The Pharmaceutical Compliance Forum

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EMPLOYMENT OPPORTUNITIES

 

COMPLIANCE - HCP ENGAGEMENT LEAD - PHARMA - Shionogi Inc.
Location: Florham Park, NJ US


The HCP Engagement Lead manages Compliance processes related to evaluation and execution of Healthcare Professional (HCP) engagements and interactions with Healthcare Organizations (HCOs). Will support the needs of business owners while simultaneously ensuring potential risks are evaluated and mitigated appropriately. Will also serve as a core member of the Compliance Team and represent Compliance on committees related to HCP/HCO activities.

RESPONSIBILITIES

  • Manage the Compliance Review Committee (CRC) process, which has corporate responsibility for ensuring appropriate interactions with HCPs and HCOs;
  • Conduct substantive review of all requests for engagement of HCPs and interactions with HCOs that are submitted to Shionogi's CRC. Review includes, but is not limited to, an evaluation of the following parameters: needs assessments, activity details, HCP attributes and credentialing, activity venue (if applicable), Shionogi participants, accounting for deliverables, etc.;
  • Work closely with CRC Coordinator to ensure that requests are reviewed in a timely manner;
  • Liaise with business owners to ensure understanding of business needs and project details;
  • Conduct HCP licensure checks, debarment screenings, exclusion screenings, and other diligence, as required, relevant to HCP engagements;
  • Review and apply output from Medical Affairs HCP credentialing process. Escalate exception requests to Vice President, Compliance, as required;
  • Manage the process for determination of Shionogi's FMV rates. Identify and assign appropriate Fair Market Value (FMV) rates for HCP engagements utilizing Shionogi's FMV Rate Card;
  • Populate HCP contracting templates as required by engagement type;
  • Collaborate with Shionogi Legal on HCP/HCO requests for contract modifications;
  • Serve as Compliance representative during Medical Review Committee (MRC) meetings, as needed (Compliance is an ad-hoc member of the MRC);
  • Liaise with colleagues in Japan and Europe on multi-regional projects related to HCP engagement. Drive consistency and optimization of processes for cross-border HCP engagements; and
  • Support the VP Compliance in additional activities, as requested, which may include but not limited to the following: periodic monitoring and auditing of HCP activities; internal investigations related to HCP/HCOs; inquiries related to HCP spend data reporting (e.g., Sunshine Act review/disputes).

REQUIREMENTS

  • Bachelor's Degree required; additional paralegal or legal training preferred.
  • 5 plus years of Compliance and/or Legal Department work experience in a regulated industry such as: Pharmaceutical, Medical Device and /or other Life Science industry.
  • Able to draft contractual documents and have familiarity with related laws.
  • Self-motivated, proactive, and able to manage tight deadlines and/or multiple projects with limited supervision.
  • Strong organizational, analytical and interpersonal skills.
  • Strong verbal and written skills; must be clear and concise with individuals and groups - internally and externally.
  • Demonstrated success as a subject matter expert with regard to related compliance issues.
  • Familiarity with government databases is preferred.
  • Must be detail-oriented and show comfort as both a team player and an individual contributor.
  • Should be solutions-oriented in approach to decision making.
  • Travel is estimated not to exceed 15%.
  • Proficient in MS Word, MS Excel, MS PowerPoint, Adobe Acrobat and technology in general.
  • Ability to operate a computer keyboard, and to view video display terminal images up to four (4) hours at a time.

To be considered for this position, you must apply and meet the requirements of this opportunity. We look forward to reviewing your resume & qualifications.

DISCLAIMER
The job description is not designed to cover or contain a comprehensive listing of requirements, duties or responsibilities that are required of the employee. Other requirements, duties and responsibilities may change or be assigned at any time with or without notice.

EEO

Shionogi Inc. is an equal opportunity/affirmative action employer.

All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law. It is the policy of Shionogi Inc. to undertake affirmative action in compliance with all federal, state, and local requirements to recruit a diverse pool of applicants and to ensure that our employment practices are, in fact, non-discriminatory.

Interested parties can go to https://www.shionogi.com/us/en/careers.html to learn more and apply for the position.
 Apply here
Posted 4/13/2021

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


Overview
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, U.S. Ethics and Compliance, the Associate Director will lead the design, implementation, and enhancement of an effective ethics and compliance program for Alnylam's US Business. The Associate Director will work closely with colleagues in the broader Ethics & Compliance team, and with regional Legal and business colleagues to sustain Alnylam's strong ethical culture and ensure employee adherence to the Company's Code of Conduct and related rules, policies, and procedures.

