply.

Here's What You'll Do:

  • Continue to build our corporate policy framework and governance, using new concepts and technologies, by:
    • Identifying needs and expectations for the corporate policy framework, then transition our existing framework to support lightweight, principles-based, corporate policies with guidance to ensure a base consistency between them;
    • Encouraging use of story-based compliance information to further develop our procedural documents, and demonstrate its value by leveraging compliance policies and procedures as examples of success; and
    • Measuring policy message success via feedback gathering methods, usage metrics, and via collaboration with the Director, Compliance Monitoring & Investigations to leverage data that indicates where employees may need more guidance.
  • Improve policy message retention by:
    • Partnering with Learning Management to rethink the traditional policy/training assignment model, leveraging digital technologies that provide narrative-based content just-in-time and aligned to what employees are doing in that moment;
    • Demonstrating what works best in partnership with the Director, Compliance Monitoring & Investigations to ensure visibility into which narratives and techniques yield the most improved results; and
    • Evangelizing continuous improvement in policy training, shifting from training assignment and reminders to serving up helpful education content just-in-time and embedded within business process.
  • Enhance our compliance program by:
    • Establishing compliance narratives to enforce key messages on critical expectations (anti-bribery, promotional integrity, external interactions) and curate content to continually improve, leveraging mixed media, with heavy reliance on video and digital formats; and
    • Leveraging our Values Basecamp - Integrity, Quality, Respect - while actively leading or contributing to other corporate compliance initiatives to ensure seamless integration across the compliance program, and escalating issues to Compliance leadership.

Here's What You'll Bring to the Table:

  • 7-10+ years of diversified biotech/pharmaceutical industry experience, including a minimum of 5 years of experience in policy document management.
  • Juris Doctorate (JD) not required.
  • Demonstrated willingness to roll up sleeves to and do the work vs. manage, while building out the functional capabilities.
  • Ability to interact collaboratively, yet objectively with all levels of management.
  • Ability to prioritize and direct limited resources to the most critical areas and issues; build solid, collaborative working relationships across multiple functions; and drive improvement initiatives with a sense of urgency.
  • Working knowledge of major business processes and compliance/risk issues related to the bio-pharmaceutical industry.
  • Solid knowledge of compliance program frameworks and a passion to continuously improve.

 Apply here
Posted 8/16/2021

DIRECTOR, COMPLIANCE MONITORING, AUDITING AND INVESTIGATIONS - Moderna
Location: Cambridge, Massachusetts US


The Role:
The Director, Compliance Monitoring and Investigations will innovate, enhance and implement compliance monitoring and investigative capabilities. In addition to expanding our traditional monitoring and investigative capabilities, the Director will need to leverage technology and outside-the-box thinking to structure these capabilities with the purpose of mentoring the organization to grow and advance our mission of making mRNA medicines a reality for patients. The Director, Compliance Monitoring and Investigations, will expand and ensure the effective operation of our compliance monitoring, third party due diligence, and hotline and investigation capabilities, including conducting investigations as required. This role requires a unique individual with strong emotional intelligence and proven track record communicating on difficult topics in a positive manner, stressing the important learning and improvements that can be made.

Here's What You'll Do:

  • Design and implement an innovative, comprehensive, and integrated compliance monitoring and audit program, centered on a rolling 3-year plan, including:
    • Advocating for and demonstrating the value of automated monitoring that includes employees and managers in the process via a mentorship mindset, yielding improved results and reduced risk of compliance failures;
    • Ensuring that compliance monitoring and audit results seamlessly flow into Integrated Risk Management to inform company risk management decisions;
    • Enhancing our third-party due diligence program, ensuring alignment with the Director, Third Party Risk Management and the Vice President, Internal Audit;
    • Finding opportunities to collaborate with key stakeholders, including Internal Audit, Quality, Trade Compliance, and Corporate Security to improve our overall capability to detect and remediate issues before they become significant to the company.
  • Reinforce and expand our speak-up culture and improve our investigative capabilities by:
    • Partnering with Legal, Human Resources, and Corporate Security to include enhanced hotline and investigation support tools, aligned processes, and investigation procedures;
    • Leveraging the enhanced hotline as a communications tool to remind employees of our expectations that they will speak up and ask questions; and
    • Encouraging feedback to improve our ability to respectfully and productively engage employees and other stakeholders in challenging conversations.
  • Enhance our compliance program by:
    • Actively conducting monitoring, audits, due diligence, and investigations as needed;
    • Creating a mentoring plan to leverage compliance monitoring and auditing results and investigation trends to become learning opportunities for the organization;
    • Advocating increased use of technology in conjunction with Internal Audit, Quality, and other functions to eliminate duplication of effort and maximize cross-functional reliance; and
    • Leveraging our Values Basecamp - Integrity, Quality, Respect - while actively leading or contributing to other corporate compliance initiatives to ensure seamless integration across the compliance program, and escalating issues to Compliance leadership.

