The Pharmaceutical Compliance Forum

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EMPLOYMENT OPPORTUNITIES

 

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.


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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.
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Posted 7/13/2021