Summary of Key Responsibilities

  • Employ soft leadership skills with employees and leadership to maintain and enhance throughout the organization a strong culture of ethics and compliance, including personal accountability at all levels in the organization with a spirit of partnership and positive problem solving
  • Assist Compliance Leadership Team with efforts to evolve the compliance program within the US Region to ensure it is consistent with Alnylam's values and principles, that it is fit for purpose and complies with applicable requirements
  • Draft and/or update appropriate policies to ensure compliance with applicable laws, regulations and industry codes and alignment with global policies
  • Prepare and deliver training and education to ensure understanding of employee responsibilities and ethics and compliance issues, as well as related policies and procedures
  • Execute routine and risk-based monitoring and auditing of relevant US Business activities and related policies and procedures; identify potential areas of compliance vulnerability and risk; ensure corrective action plans are implemented when required; and generate reports on monitoring, auditing and risk assessment for the US Business
  • Maintain (and in some cases create) records management and documentation systems instrumental to a successful Compliance program
  • We are a lean organization - the ability (and willingness) to move between routine administrative and more senior-level work is a must
  • Position is based in Cambridge. Travel required once Covid restrictions are lifted
  • Other responsibilities as may be assigned from time to time in the company's discretion

Qualifications

  • Bachelor's Degree required. Other relevant accreditations a plus
  • Minimum of 8 years ethics, compliance and/or related legal experience in an organization subject to US biopharmaceutical, medical device or other relevant healthcare compliance laws and regulations
  • Deep knowledge of (and experience with) laws and regulations applicable to global pharmaceutical companies, including US fraud and abuse and false claims laws, and PhRMA Code on Interactions with Healthcare Professionals
  • The ideal candidate will have Compliance Business Partner Experience
  • Must be able to work collaboratively in a team environment on a broad range of matters with a wide variety of company personnel, including physicians, scientists and individuals of different nationalities - you will lead the way to appropriate risk decisions by combining your deep knowledge of compliance, your soft leadership skills, and extraordinary tact
  • Ability to lead multiple projects simultaneously, to work independently and manage discrete areas of responsibility without direct supervision, and to flourish in a fast-paced and high energy environment. You must be willing to flex into new areas with enthusiasm and sound judgment
  • 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 with senior leaders, to integrate legal and business considerations, and to provide balanced advice regarding risks to all levels of the organization from junior marketers to SVPs
  • Absolute willingness to treat role as a growth opportunity

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

 Apply here
Posted 4/9/2021

COMPLIANCE MANAGER - Otsuka
Location: Princeton, NJ US


Job Summary
Compliance Manager will report to Compliance Counsel in Ethics & Compliance (E&C) to support the effective implementation of the company's comprehensive compliance program.

Job Description

  • Work with Compliance Counsel and the compliance analytics team to build out a robust analytics tool to assess compliance risk. This would include reviewing, interpreting, and creating dashboards based on company data to allow for more robust compliance analytics and reporting capabilities.
  • Assist Compliance Counsel in providing risk mitigation guidance and support to CNS franchise and Commercial Operations business teams.
  • Work directly with sales management to address potential issues identified during call note review, email review and/or expense report reviews.
  • Work closely with the E&C training department to develop relevant compliance content and guidance documents for field-based employees and others.
  • Provide compliance support to Sales Operations including drafting field communications in furtherance of compliance objectives.
  • Monitor state laws and regulations related to detailer licensing and sales representative registration requirements and ensure company compliance with the same.
  • Provide live monitoring support for field-based activities.
  • Provide additional support to the E&C team as needed.

Qualifications
Required

  • Bachelor's degree required
  • At least 3 years of substantive corporate compliance experience.
  • In-depth understanding of US healthcare industry laws and regulations.
  • Strong interpersonal, writing, communication, organizational, project management and presentation skills.
  • Experience in handling confidential and sensitive situations or information with an ability to exercise a high degree of judgment and discretion.
  • Up to 20% travel based on business needs.

Preferred

  • Juris Doctorate degree
  • Data analytics background

Come discover more about Otsuka and our benefit offerings;
https://www.otsuka-us.com/careers-join-otsuka

Disclaimer: This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.