Here's What You'll Bring to the Table:

  • 7-10+ years of diversified biotech/pharmaceutical industry experience, including a minimum of 5 years of experience in compliance monitoring or audit.
  • Juris Doctorate (JD) not required.
  • Prior experience with corporate investigations.
  • Demonstrated willingness to roll up sleeves to and do the work vs. manage, while building out the functional capabilities.
  • Proven experience in aligning monitoring, auditing, and investigative processes to ensure continuous improvement across multiple functions in a global company.
  • Ability to interact collaboratively, yet objectively with all levels of management.
  • Ability to prioritize and direct limited resources to the most critical areas and issues; build solid, collaborative working relationships across multiple functions; and drive improvement initiatives with a sense of urgency.
  • Working knowledge of major business processes and compliance/risk issues related to the bio-pharmaceutical industry.
  • Solid knowledge of compliance program frameworks and a passion to continuously improve.
 Apply here
Posted 8/16/2021

COMPLIANCE MANAGER/SR. MANAGER - Harmony Biosciences, LLC
Location: Plymouth Meeting, PA US
Department: Compliance
Reports to: Director, Compliance


SUMMARY: Reporting to the Sr. Director, Compliance, the Compliance Manager/Sr. Manager will help execute elements of the Company's healthcare compliance program, with an emphasis on auditing and monitoring of business activities and HCP payment transparency reporting. In addition, the candidate for this position will work closely with the Chief Compliance Officer, Sr. Director, Compliance and business colleagues and shall assist with managing Harmony's compliance with all applicable laws, regulations, guidance and industry standards including those of the FDA, OIG and CMS, and applicable fraud and abuse, Privacy and federal and state transparency laws.

DUTIES AND RESPONSIBILITIES:

  • Help drive a culture of compliance throughout the organization and promote various compliance policies, procedures and initiatives.
  • Implement and continuously improve the healthcare compliance program, including, but not limited to, developing policies, conducting training, auditing and monitoring, and conducting investigations.
  • Conduct field ride-alongs and speaker program observations to monitor key compliance risk areas. Draft reports and identify/implement corrective actions.
  • Assist in the completion of activities related to federal and relevant state transparency-driven compliance requirements.
  • Review and critically analyze data to determine instances of suspected fraud, abuse or non-compliance.
  • Provide advice and support to Commercial, Medical, Clinical Operations and other key business stakeholders related to healthcare compliance.
  • Develop and implement tools which empower business stakeholders to make ethical and compliant decisions.
  • Assist in managing compliance training requirements and conducting required training classes.
  • Maintain current understanding of laws, regulations and industry codes applicable to pharmaceutical/biotechnology business activities and Compliance, along with recent trends and changes, and help provide related internal education and training.
  • Additional responsibilities as assigned.

SUPERVISORY RESPONSIBILITIES:

  • This job has no supervisory responsibilities.

