The Pharmaceutical Compliance Forum

Employment

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EMPLOYMENT OPPORTUNITIES

 

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

To assist in the development, implementation, and continuous improvement of an effective compliance program for all business activities within Commercial. 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 Commercial 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 Commercial 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 Commercial, 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.

Eligibility Requirements:

  • Must be legally authorized to work in the United States without restriction.
  • Must be willing to submit to a background investigation, including verification of your past employment, criminal history, and educational background
  • Must be willing to take a drug test and post-offer physical (if required)
  • Must be 18 years of age or older

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

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

Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA, Inc., Merial Barceloneta, LLC and Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender identity or expression; affectional or sexual orientation; disability; veteran or military status, including protected veteran status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

 Apply here
Posted 1/14/2019

SENIOR MANAGER FOR MEDICAL & SCIENTIFIC COMPLIANCE - Ferring Pharmaceuticals
Location: Parsippany, NJ

Ferring Pharmaceuticals is a globally recognized, research-driven, biopharmaceutical company with more than 65 years of history. Headquartered in Switzerland, Ferring is privately owned with over 5,700 employees in nearly 60 countries. In the United States, Ferring identifies, develops and markets innovative products in the fields of reproductive health (infertility), urology, gastroenterology, endocrinology, women's health (obstetrics/gynecology) and orthopedics. Ferring's US operations employ approximately 800 people.

People Come First At Ferring. The Ferring Philosophy places people at the heart of what we do. This guides our relations with patients, physicians, employees, and other stakeholders. We invite you to share our passion for people and the power of science.

Summary:
The Senior Manager for Medical & Scientific Compliance will be responsible for providing compliance guidance, training, and policies for the conduct of medical and research & development related activities and scientific materials in adherence with applicable regulations, guidelines, industry standards and best practices. Senior Manager will act as the compliance lead across regulatory, medical and scientific initiatives from concept to implementation for Medical, Medical Affairs, MSL, and R&D teams across Ferring and our partners. Role will coordinate and draw on resources from other functions including the broader Compliance Department, including other senior leaders in that function, and through ongoing collaboration with the Medical and R&D Teams.

Responsibilities:

  • Provide sound Compliance advice and guidance on non-promotional materials, scientific exchange, disease state, regulatory, medical/scientific programs and R&D activities to minimize company risk and facilitate adherence in alignment with applicable regulations
  • Develop and execute an engagement and integration plan for US Compliance, and Global Compliance to incorporate requirements and training into all client groups, and vendors, involved with medical and scientific operations
  • Create, implement and monitor an operational and effective Compliance program for policies and procedures in a manner consistent with best practices and applicable laws and guidance
  • Partner with the business support teams, including Legal, Regulatory, and Human Resources, to establish Compliance requirements and guidelines
  • Provide input on Compliance matters to present to key stakeholders and senior leadership
  • Foster a Company culture that focuses on Compliance and ensures on-going commitment to the Ferring Philosophy
  • Develop and maintain SOPs, guidelines, policies and associated internal communications and materials related to non-promotional, Regulatory and medical/scientific programs, including congress activity, clinical symposia, publications, reprints, medical information, advisory boards, ad hoc consulting, IITs, CTs, etc.
  • Liaise with company research entities as well as Global departments to ensure transparency and disclosure reporting and other relevant Compliance policies and processes are being communicated, and in adherence
  • Represent Compliance as the primary point of contact for the evaluation and implementation of SOPs and policies with functional impact and contribute to related standards and guidelines for the review of concepts and activities based on analyses and risks assessments or other areas of potential vulnerability
  • Act as the Compliance lead with all Medical, Scientific, Research and Development activities, including MSLs; from concept to field implementation and serve as the primary Compliance authority on Corporate Contributions, Ed Grants, IITs, Publication, and other elated and scientific team meetings and committees

Requirements:

  • 4+ years of pharmaceutical industry experience, with Compliance, Legal, Medical, or Regulatory experience preferred
  • Bachelor Degree required
  • In depth understanding of PhRMA Code; Federal Food, Drug, Cosmetic Act; Anti-Kickback Statute; OIG Seven Elements; and federal and state transparency and disclosure laws.
  • Strong knowledge of industry compliance activities, regulatory landscape, pharmaceutical compliance training and monitoring programs and best practices
  • Experience in directly implementing and managing risked-based compliance programs and understanding of US pharmaceutical and other regulations.
  • Works well across multiple functions and therapeutic areas
  • Demonstrated ability to develop, launch, deliver, and measure various forms of training.
  • Proficient computer skills: Microsoft Word/Excel/Office/Power Point, Lotus Notes, etc.

