The Pharmaceutical Compliance Forum

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EMPLOYMENT OPPORTUNITIES

 

DIRECTOR, COMPLIANCE OPERATIONS - Boehringer Ingelheim
Location: Ridgefield, CT US
Relocation assistance is available


Description:
Accountable for leading the U.S.-wide Compliance Operations' key functions and personnel overseeing: Transparency & Disclosure (T&D), Government Reporting; Anti-Bribery Anti-Corruption (ABAC) program; Third-Party Due Diligence; FMV evaluations; the BI Global 'Center of Excellence' for cross-border spend reporting; Compliance Systems Validations; Compliance Analytics; Compliance Data Quality Center; and serves as the U.S. Healthcare Compliance (HCC) Officer. Responsible for the validation of all Compliance Operations' reporting tools and interfaces. Leads a team of Compliance professionals responsible for developing, implementing and maintaining effective Compliance Program elements for ABAC, FMV, T&D, Government Reporting, Training, Due Diligence, Analytics, etc., that is data-led and risk-based. Works collaboratively and supports all other Compliance functions, serves as Compliance Business Partner to HP Operations, and advises Corporate Compliance Operations.

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

Duties & Responsibilities:

  • Accountable for the overall strategy, governance and execution of the U.S. Transparency & Disclosure (T&D) Program, including without limitation, the timely and accurate submissions of all U.S. entities' Federal, State, local and cross-border reporting requirements and certifications. Tracks updates for reporting requirements and new laws; designs and implements T&D strategy for complying with all legal requirements for spend capture and disclosure. Develops, implements, monitors and ensures validation of local and cross-border Disclosure Program and systems,  and reviews, approves and serves as escalation point for cross-border spend. Drafts and maintains policies and procedures. Influences and advises Corporate on global T&D Program. As the U.S. Healthcare Compliance Officer, responsible for localizing all Corporate Compliance Healthcare policies, programs or directives, as well as overseeing (including reviewing, approving and maintaining a database for) all (global) cross-border engagements with U.S. HCPs, HCOs, Patients and Patient Organizations. Reports quarterly on KPIs, trends and risks to U.S. Board, U.S. Compliance Committee and BIPI Compliance Advisory Committee. Prepares and oversees annual HHS/CMS certifications for VP, Chief Ethics & Compliance Officer.
  • Directs and oversees U.S.-wide Fair Market Value (FMV) program, including without limitation, the evaluation of HCPs, others as applicable and services provided to customer organizations, monitoring and assessment of engagement process, the annual bolus screening of HCPs, and periodic updates of the FMV rate-card data. Serves as escalation point and decision-maker for re-evaluations.
  • Accountable for strategy, execution and continuous evolution U.S.-wide Anti-bribery/Anti-corruption (ABAC) program, including without limitation, implementation of controls for FCPA and other global anti-corruption regulations, third-party due diligence and screening program, Compliance training, auditing and data analytics (including oversight of an off-shore data quality-control and analytics group).
  • Designs, implements and routinely enhances analytics functionality for Compliance Operations.
  • Lead (recruit, hire, coach, develop, motivate, manage and monitor performance) and directly manage a staff of approximately 4-6 dedicated Compliance professionals; Creates and maintains a performance-based team culture with clear accountability and a sense of accountability for achieving results. Management includes goal setting, performance evaluations and compensation decisions, hiring, and coordinating with stakeholders on the performance and expectations of the groups.

Requirements:

  • Bachelors degree from an accredited institution.
  • Masters degree (e.g. MBA, MSc) in Business Administration and/or Doctoral degree (e.g. PhD or LLM) in Law preferred.
  • Industry certification (e.g. HCCA or SCCE) also preferred.
  • History of successful performance in pharmaceutical Compliance leadership role(s).
  • At least 8 - 15 years of experience in Compliance Operations functions, e.g., T&D, ABAC, FMV, process- and system implementation for government reporting, data-capture and spend-reporting systems;
  • Knowledge and demonstrated experience in data analytics, CRM systems and aggregate reporting systems.
  • Pragmatic experience and functional knowledge of data analytics.
  • Demonstrated experience leading teams / managing groups (with strong preference for experience of managing groups or projects of significant risk, scale or complexity).
  • Substantial business, legal and regulatory knowledge and experience in pharmaceutical industry, including AKS, FCA, Fraud & Abuse laws, FCPA, PhRMA Code, etc.
  • Strong interpersonal, management and influencing skills and experience;
  • Strong results-orientation.
  • Proven ability to lead and influence outside scope of authority.
  • Must possess sound professional judgment, the ability to timely take "smart risks" based upon incomplete information, and serve as a "player/coach" in personally helping to ensure all responsibilities within Compliance Operations are timely achieved.

Eligibility Requirements:

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

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

Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health.

Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

Candidates need to use the following link to apply for the role:
 Job Description - Director, Compliance Operations (211291) (taleo.net)

Posted 5/7/2021

DIR., ETHICS & COMPLIANCE - Purdue Pharma L.P.
Department: Ethics & Compliance
Location: Stamford, CT US
Position Reports to: VP, Chief Compliance Officer


Job Summary
Serve as a leader in the ethics and compliance program for Purdue and its subsidiaries, with primary responsibility for auditing and monitoring, continuously improving compliance reporting systems, and, directing the Company's Enterprise Risk Management (ERM) process. Responsible for leadership of ethics and compliance activities within portions of Commercial, Medical, Technical Operations, and R&D business areas, providing advice to allow individuals in these areas to operate within full compliance of laws, regulations, and guidance. Provide strategic direction and partnership to the business, advising on risk and assessing initiatives for full compliance and integrity.

Primary Responsibilities

  • Serve as a business partner, providing ethics and compliance guidance to various business units including but not limited to Commercial, Medical, Technical Operations, and R&D.
  • Direct and improve the Company's Enterprise Risk Management function.
  • Develop and execute an annual Monitoring Plan and provide input on/conduct related audits. Conduct and/or collaborate on audits and assessments and establish and oversee monitoring systems within the ambit of the Purdue ethics and compliance program. Analyze and present findings of same.
  • Direct Purdue's Fair Market Value (FMV) process.
  • Develop Standard Operating Procedures (SOPs) and Working Practices Documents (WPDs), as needed, both for Ethics & Compliance Department and other functions, and assist in implementation of training programs related to same. Monitor internal compliance with relevant SOPs and/or WPDs.
  • Serve as subject matter expert on privacy matters.
  • Conduct investigations, as needed.
  • Conduct compliance-related diligence activities for product/company development activity, as needed.
  • Participate in industry ethics and compliance and other leadership roles for benchmarking and professional development.
  • Oversee staff participating in above-outlined functions.
  • Stay current on ethics and compliance issues/hot topics, as well as industry trends, best practices, federal and state guidances, etc.

Education and Experience Requirements

  • Bachelor's Degree required. Advanced degree a plus.
  • At least 10 years relevant compliance, legal, or other relevant experience, with a minimum of four years of pharmaceutical or healthcare legal or compliance experience required; relevant advanced degrees are desirable and may count toward experience.
  • Demonstrated leadership skills, together with experience supervising others, as well as interacting with all levels of management.

Necessary Knowledge, Skills, and Abilities

  • Able to gain the confidence and trust of others through integrity, honesty and authenticity
  • Builds partnerships and works collaboratively with diverse teams to meet shared objectives
  • Excellent written and verbal communication skills; ability to convey information effectively to a wide range of audiences; comfortable with public speaking and presentations
  • Strong leadership and interpersonal skills; ability to collaborate with senior management, leadership, employees, government officials and external audiences to develop and maintain good working relationships
  • Consistently achieves results even under difficult circumstances

Supervisory Responsibilities (if Applicable)
N/A
 Apply here
Posted 5/5/2021

ASSOCIATE DIRECTOR, COMPLIANCE BUSINESS PARTNER I - RESEARCH, DEVELOPMENT & MEDICINE - Boehringer Ingelheim
Location: Ridgefield, CT US
Relocation assistance is available