QUALIFICATIONS:

  • Bachelors' degree required
  • Minimum 3 years of experience in a regulated industry preferably in the Life Science Industry
  • Experience performing monitoring and auditing activities preferably in the Life Science Industry
  • Knowledge of the laws, regulations, guidelines and codes impacting the industry, particularly Federal and State transparency reporting laws is a plus
  • Excellent project management, problem-solving and organizational skills
  • Excellent professional verbal and technical writing skills
  • High level of professional discretion and diplomacy; able to strictly maintain confidential information
  • Strong presentation skills and comfortable presenting to both small and large groups
  • Innovative and forward-thinking
  • Experience with business expenditure applications, travel and expense reporting tools and other financial applications is required. Experience with hosted aggregate spend applications and business intelligence tools is a plus
  • Excellent analytical and communication skills with the ability to support customers at all levels

QUALIFICATIONS:

  • Adaptability - adapts to changes in the work environment; manages competing demands; changes approach or method to best fit the situation; able to deal with frequent change, delays, or unexpected events.
  • Analytical - synthesizes complex or diverse information; collects and researches data; uses intuition and experience to complement data; designs workflows and procedures.
  • Attendance/Punctuality - is consistently at work and on time; ensures work responsibilities are covered when absent; arrives at meetings and appointments on time.
  • Business Acumen - understands business implications of decisions; displays orientation to profitability; demonstrates knowledge of market and competition; aligns work with strategic goals.
  • Change Management - develops workable implementation plans; communicates changes effectively; builds commitment and overcomes resistance; prepares and supports those affected by change; monitors transition and evaluates results.
  • Cost Consciousness - works within approved budget; develops and implements cost saving measures; contributes to profits and revenue; conserves organizational resources.
  • Dependability - follows instructions, responds to management direction; takes responsibility for own actions; keeps commitments; commits to long hours of work when necessary to reach goals; completes tasks on time or notifies appropriate person with an alternate plan.
  • Diversity - demonstrates knowledge of EEOC policy; shows respect and sensitivity for cultural differences; educates others on the value of diversity; promotes a harassment-free environment; builds a diverse workforce.
  • Ethics - treats people with respect; keeps commitments; inspires the trust of others; works with integrity and ethically; upholds organizational values.
  • Initiative - volunteers readily; undertakes self-development activities; seeks increased responsibilities; takes independent actions and calculated risks; looks for and takes advantage of opportunities; asks for and offers help when needed.
  • Innovation - displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others' attention.
  • Interpersonal Skills - focuses on solving conflict, not blaming; maintains confidentiality; listens to others without interrupting; keeps emotions under control; remains open to others' ideas and tries new things.
  • Judgement - displays willingness to make decisions; exhibits sound and accurate judgment; supports and explains reasoning for decisions; includes appropriate people in decision-making process; makes timely decisions.
  • Leadership - exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others; accepts feedback from others; gives appropriate recognition to others.
  • Managing People - includes staff in planning, decision-making, facilitating and process improvement; takes responsibility for subordinates' activities; makes self-available to staff; provides regular performance feedback; develops subordinates' skills and encourages growth; solicits and applies customer feedback (internal and external); fosters quality focus in others; improves processes, products and services.; continually works to improve supervisory skills.
  • Motivation - sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence; takes calculated risks to accomplish goals.
  • Oral Communication - speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds well to questions; demonstrates group presentation skills; participates in meetings.
  • Organizational Support - follows policies and procedures; completes administrative tasks correctly and on time; supports organization's goals and values; benefits organization through outside activities; supports affirmative action and respects diversity.
  • Planning/Organizing - prioritizes and plans work activities; uses time efficiently; plans for additional resources; sets goals and objectives; organizes or schedules other people and their tasks; develops realistic action plans.
  • Problem Solving - identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions; works well in group problem solving situations; uses reason even when dealing with emotional topics.
  • Professionalism - approaches others in a tactful manner; reacts well under pressure; treats others with respect and consideration regardless of their status or position; accepts responsibility for own actions; follows through on commitments.
  • Project Management - develops project plans; coordinates projects; communicates changes and progress; completes projects on time and budget; manages project team activities.
  • Quality - demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality.
  • Safety and Security - observes safety and security procedures; determines appropriate action beyond guidelines; reports potentially unsafe conditions; uses equipment and materials properly.
  • Teamwork - balances team and individual responsibilities; exhibits objectivity and openness to others' views; gives and welcomes feedback; contributes to building a positive team spirit; puts success of team above own interests; able to build morale and group commitments to goals and objectives; supports everyone's efforts to succeed.
  • Technical Skills - assesses own strengths and weaknesses; pursues training and development opportunities; strives to continuously build knowledge and skills; shares expertise with others.
  • Written Communication - writes clearly and informatively; edits work for spelling and grammar; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information.