 Apply here
Posted 1/8/2019

SENIOR COMPLIANCE OPERATIONS MANAGER - Exelixis
Location: Alameda
Salary Grade: 10
Division: G & A
Job Code: TBD
Department: Healthcare Compliance
FLSA Status: Exempt
Reports To: VP, Compliance
Effective Date: January 2019

SUMMARY:
The Senior Compliance Operations Manager will assist in maintaining and enhancing Exelixis' Compliance Program. More specifically, the individual will be responsible for developing, implementing, communicating and maintaining healthcare compliance policies, practices, systems, and processes, with an emphasis on business integrity, operational excellence, and practicality. The focus will be on managing a policy strategy, including policy development and associated ethics and compliance training, and supporting compliance-related investigations as well as implementation of corrective actions. The Senior Compliance Operations Manager must also have knowledge of, and experience in, conducting compliance auditing & monitoring activities. The essential business partners for this function are corresponding positions in Sales, Marketing, Market Access, Medical Affairs, HR, and Finance.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Promote ethics & compliance under Exelixis' Compliance Program through identification of compliance policy and training needs and development of new and enhanced compliance program activities.
  • Lead and assist in developing and delivering effective and creative training, including written materials, computer-based instruction, and live presentations that leverage adult learning principles and foster greater engagement. This work will require periodic review and standardization of the ethics & compliance training curriculum to ensure consistency and the use of effective teaching methods.
  • Serve as department administrator of the company learning management system and develop innovative compliance tools (e.g., game-based training), aids, and resources to guide ethical decision-making and behavior.
  • Collaborate with key functional area stakeholders to identify risks and issues that may require training and monitoring, and ensure maintenance of policies, processes and investigative protocols on an ongoing basis.
  • Acts as a consultant, reviewer and legal/compliance approver as needed, for business activities that involve Healthcare Compliance risks, and contributes to departmental process and organizational improvements and development, including management of the contract request process for HCP engagements.
  • Support investigations of potential violations of law or company policy and/or ethical standards related to healthcare ethics and compliance matters, provide competent reports on the results of the investigations, and assist with the determination of corrective actions and the implementation of follow up actions.
  • Conduct root cause analysis to understand factors contributing to potential policy violations, develop recommendations, and assist with the design of controls and standards for identified gaps from audit and monitoring activities.
  • Develop and facilitate implementation of corrective action protocols for detected deviations from policy or applicable requirements.
  • Leverage investigative analytics to share actionable insights with key stakeholders. This includes creating trending analysis and the management and utilization of the investigative case matter management system to drive program improvements and organizational understanding of compliance risks.
  • Prepare timely, accurate, and complete reports with corrective action recommendations, including text summaries and graphical presentations of key data, and follow-through with key stakeholders for implementation.
  • Assist in the audit and monitoring of company activities, including field ride-alongs, speaker programs, and advisory boards.
  • Perform other duties as assigned/requested.

SUPERVISORY RESPONSIBILITIES:

  • NONE

EDUCATION/EXPERIENCE/SKILLS:

  Education/Certifications:

  • BS/BA degree in related discipline and 10 years relevant industry experience, or;
  • MS/MA degree in related discipline and 8 years of relevant industry experience; or,
  • Equivalent combination of education and/or experience.
  • CPA, CIA, CFE, CCEP certifications a plus.