 Apply here
Posted 4/6/2021

SR. COMPLIANCE COUNSEL - Neurocrine Biosciences
Location: San Diego, CA US


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

What We Do:
Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company with 28 years of experience discovering and developing life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis* and uterine fibroids*, with three pivotal and five mid-stage clinical programs in multiple therapeutic areas. Headquartered in San Diego, Neurocrine Biosciences specializes in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. (*in collaboration with AbbVie)

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

Your Contributions (include, but are not limited to):

  • Provide clear and sound compliance advice to key stakeholders, executive management and employees at Neurocrine, consistent with applicable laws, regulations and Neurocrine policies
  • Act as advisor and provide compliance input and expertise into business decisions, including development of solutions-orientated risk mitigation strategies
  • Provide proactive risk assessments regarding the compliance/ethics program and provide recommendations for updates/changes to the program or business operations as needed
  • Oversee compliance investigations regarding allegations of potential violations of law, company policy and/or ethical standards, prepare recommendations based on results of the investigations and implement corrective actions
  • Proactively conduct monitoring and auditing to ensure compliance with applicable laws, regulations and Neurocrine policies, including field rides, speaker programs and advisory boards
  • Assess compliance training needs, develop and deliver effective and creative training, including written materials, computer-based training and live presentations
  • Perform other duties as assigned/requested

Requirements:

  • BA/BS Degree and Juris Doctorate Degree and 10 years of legal and/or compliance experience, including a minimum of 3 years with the biotech/pharmaceutical or medical device industry
  • An active license to practice law in any state preferred
  • Ability to independently identify, analyze and render legal advice on complex issues
  • Ability to deliver clear, concise and accurate advice, including the appropriate level of detail and anticipation of follow-up questions
  • Ability to build consensus with diverse stakeholders and third parties and form strong, collaborative working relationships with clients
  • Expertise with respect to corporate compliance is required
  • Recognized as external expert in a strategic job function
  • Requires broad and comprehensive expertise in leading-edge theories and techniques within a strategic job function
  • Applies ingenuity and creativity to problem analysis and resolution in complicated and/or novel situations
  • Influences internal/external business and/or industry issues that have an impact on Neurocrine
  • Ability to drive strategic direction into tactical plans
  • Ability to lead multiple teams
  • Strong leadership, mentoring skills and abilities typically supervises lower levels and/or leads indirect teams
  • Exceptional communications, problem-solving, analytical thinking, influencing skills
  • Sets broader picture and longer-term vision for department
  • Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
  • Excellent project leadership skills
  • Research skills
  • Decision-making and planning skills
  • Organizational skills

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

Please apply directly via www.neurocrine.com
 Apply here
Posted 4/2/2021

DIRECTOR, USBU ETHICS & COMPLIANCE ADVISORY - TAKEDA
Location: Boston, MA US


Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as the Director, USBU Ethics & Compliance Advisory in our Boston MA, office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission.

As the Director, U. S. Business Unit Ethics & Compliance Advisory working on the Ethics & Compliance Team,

POSITION OBJECTIVES:
Ethics & Compliance (E&C) focuses on what the organization needs by ensuring:

  • Ethical behavior plays a fundamental role in risk mitigation
  • Being a forward-thinking leader in risk identification and mitigation
  • Building a modern function supporting achievement of Takeda's Vision 2025
    E&C will respond rapidly to changing environment and business needs, it is close to the market, and encourages ethical behavior in line with Takeda's values. By working in an agile manner E&C ensures the balance between stable structures, governance, processes and systems, and dynamic approaches to delivering innovative solutions to appropriately manage our risks.

E&C commits to:

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

POSITION ACCOUNTABILITIES:

  • Lead implementation of E&C strategy for USBU by influencing senior management and other stakeholders to adhere to existing ethics & compliance principles and change behavior to new trends that Takeda establishes as best practice.
  • Maintains and further strengthens business expertise and nurtures cross functional relationships to enable a proactive, holistic and cross functional approach to risk identification.
  • Works closely with senior leaders and cross functional partners to align on, and implement, ethics & compliance controls to proactively manage identified risks.
  • Develops programs that empower leaders to seamlessly integrate ethics & compliance principles into their direction to, and leadership of, their teams.
  • Provide Ethics & Compliance guidance related to strategic activities, such as brand planning, Incentive Compensation structures, and organizational design.
  • Thinks beyond his/her assigned therapeutic area to anticipate the potential impact of his/her advice on other areas of the company and proactively collaborates and communicates with the relevant stakeholders to manage this impact.
  • Demonstrates leadership within the USBU E&C organization, such as informally mentoring other team members and proactively educating other team members on relevant topics.
  • Provide leadership and guidance to senior management, sales force and home office employees/contractors, and affiliates on interpretation of Code of Conduct, Compliance Policies, and relevant SOPs, guidance documents, and other E&C program requirements.
  • Deliver high-impact presentations to promote awareness and adherence to Ethics & Compliance principles.
  • Create and manage the content, logistics, and execution of various Ethics & Compliance communication initiatives.
  • Develop materials for USBU Compliance Committee meetings including external bench-marking, internal compliance metrics - dashboards, and compliance program vision. Present to USBU President and Executive staff at USBU Compliance Committee meetings where required.
  • Create programs for new ways to increase alignment with, Ethics & Compliance principles and Takeda Values through visibility and engagement with field-based resources and other stakeholders
  • Evaluate potential company activities consistent with company process (or manage team members responsible for this review), such as commercial advisory board submissions, fair market value requests, medical education, HCP and Patient engagement and potential conflicts of interest.
  • Periodically review and adjust policies and procedures to align with current Takeda Legal feedback as well as Compliance team input
  • Identify and analyze external trends and drive into organization where needed.
  • Perform periodic reviews of US & USBU Policies and Procedures to ensure they are consistent with Takeda Values, OIG regulatory guidance, PhRMA Code requirements and other applicable laws, regulations and internal policies and procedures
  • External facing - Drive USBU Advisory engagement with evolving Ethics & Compliance trends (PhRMA, OIG, DOJ)
  • Negotiate to create solutions in harmony with leadership and business needs.
  • Lead, develop and implement live training programs and strategies designed to support current and planned USBU business models (E.g. - sales training)
  • Partner with the business as well as any third-party vendor to live monitor USBU business unit activities, such as field rides, speaker programs and advisory boards.
  • Research and respond to compliance hotline/helpline questions on an as-needed basis.

CAPABILITIES

  • Respected expert and advisor to senior management of the BU who influences and drives the Ethics & Compliance agenda for the BU
  • Exceptional skills to transform ideas into conversations and materials that resonate (presentations, written documents, email, etc.)
  • Consistently demonstrates the ability to deliver results both through self and others
  • Able to work and deliver on deadlines while managing multiple projects and priorities effectively
  • Works cross-functionally / collaborates / manages matrix - Strong leadership skills, including the ability to lead change efforts through effective communication and persuasion
  • Strong customer service skills and ability to demonstrate executive presence while interacting with all levels of management and stakeholders.
  • Demonstrated ability to read, analyze, and interpret business and regulatory information and legal advice

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

  • 10-14 years of legal, compliance or commercial experience, of which at least 8 years in the healthcare or pharmaceutical industry;
  • Bachelor's degree required; JD or relevant advanced degree preferred
  • Strong understanding of state and federal health care laws/regulations
  • Extensive experience with laws, regulations and industry guidance that affect the pharmaceutical industry including, but not limited to, OIG and PhRMA guidelines, healthcare standard operating procedures, anti-bribery laws, and state price reporting statute

WHAT TAKEDA CAN OFFER YOU:

  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement Company match of charitable contributions
  • Health & Wellness programs including onsite flu shots and health screenings
  • Generous time off for vacation and the option to purchase additional vacation days
  • Community Outreach Programs

Empowering Our People to Shine
Discover more at takedajobs.com
No Phone Calls or Recruiters Please.
#LI- AS2

This job posting excludes CO applicants

 Apply here
Posted 3/8/2021

MANAGER, HEALTHCARE COMPLIANCE - ZS Associates
Location: Princeton, NJ/ Flexible Remote East Coast US


Brief Role Description:
The individual in this role will support the Global Head of Risk & Compliance to unlock a new level of innovation, performance, and patient outcomes for clients by better navigating risk. This role will be important to help develop capabilities and service offerings to advance ZS as a leader in delivering strategic risk management solutions for clients by: (1) Integrating risk management into design of solutions; (2) Targeting risk and resources based on compliance insights from advanced analytics; and (3) Driving ethical culture.

What are the top priorities for the position?