PHYSICAL DEMANDS AND WORK ENVIORNMENT:

  • Travel 25% of the time which includes automobile travel with field-based sales team.
  • While performing the duties of this job, the noise level in the work environment is usually quiet.
  • Specific vision abilities required by this job include: Close vision.
  • Continuous sitting for prolonged periods.
 Apply here
Posted 8/5/2021

ASSOCIATE DIRECTOR, ETHICS & COMPLIANCE OPERATIONS - Alnylam Pharmaceutical
Location: Cambridge, MA US


Alnylam is the world's leading RNA interference (RNAi) company.

Founded in 2002, Alnylam was built upon a bold vision of turning scientific possibility into reality by harnessing the power of RNAi for human health as an innovative new class of medicines. We are a growing biopharmaceutical company with three approved medicines and a robust pipeline of investigational medicines focused in four strategic therapeutic areas: genetic medicines, cardio-metabolic diseases, infectious diseases, and central nervous system (CNS) and ocular diseases, including several in late-stage development.

Headquartered in Cambridge, Mass., Alnylam employs over 1,500 people in 19 countries and is rapidly growing globally, with additional offices in Norton, Mass., Maidenhead, U.K., Zug, Switzerland, Amsterdam, Netherlands, and Tokyo, Japan. Alnylam is proud to have been recognized as one of The Boston Globe's Top Places to Work six years in a row (2015-2020), a Great Place to Work in the U.K. and Switzerland two years in a row (2019-2020) and a Science Magazine's Top Employer two years in a row (2019-2020). Please visit www.alnylam.com for more information.

Reporting to the Senior Director, Ethics & Compliance Operations, the Associate Director will design, develop, implement, and evaluate the compliance program and monitors its operational implementation. The Associate Director will also revise the compliance program in response to the changing operational needs of the organization, with an eye toward continuous improvement and program enhancement.

The Associate Director will work closely with colleagues in the broader Ethics & Compliance team and related cross functional teams in support of the Ethics and Compliance expertise area objectives.

Responsibilities

  • Covering all the elements of an ethics and compliance program, develop and maintain infrastructure to ensure global strategies are executed consistently at regional and local levels as applicable
  • Develop and oversee control systems to prevent violations of applicable guidelines and internal policies and evaluate the efficiency of controls and improve them continuously
  • Develop and maintain policy governance infrastructure and draft, modify and implement appropriate policies and procedures to ensure compliance with applicable laws, regulations and industry codes
  • Manage and build a global compliance training plan to ensure training is assigned to appropriate job functions. Lead the planning, development, and execution of Ethics and Compliance training including but not limited to the annual training of the Alnylam Code of Business Conduct and Ethics, Corporate Compliance policies, and new hire training
  • Lead and manage the development and socialization of compliance analytics including but not limited to auditing and monitoring, training, and spend analytics.
  • Lead and manage the global auditing and monitoring programs and ensure global tracking and completion. Execute targeted auditing and monitoring as needed to assist compliance business partners.
  • Manage the compliance risk assessment process in partnership with the Senior Director, Operations and global Ethics and Compliance team.
  • Manage the reporting and presentation requirements of the function especially to Senior Management
  • Keep abreast of regulatory developments as well as evolving best practices in compliance control
  • Collaborate with corporate counsels to monitor enforcement of standards and regulations
  • Limited travel may be required
  • Other responsibilities as may be assigned from time to time in the company's discretion