Description:
This role will provide medical compliance business partner support for multiple specialty care therapeutic areas, multiple medical departments (including, but not limited to, Clinical Operations and Pharmacovigilance) and help facilitate BI's policies and procedure process. To assist in the development, implementation, and continuous improvement of an effective compliance program for all business activities within Research, Development & Medicine (RD&M). To support the risk assessment and analysis process to continuously evaluate risk areas and priorities to guide new Compliance efforts. To act as a business partner to RD&M Departments to provide assistance and advice on daily operations and ensure appropriate compliance controls and training, as well as investigations of non-compliant activity and corrective action for identified business activities. To work closely with other teams within the Ethics and Compliance Department to ensure consistent application and implementation of identified compliance controls, training, monitoring, and auditing.

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

Duties & Responsibilities:

  • Participates in strategic planning for applicable organizational activities with the goal of providing compliance expertise and advice to ensure planning is efficient and considers compliance issues up-front. Also provides day-to-day support, advice and problem-solving expertise to applicable businesses to ensure business operations are conducted in full compliance with all relevant policies and procedures. Develops resources for applicable business areas, as needed, to help meet their respective compliance business needs. Monitors the external environment and recommends improvements to the company's compliance program based on identified industry best practices.
  • Provides compliance expertise and guidance to RD&M business partners to enable decision-making that stays within ethical boundaries while still optimizing business performance. Acts as a liaison with BI GmbH business and compliance colleagues to influence the conduct of global activities that implicate US laws and regulations.
  • Assesses training needs for business groups, provides input into training plans, and collaborates with appropriate individuals to develop training content, acting as subject matter expert for business area. Facilitates and delivers training as appropriate. Educates business groups in a way that closes knowledge gaps and addresses larger trends.
  • Collaborates with personnel responsible for auditing plans to execute the auditing plan, including developing and executing action plans for identified CAPAs (Corrective and Preventative Actions) and monitoring established controls after implementation. Analyzes auditing results to recommend improvements in Compliance or business operations. Supports other activities of RD&M, including risk assessment and strategic planning, training and communication, health care provider interaction initiatives (i.e., implementation of fair market value, Sunshine Act requirements), and development of ethical business culture.
  • Collaborate with internal OEC team members to identify areas of compliance risk in respective business areas, including but not limited to topics of Transparency & Disclosure, CIA, Anti-Bribery and Anti-Corruption (ABAC), and compliance operations, and ensure that systems, policies, procedures, training and other resources are coordinated to mitigate risk to impacted business areas. Effectively communicate and collaborate with OEC team members to ensure business and compliance objectives are met. Assist business in remediating findings from investigations, audits, monitoring and other OEC assessments, keep applicable OEC members apprised of relevant information from IRCs, CAPAs, and day to day business issues that impact OEC initiatives.

Requirements:

  • Bachelor's degree is required.
  • One (1) to three (3) years' experience leading employees and projects.
  • Minimum of five (5) years Pharma and/or related experience.
  • Healthcare compliance experience supporting a medical organization preferred

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

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

Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health.

Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

Candidates need to use the following link to apply for the role:
 Job Description - Associate Director, Compliance Business Partner I - Research, Development & Medicine (215257) (taleo.net)

Posted 5/4/2021

DIRECTOR, GLOBAL BUSINESS COUNSELING AND SUPPORT - Merck & Co., Inc.
2 positions
Locations:
1 in Jersey City, NJ and 1 in Lansdale, PA US


Merck & Co., Inc., Kenilworth, New Jersey, USA, has made the decision to spin-off products from its Women's Health, trusted Legacy Brands, and Biosimilars businesses to form a new, independent company. This new company, named "Organon", will become an independent, publicly traded company in 2021 with its global and US headquarters to be based in Jersey City, NJ. We expect that additional Organon sites will be in the general vicinity of current Merck & Co., Inc. locations.

For this exciting new opportunity, we are seeking candidates with an entrepreneurial and learning spirit who are interested in a career of purpose, personal growth and leadership. Working together, we will make a significant impact on the health and lives of people around the world. For more information about Organon, please click here.