  • Partner with practices to develop thought leadership and offerings that blend the best of our thinking on commercial/medical issues with a deep understanding of compliance requirements so that compliance is seen as a positive enabler of commercial/medical innovation
  • Partner with client teams to identify project and transformation opportunities where bringing an integrated perspective on compliance will create a big impact
  • Leverage personal network and collaborate with client teams to drive discussions with Sr Compliance leads at clients to understand and ultimately shape their agenda
  • Build on our existing offerings in compliance and sunshine analytics/reporting to bring more innovation and deeper domain expertise

How will success be measured for this role?

  • Client team engagement and feedback
  • New and/or improved relationships
  • Compelling offerings with strong feedback from our clients
  • Direct revenues for compliance work sold and delivered and revenue touched as an indicator of broader enablement success

What expectations would we have?

  • Deep compliance and risk management expertise. Full understanding of regulatory requirements and best practice approaches among pharmaceutical companies.
  • Personal network of compliance professionals across industry and government to help stay current on emerging developments and priorities
  • Deep knowledge of US healthcare system and trends
  • Be able to understand and identify linkages with our existing offerings (given space and time to learn)
  • Be very good at presenting / selling an idea

What expectations would we not have?

  • We would not expect this individual to work in isolation.

What skills are we looking for?

Education:

  • Law or other advanced degree relevant to possessing deep domain knowledge in Healthcare Compliance

Required Skills:

  • 10+ years of experience in Healthcare Compliance, ideally with direct experience in both govt. and industry
  • Prior management consulting experience
  • Prior leadership experience, with a history of successfully building new teams
  • Demonstrated ability to quickly assimilate new knowledge
  • Executive-level presence and communication
  • Demonstrated ability to deliver compelling conference presentations and white-papers
  • A willingness to travel to meet client needs
  • Demonstrated ability to develop, maintain and grow relationships

Key Responsibilities would include:

  • Drive efforts to provide solutions to our clients
  • Drive the effort to enhance existing offerings and develop new offerings
  • Engage other practice areas to ensure they have support as needed
  • Provide thought leadership and innovation within projects
  • Manage projects and client relationships
  • Drive business and strategy development
  • Direct multiple projects simultaneously, honing analytic and project management skills
  • Motivate, coach and serve as a role model for project team members

 Apply here
Posted 3/4/2021

SENIOR MANAGER, ETHICS & COMPLIANCE, US - Alnylam
Location: Cambridge, MA US


Overview
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, U.S. Ethics and Compliance, the Senior Manager will support the design, implementation, and enhancement of an effective ethics and compliance program for Alnylam's US Business. The Senior Manager will work closely with colleagues in the broader Ethics & Compliance team, and with regional Legal and business colleagues to sustain Alnylam's strong ethical culture and ensure employee adherence to the Company's Code of Conduct and related rules, policies, and procedures.

Summary of Key Responsibilities

  • Partner with employees and leadership to maintain and further develop throughout the organization a strong culture of ethics and compliance, including personal accountability at all levels in the organization with a spirit of partnership and positive problem solving
  • Assist Compliance Leadership Team with efforts to evolve the compliance program within the US Region to ensure that it is consistent with the values and principles of the organization, fit for purpose and complies with applicable requirements
  • Draft and/or update appropriate policies to ensure compliance with applicable laws, regulations and industry codes and alignment with global policies
  • Prepare and deliver training and education to ensure understanding of employee responsibilities and ethics and compliance issues, as well as related policies and procedures
  • Execute routine and risk-based monitoring and auditing of relevant US Business activities and related policies and procedures; identify potential areas of compliance vulnerability and risk; assist in and oversee the implementation of corrective action plans as necessary; and generate reports on monitoring, auditing and risk assessment for the US Business
  • Maintain (and in some cases create) records management and documentation systems instrumental to a successful Compliance program
  • Position is based in Cambridge. Travel required once Covid restrictions are lifted
  • Other responsibilities as may be assigned from time to time in the company's discretion

Qualifications

  • Bachelor's Degree required. Other relevant accreditations a plus
  • Minimum of 7 years of ethics, compliance and/or legal experience in an organization subject to US biopharmaceutical, medical device or other relevant healthcare compliance laws and regulations
  • Knowledge of laws and regulations applicable to global pharmaceutical companies, including US fraud and abuse and false claims laws, and PhRMA Code 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 company personnel, including physicians, scientists and individuals of different nationalities
  • 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. You must be willing to flex into new areas with enthusiasm and sound judgment
  • 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
  • Absolute willingness to treat role as a growth opportunity. The successful candidate should be comfortable with a career development tract that will lead to Compliance Business Partner opportunities and beyond

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

 Apply here
Posted 2/13/2021