Education, Experience & Skills

  • Bachelor's Degree required. Other relevant accreditations or degrees, including Juris Doctor, considered
  • Minimum of 5-10 years of ethics, compliance and/or legal experience in an organization subject to biopharmaceutical, medical device or other relevant healthcare compliance laws and regulations
  • Strong knowledge of Microsoft products, compliance support systems such as risk assessments, compliance hotlines, case management system, and experience using and developing analytics.
  • Knowledge of laws and regulations applicable to global pharmaceutical companies, including among other things, the Foreign Corrupt Practices Act, US fraud and abuse and false claims laws, IFPMA, EFPIA and PhRMA Codes on interactions with healthcare professionals.
  • Must be able to work collaboratively in a team environment on a broad range of matters with a wide variety of personnel
  • Ability to manage multiple tasks simultaneously, to work independently and manage discrete areas of responsibility with little direct supervision, and to flourish in a fast-paced and high energy environment
  • Able to thrive in a proactive ethical culture in which compliance and business objectives are mutually reinforcing; strong motivation and ability to champion a comprehensive compliance program that is integrated well with the Company's business and culture
  • Excellent organization, communication (verbal and written fluency in English required) and prioritization skills, including the ability to communicate concisely, to integrate legal and business considerations, and to provide balanced advice regarding risks

Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.

 Apply here
Posted 8/3/2021

DIRECTOR, COMPLIANCE - AUDITING & MONITORING - Idorsia
Location: Philadelphia Area - Radnor, PA, PA, US


The purpose of Idorsia is to discover, develop and bring more, innovative medicines to patients. We have more ideas; we see more opportunities and we want to help more patients. In order to achieve this, we will develop Idorsia into a leading biopharmaceutical company, with a strong scientific core.

Headquartered near Basel, Switzerland, the US Commercial Operations & Clinical Development teams are based near Philadelphia, Pennsylvania. Idorsia is committed to meet the changing needs of healthcare professionals, patients and their families. The core of what we do is to bring creative solutions to the market based on our science and data.

The Director, US Compliance Auditing and Monitoring is responsible for identifying current Compliance risk areas and establishing auditing and monitoring approaches to evaluate company adherence to US regulations and Idorsia Policies and Procedures. This role will be expected to use technology, analytics and traditional live monitoring and records review activities to help Idorsia's US business identify and appropriately remediate potential concerns. These activities will include, but not be limited to, planned risk assessment and subsequent monitoring/auditing activities as well as ad hoc assessments and investigations necessitated because of helpline communications or monitoring/auditing finding.

Key Responsibilities:

  • Conducts live field monitoring of Commercial and Medical Affairs activities.
  • Conducts transactional monitoring of records and systems including but not limited to: patient assistance programs, arrangements and interactions with Independent Charity PAPs, expense reporting, medical information requests, educational grants and other external funding requests and consulting and advisory engagements with healthcare providers.
  • Prepares reports, presentations, and dashboards for numerous audiences, including Idorsia Leadership and the Idorsia Compliance Committee, that summarize monitoring and auditing findings and remediation.
  • Develops and implements an appropriately scaled risk assessment and management process and prioritizes monitoring activities and mitigation plans in accordance with that process.
  • Oversees the remediation and corrective action process for the Compliance team.
  • Conducts ad-hoc monitoring and auditing as necessitated by investigations carried out by the Compliance Department.
  • Develops appropriate data analytics and use of innovative technology to expand and advance monitoring capabilities.
  • Contributes as needed to the preparation of Government reporting, including reports required under the Open Payments law and state law monitoring and reporting.

Qualifications:

  • Minimum of 10 years of healthcare compliance monitoring and auditing experience with a pharmaceutical/biopharmaceutical company or within the life sciences industry.
  • Demonstrated knowledge and understanding of the Anti-Kickback Statute, False Claims Act, Food and Drug Administration (FDA) rules and regulations regarding the promotion of pharmaceuticals, HIPAA, Open Payments, and relevant industry guidance, specifically the PhRMA Code on Interactions with Healthcare Professionals.
  • Ability to manage multiple projects to completion on-time, meeting internal and external deliverables with high degree of accuracy.
  • Ability to interact with Idorsia employees at all levels of the organization.
  • Team player with strong interpersonal skills.
  • Strong oral and written communication skills.
  • Ability to work collaboratively and independently as the circumstances require.
  • Self-motivated and detail oriented.
  • Highest level of ethics and personal integrity.
  • Ability to travel domestically up to 25%.

At Idorsia, we harness the power of difference, authenticity and inclusion to achieve business success. We are committed to fostering respect, fairness and equal opportunities for all job applicants and all our employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against based on disability.