  Experience:

  • Prior training experience with demonstrated creativity in training programs required.
  • Prior healthcare compliance related investigations experience with demonstrated independent oversight and significant caseload management required. Must have actual experience in conducting and leading investigations from commencement through to conclusion.
  • Familiarity with the legal principles of FDA advertising and promotion regulations, the False Claims Act, Anti-Kickback Statute, OIG guidance, and the PhRMA Code required.
  • Experience with Polaris software and/or Tableau is a plus.

  Knowledge/Skills/Abilities:

  • Excellent verbal and written communication skills, must be an effective communicator with strong interpersonal skills
  • Strong organizational (detail oriented), project management, and problem-solving skills
  • Ability to handle multiple tasks, prioritize appropriately and adapt quickly to new situations, and offer creative solutions to challenging problems
  • Must be responsible, conscientious, and professional
  • Ability to work under pressure to meet specific deadlines
  • Ability to work independently and also be a team player
  • Must be able to exercise common sense in carrying out tasks
  • Dedication to quality and the highest professional standards
  • Must be a self-starter and quick learner
  • Must have good judgment
  • Strong computer skills (e.g., Microsoft Office Suite (Word, Excel, PowerPoint, etc.), Visio, Internet)
  • Ability to travel

DISCLAIMER:
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

 Apply here
Posted 1/8/2019

SENIOR MANAGER, COMPLIANCE DEPARTMENT - Regeneron

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases.

Summary
The Senior Manager, Compliance Department will assist the Director, Compliance and the Compliance Department in executing aspects of Regeneron's Compliance Program and ensuring full compliance will all applicable laws and regulations. Activities will include management and maintenance of all Compliance training delivered through the Learning Management System (LMS), assisting with written policies and procedures, assisting with development and execution of compliance communications and assistance with project management of all compliance related activities across the organization. Position will interact with departments across Regeneron and assist employees in understanding Regeneron compliance policies and procedures.

Key Responsibilities

  • Manage execution of new online compliance training through the LMS
  • Manage on-going release of new hire on-line compliance training through LMS.
  • Work closely with administrators to manage all on-line compliance training campaigns
  • Analyze Compliance training completion rates and develop reports and recommendations as required
  • Manage the tracking and documentation of Regeneron's Compliance program
  • Assist with policy development and the creation of compliance tools to assist employees across the organization (e.g., PPTs, quick tips, job aids)
  • Assist with developing, enhancing and delivering elements of Regeneron's on-going compliance communication strategy across the organization

Education and Experience

  • BA/BS
  • Experience in LMS management, data analytics and overall healthcare law compliance
  • 7+ years healthcare/pharmaceutical and/or biotech experience.
  • Knowledge of federal fraud and abuse laws, including ACCME guidelines, the Office of Inspector General reports, and the Food, Drug and Cosmetic Act and an understanding of the roles and authority of government agencies and industry cooperative groups including FDA, OIG, and PhRMA.
  • Knowledge of the Physician Payments Sunshine Act and aggregate spend reporting requirements

Required Skills

  • Exceptional communication skills, including presentation capabilities, interpersonal skills and conflict resolution.
  • Excellent negotiation skills requiring exceptional interpersonal communication and oral and written communication skills.
  • Ability to persuade with verbal and written communications involving multiple key client groups.
  • Ability to maintain an independent and objective perspective while developing and maintaining a strong partnership with the client organizations.
  • Exceptional data analytic skills with advanced Excel experience

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.

 Apply here
Posted 12/26/2018

SENIOR MANAGER, COMPLIANCE OPERATIONS - Jazz Pharmaceuticals
Job Location: US-PA-Philadelphia
Job ID: 2018-3959

Overview
Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.

Our therapeutic areas of focus include sleep and hematology/oncology - areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.

We are looking for the best and brightest talent to join our team. If you're looking to be a part of a company with an unwavering commitment to improving patients' lives and being a great place to work, we hope you'll explore our career openings and get to know Jazz Pharmaceuticals.