 

Job Description
The Director, Global Business Counseling and Support -- (GBC) will support the goal of the Ethics and Compliance Organization to be a "partner in doing the right thing – all the time." The GBC will be responsible for compliance support for the NewCo business, primarily focusing on marketing and sales issues as well as medical affairs, but also supporting other functions as needed. The GBC will pro-actively support client teams in the effective execution of compliant business practices by partnering with them in setting and consulting on policies, providing training and best practices, promoting compliant behaviors, raising issues, and supporting corrective action.

Examples of responsibilities and duties of the position include:

  • End-to-end compliance support to marketing and sales personnel and medical affairs personnel
  • Understanding the business needs, strategic objectives, and operational practices of the client organizations Member of business leadership teams as assigned
  • Provide launch support for marketing and sales teams
  • Oversight and monitoring planning and support
  • Audit support
  • Assigned points for certain Ethics and Compliance-owned policies
  • Cross-functional team support as assigned
  • Having subject matter expertise in the relevant guidance, policies, codes, and regulations, as well as in their applications to the business—including familiarity with at least some of the following: the U.S. anti-kickback statute, State gift laws,  fundamentals of U.S. pharmaceutical product promotion regulation, the PhRMA Code on Interactions with HCPs and similar matters.
  • Applying this expertise in advising and counseling clients on new issues, answering routine questions regarding policy, and assisting in the assessment and implementation of new activities 
  • Assisting in the development and communication of compliance objectives and initiatives to US business stakeholders
  • Maintaining full line-of-sight (from strategic intent through tactical execution) when supporting line management in the development of new or refined guidance to ensure that they are relevant, appropriate, and implementable.  Steps include gathering input, authoring, circulating drafts, gaining necessary approvals, developing communications plans, and integrating the guidance into new or existing training.
  • Utilizing brand knowledge, review materials as part of the Promotion Review Team
  • Providing proactive identification of compliance risks and gaps and leading the development of solutions
  • Developing strong working relationships with key stakeholders in business partner areas, and throughout the compliance organization and legal organization

Education:

  • BA/BS required; advanced degree in business, marketing, law, audit or public policy preferred

Requirements:

  • High degree of ethics and integrity
  • 10+ years business experience (5+ years pharmaceutical industry preferred)
  • Self-motivated and proactive
  • Familiarity with sales or marketing organizations and activities, as well as medical affairs organizations and activities
  • Experience with the development or execution of written policies, guidance, laws, rules or regulations or other significant drafting or writing experience
  • Training or presentation experience in individual or group situations
  • Experience/comfort working with senior managers, and Legal organizations
  • Ability to influence and exercise good judgment
  • Ability to apply knowledge to real world situations
  • Ability to translate and communicate complex concepts clearly
  • Ability to manage multiple projects simultaneously and prioritize activity in alignment with business goals
  • Strong judgment and decision-making skills regarding compliance related topics
  • Strong written and oral communications skills

#NewCo

Our Support Functions deliver services and make recommendations about ways to enhance our workplace and the culture of our organization. Our Support Functions include HR, Finance, Information Technology, Legal, Procurement, Administration, Facilities and Security.

US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here. if you need an accommodation during the application or hiring process.

  For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster
EEOC GINA Supplement
OFCCP EEO Supplement

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status: Regular
Relocation: No relocation
Number of Openings: (2 – 1 in Jersey City, New Jersey and 1 in Lansdale, Pennsylvania)
Requisition ID: R94229

Organon Vision
Organon will improve the lives of people globally by unleashing the promise of trusted brands across women's health and other important therapeutic areas.

We are committed to becoming the world's leading women's health company investing in innovations that support women's well-being

Organon Mission
Invest in innovations to support women's well-being, fueled by our leading contraceptives and fertility business.

Establish a leading position in biosimilars, focusing on oncology and inflammatory diseases, and being a partner in the commercialization of biosimilars worldwide.

  Realize the value of trusted dermatology, pain and cardiovascular portfolio.

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 Apply here
Posted 4/16/2021

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