Please be informed that if you are selected for this position, your employment will be subject to a pre-employment background screening process, of which you will be informed in greater detail in due course.

Idorsia operates a strictly controlled list of preferred recruitment partners. For those partners who have no valid, signed Master Service Agreement in place with Idorsia, please note that all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of Idorsia Pharmaceuticals (including any of its subsidiaries, affiliates or related companies) are considered the property of Idorsia Pharmaceuticals and are not subject to payment of any form of introduction, placement or referral fees.

 Apply here
Posted 7/22/2021

ASSOCIATE DIRECTOR, HCC MONITORING & AUDITING - Insmed
Location: Bridgewater, NJ, US


Company Description
About Insmed:
Insmed is a growing global biopharmaceutical company powered by our purpose to deliver life-altering therapies to small patient populations experiencing big health problems. Our most valuable resource is our employees, and a patients-first mentality guides everything we do. Today, we are building a world-class team of talented individuals who are willing to challenge the status quo, solve problems, and work collaboratively and with a sense of urgency.

Come join us if you are ready to roll up your sleeves and be recognized for your efforts while working alongside team members who share your passion for serving patients and their families.

Overview
About the Role:
Reporting to the Director, Risk Assessment, Monitoring and Auditing, this role will serve as the lead for the Healthcare Compliance Auditing, Monitoring and Risk Management team. The incumbent will guide and direct healthcare compliance auditing and monitoring life cycle, from conducting risk assessment through creation of the annual monitoring and auditing plan through conduct of those activities and creating and assessing results and metrics. This role will be based at our Bridgewater, New Jersey headquarters location.

This is a non-supervisory position. This position may need to oversee and supervise vendors who conduct monitoring and auditing on Insmed's behalf.

Responsibilities
Additional representative responsibilities will include, but not necessarily be limited to, the following:

  • Conduct healthcare compliance monitoring include live activities in the US (e.g. field rides, speaker programs, congresses) and records review globally (e.g. travel & expense, healthcare professional engagements)
  • Conduct healthcare compliance audits in the US (e.g. patient services, speaker's bureau) and pertaining to global functions (e.g. grants, medical information, publications)
  • Conduct audits of third-party vendors as assigned
  • Effectively partner with the business to communication findings or observations
  • Track remediation for all monitoring and auditing activities
  • Support the Director to capture and report metrics in a meaningful and engaging manner that helps the Global Compliance Leadership Team and other senior leaders understand Insmed's global compliance risk profile
  • Support annual risk assessment and annual monitoring and auditing plan development
  • Develop and maintain ongoing relationships with EMEA and Japan Compliance Officers and across various functions, as applicable.

Qualifications
About you:

  • Bachelor's degree required
  • Pharmaceutical compliance certification is a plus
  • At least 7 years' experience in healthcare compliance monitoring or auditing for a pharmaceutical or biotech company
  • Knowledge of US compliance regulations, laws and standards
  • High level of familiarity with broad range of compliance risk areas, relating to business practices of a U.S. business
  • Ability to quickly learn global compliance regulations, laws and standards to partners with Compliance Officers outside the US
  • Experience in conducting healthcare compliance monitoring (live field rides, live speaker programs, records reviews)
  • Experience in conducting healthcare compliance audits
  • Independently produce accurate reports and articulate correspondence.
  • Able to manage varying and high workload and sets priorities accordingly to support Director efficiently and in a solution-oriented manner
  • Produces high quality work with minimal oversight from Director
  • Possesses a 'can-do' attitude and the ability to work independently yet collaboratively with internal business partners
  • Must have excellent communication skills (verbal and written)
  • Must have strong writing skills
  • Highly organized with a strong attention to detail, clarity, accuracy, and conciseness
  • Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook)

Additional Information
Travel Requirements:

  • Domestic travel required (10-20%). Some international travel could occur in rare instances.
  • Insmed is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability or any other characteristics protected by applicable federal, state or local law.
  • Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.
  • Please note that we review every submission and we will keep all submissions on file for six months. Insmed is an Equal Opportunity Employer.
 Apply here
Posted 7/13/2021