Position Profile
Brief Description:
The Senior Manager, Compliance Operations is a critical member of the Compliance Operations team. This position is responsible for leading the implementation of various special projects as directed by the Deputy Chief Compliance Officer and Chief Compliance Officer. Such projects include implementing special audit protocols, overseeing development of significant new policies and processes and development of new training programs, some or all of which are driven by changes in the external risk environment or new regulatory requirements. The successful candidate will develop and implement the overall project plans for these projects and assign tasks and monitor progress against those tasks as well as prepare reports summarizing status and progress of such projects.

Essential Functions
The Senior Manager, Compliance Operations serves as a day-to-day project manager for implementation and oversight of special projects which may be driven by changes in external risk environment or new regulatory requirements, including:

  • Ensuring appropriate policies and procedures are implemented;
  • Ensuring that training and education occurs consistent with the special project plan;
  • Assisting the Deputy Chief Compliance Officer and the Chief Compliance Officer in developing and implementing a risk assessment and mitigation program;
  • Assisting the Deputy Chief Compliance Officer in reviewing and enhancing the Company's process to conduct appropriate screening and background checks for employees, contract workers and vendors, where appropriate; and
  • Assisting the Deputy Chief Compliance Officer and the Chief Compliance Officer in the preparation of reports summarizing any of the special projects overseen by the Senior Manager, Compliance Operations.

Required Knowledge, Skills, and Abilities

  • Significant knowledge and understanding of compliance matters, particularly with regard to interaction with healthcare professionals, fraud and abuse, anti-kickback and other compliance matters.
  • Ability to develop and effectively implement a project plan across the company and ensure adherence to budgets, schedules, work plans and performance requirements.
  • Ability to oversee and manage cross-functional issues and projects with team members at all levels of the organization.
  • Ability to resolve a wide range of issues in creative ways.
  • Ability to assign tasks, set deadlines and monitor and summarize progress of completion of those tasks.
  • Ability to change the thinking of or gain acceptance from others in sensitive situations, without damage to the relationship.
  • Ability to prioritize conflicting demands and priorities and manage heavy workload.
  • Ability to manage external consultants and vendors engaged to assist in conducting special projects.
  • Team player with strong interpersonal skills.
  • Strong oral and written communication skills.
  • Ability to work collaboratively and independently as the circumstances require.
  • Self-motivated and detail-oriented.
  • Position may be based in Philadelphia, PA or Palo Alto, CA.
  • Solid organizational skills including attention to detail and multitasking skills.

Required/Preferred Education and Licenses

  • Bachelor's degree required.
  • Minimum of 3 years' industry-related experience in healthcare corporate compliance with demonstrated ability to manage complex projects and teams.
  • Experience working under a corporate integrity agreement preferred.

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

 Apply here
Posted 11/30/2018

DIRECTOR/COMPLIANCE COUNSEL - Heron Therapeutics
Location: San Diego, CA

JOB DESCRIPTION:
This position supports the compliance function and will be responsible for assisting in the development, execution and continuous improvement of the compliance program to ensure compliance with all applicable standards, laws, and regulations, including without limitation the U.S. Anti-Kickback Statutes, the False Claims Act, the Stark Laws, the Sunshine Act (Open Payments), the FCPA and HIPAA. This position will support the Chief Compliance Officer with respect to commercial legal and compliance matters and activities as well as other Legal projects as needed.

ESSENTIAL DUTIES & RESPONSIBILITIES:

  • Monitors activity to help ensure compliance with PhRMA Code with respect to HCP interactions
  • Provide advice and training to employees of the Company on the health care compliance program using a solid understanding of U.S. pharmaceutical laws, including regulatory and compliance issues and laws pertaining to interactions with healthcare providers
  • Provide legal support for wide range of commercial and medical affairs activities related to product launch and ongoing promotion of pharmaceutical products
  • Provide legal guidance to Promotional Review Committee
  • Provide legal guidance to Medical Review Committee
  • Provide legal guidance to Grants Committee
  • Stay current on applicable law, regulation, and practice and communicating senior management apprised of current developments

REQUIREMENTS:

  • Minimum of 3-5 years relevant commercial compliance experience, including prior in-house experience with a biotech/pharmaceutical company
  • BA/BS degree and JD required
  • A solid understanding of U.S. pharmaceutical laws, including regulatory and compliance issues
  • A solid understanding of laws pertaining to interactions with healthcare providers (Anti-Kickback, False Claims etc.)
  • Ability to handle highly confidential and sensitive materials and information with complete discretion
  • Ability to provide commercial contracting support also strongly preferred
  • Ability to work with external counsel, vendors and business partners
  • Ability to work within a very small legal/compliance department, and establish and maintain relationships across multiple corporate functions
  • Adaptable and flexible, able to prioritize duties and manage multiple matters from start to finish with minimal supervision
  • Exceptional attention to detail and excellent organizational skills and the ability to work on a variety of tasks and projects simultaneously with minimal supervision.
  • Ability to work cooperatively and collaboratively with all functions and levels of the Company
  • Proven ability to communicate effectively in a variety of difficult and sensitive situations
  • Ability to thrive in a dynamic and past-paced environment

EOE
The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.

Send resume to: jobs@herontx.com.
Posted 11/29/2018

MANAGER, COMPLIANCE - Horizon Pharma
Lake Forest, IL

Working at Horizon Pharma is more than a job - it's personal. We define success by a different set of numbers: the number of lives touched, the number of lives changed, the number of lives saved. We're a team of agile, out-of-the-box thinkers who are inspired to do more because we know we're a part of something bigger. We strive to build meaningful careers at a company whose values we share because when we live up to our potential, we help patients live up to theirs.

Seeking an experienced compliance professional responsible for supporting Horizon's compliance department.The Manager, Compliance possess working knowledge of the current healthcare compliance environment and pharmaceutical industry.This role will be responsible for global transparency reporting obligations for the organization as well as compliance data analytics. In addition, the role will assist with compliance program operations and provide policy guidance to the business.

Job Description

  • Manage the company's aggregate spend system and ensure applicable data are being captured and accurately reported for international, federal and state government transparency reporting purposes.
  • Conduct aggregate spend system training for employees and vendors.
  • Perform data analytics, data correction, and associated remedial action.
  • Leverage aggregate spend data and additional company data sources to create compliance data monitoring dashboards and executive reports.
  • Assist in development of policies and work instructions to reflect the processes associated with aggregate spend reporting and data analytics.
  • Conduct field ride alongs and speaker program observations to monitor key compliance risk areas. Draft observation reports and identify corrective actions
  • Provide advice and support to Sales, Marketing, Commercial Operations and other key business stakeholders.
  • Assist in developing compliance training, compliance policy development, investigations, and auditing, as needed.
  • Other duties as assigned.

Qualifications and Skills Required:

  • Experience in the healthcare industry and experience with transparency reporting
  • Strong MS Excel skills required
  • Organized, analytical, and attention to detail required
  • Ownership driven with a sense of urgency
  • Ability to communicate and work effectively within a team, cross-functionally, and with leadership
  • Must also be comfortable as a self- starter, creative thinker, and independent worker
  • Ability to multi-task and be flexible in a changing and fast paced environment
  • Comfortable speaking in public.

Horizon Pharma plc does not discriminate on the basis of race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. Any individual, who, because of a disability, needs accommodation or assistance in completing this application or at any time during the application process, should contact the Human Resources Department.

 Apply here
Posted 11/28/2018

MANAGER - GOVERNMENT ACCOUNTABILITY - Novo Nordisk


About the Department
At Novo Nordisk, we're committed to building the best Compliance team in the pharmaceutical industry. Operating at the highest ethical standards and ensuring adherence to corporate and legal regulations, the Compliance team is constantly called upon to design and implement creative solutions to complex issues. From training on new procedures, to auditing against local and corporate policies, to reporting compliance-related issues, Compliance keeps us accountable every step of the way as we develop life-changing therapies and bring them to market. At Novo Nordisk, you will be part of a company respected equally for its financial results and its business ethics. Are you ready to make a difference?

The Position
This position is responsible for supporting the daily operational activities related to the Ethics & Compliance (E&C) Department's Government Accountability Program ("Program"). This position will be directly engaged with reviewing compliance with Federal PDMA obligations, local/state sample obligations, Drug/Sharp takeback compliance, and associated reporting. The position will also support other Programs as required. Additionally, this position will serve as the point of contact for E&C Department systems to interface with other Line of Business ("LoB") systems, ensuring compliance objectives are met and coordination between them to ensure the Program's effectiveness.

Relationships
Reports to the Director - Government Accountability. Regularly interacts with all other functional E&C areas and LoB (e.g. Legal, Information Technology, Commercial Effectiveness, Clinical Operations, and Marketing Effectiveness). The position will also interact with external customers including Health Care Professionals (HCP), third party/external vendors, and external consultants. This position may interact with government officials. This position may manage employees in Novo Nordisk Inc (NNI's) Global Servicing Center in Bangalore.

Essential Functions

  • Supports the Director - Government Accountability in facilitating and raising awareness of the Program while fostering accountability for E&C program throughout the organization
  • Maintains understanding of laws and regulations, enforcement actions and evolving practices relevant to pharmaceutical ethics & compliance and proposes updates to the Program, as appropriate
  • Manages the review and timely reporting of all government requirements while understanding NNI, local and global impacts
  • Responsible for creating and executing an Organizational Change Management (OCM) Plan for the Government Accountability programs
  • Informs management of ethics & compliance issues in a timely manner while encouraging the flow of information between colleagues and LoB
  • Actively works to identify, analyze, and mitigate potential business ethics and other risks to the organization
  • Supports the Director with Business Assurance (BA) and Business Ethics & Compliance Office (BECO) collaborations regarding government requirements and integration of systems/data
  • Supports NN affiliates (e.g., NNCI) with implementing and maintaining a government accountability program
  • Recommends enhancements to systems, processes and technologies for government reporting
  • Manages creation and continued maintenance of government accountability protocols and assumption documents to support accurate filings and internal documentation
  • Conducts training to employees and third party vendors to timely communicate new government requirements or updated NN interpretations
  • Supports the government accountability budget (e.g. forecasting expenditures, reporting variances, and ensuring responsible spending) as requested
  • Maintains understanding of applicable laws and regulations, enforcement actions and evolving practices/trends relevant to pharmaceutical compliance
  • Responsible for development of annual plan to strengthen NNI's confidence when attesting to government reports (e.g., sample transparency, compliance program attestations). Support remediation and mitigation activities as they relate to Government Accountability Ensure that controls are in place for reporting completeness, consistency, accuracy, and integrity to strengthen and support the sub-certification/attestation process
  • Responsible for ensuring that E&C senior management is informed of compliance issues in a timely manner
  • Additional responsibilities with Government Accountability or departmental operational impact as assigned

Physical Requirements
0-10% overnight travel required.

Qualifications

  • A Bachelor's degree from an accredited institution required
  • A minimum of 8 years combined pharmaceutical, legal, regulatory, and compliance experience required OR a minimum of 6 years' experience required if accompanied by an advanced degree or certificate (e.g. MBA, JD, PMP)
  • Demonstrates functional knowledge and understanding of the Anti-kickback Statute, the False Claims Act, Food and Drug Administration (FDA) rules and regulations regarding the promotion of pharmaceuticals, government corporate integrity agreements, PhRMA and federal and state aggregate spend reporting requirements
  • Knowledge and experience with pharmaceutical aggregate spend solutions and data associated with promotional and clinical data, preferred
  • Experience working under a government agreement (e.g. CIA, DPA, Consent Decree) is required
  • Demonstrates strong interpersonal skills and ability to influence at all levels of the organization
  • Excellent communication and organization skills
  • Excellent project management skills to oversee and drive project execution
  • Ability to manage multiple projects concurrently and collaborate across several functional areas
  • The ability to think objectively and use sound reasoning principles
  • Ability to manage multiple projects to completion meeting internal and external deliverables with high degree of accuracy
  • Excellent communication skills (written and verbal), strong report writing skills and organization skills are required
  • Uncompromising ethics and high standard of personal integrity
  • Ability to work proactively and independently with minimal supervision
  • Proficiency in Microsoft Office Suite
  • Supervisory experience preferred

Novo Nordisk is an Equal Opportunity Employer /F/Veteran/Disability/Sexual Orientation/Gender Identity.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

 Apply here
Posted 11/26/2018

ETHICS AND COMPLIANCE MANAGER NA - Ipsen

Company Profile
Ipsen is a dynamic and growing global specialty-driven biopharmaceutical company, focused on innovation and specialty care. At Ipsen, we've created a workplace that recognizes and promotes an entrepreneurial spirit in our employees, and are building a strong legacy of helping patients with difficult-to-treat diseases across oncology, neurosciences and rare diseases. We know we can only be better and smarter if we work diligently together as ONE Ipsen, across all functions and geographies. We strive to break down silos and empower teams to deliver effective therapeutic solutions through highly differentiated medicines for patients with unmet needs.

We take pride in our culture, which is rooted in collaboration, to deliver results for our core customer - the patient. This level of involvement by cross-functional teams promotes a strong sense of unity, and pulls together all colleagues locally and across our key geographies, which span 115 countries across North America, Europe and Asia. As a growing organization, Ipsen North America is comprised of our Cambridge, MA, Basking Ridge, NJ and Toronto, Canada locations, with employees supporting functions including Commercial Operations, R&D, Business Development and Technical Operations.

Our employees are the driving force behind our mission at Ipsen, and to sustain their passion and focus every day, we offer a wealth of fulfilling challenges and growth opportunities through unique leadership and training programs. At Ipsen, you will work alongside industry leaders and contribute within a fast-moving and truly game-changing global organization, recognized for its talent and patient solutions. At Ipsen, we're making hope a reality for the patients we serve.

Position Summary
This position is responsible for managing compliance processes, including the preparation, communication, implementation and monitoring of adherence to, policies and standards to promote compliance with legal and regulatory requirements. Provides compliance advice and support to the company, its subsidiaries and affiliates. Performs a variety of investigations, and follows-up on others, through resolution. Leads and/or participates in other compliance projects, as needed. The individual should enjoy working collaboratively with other functional areas and also be comfortable with a significant degree of autonomy. This is a great opportunity to be an integral part of a dynamic Ethics and Compliance group.

Essential Functions
  Responsibilities
  Responsibilities will include, but are not limited to, the following:

  • Oversee implementation of compliance recommendations, including those that result from due diligence findings
  • Lead risk assessments, work with internal audit to review program compliance, and utilize analytics to monitor it, identify areas of risk and prioritize risk mitigation
  • Proficiency on federal, state and global legal/regulatory requirements and timely responds to field inquiries
  • Work closely with the Transparency team to advise on compliance implications under the Sunshine Act
  • Lead on implementation of compliance recommendations and documentation/records for commercial programs and initiatives
  • Review and prepare documentation related to Anti-kickback and Sunshine controls - contracts and forms review
  • Maintain library of anti-kickback and Sunshine compliance forms and provide them to operations for consistency
  • Prepare dispute resolution procedures and advise on process
  • Publish periodic FAQs and commercial guidance, as appropriate
  • Lead training initiatives, and develop the respective materials within areas of responsibility
  • Create guidelines and tools, and advise different cross-functional teams to ensure compliance
  • Assist with other compliance work as needed (may involve international matters)
  • Maintain a current working knowledge of various laws, regulations, and industry guidance that affect the corporate-wide compliance program, including federal and state government price reporting laws, fraud and abuse and anti-kickback statutes, OIG guidelines, industry codes in relevant markets including PhRMA, US state marketing compliance laws, FCPA, UK Bribery Act, and other anti-bribery laws.

Qualifications
  Education and experience

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

Core Competencies (Specific knowledge, skills and abilities that enable an individual to effectively perform the job)

  • Strong management skills and ability to attract, retain, motivate and develop junior team members for high performance
  • Excellent verbal and written communication skills and ability to resolve disputes effectively
  • Strong presentation and public speaking skills
  • Ability to manage projects, risks, cost, time and project teams
  • Work effectively with team members to achieve company goals in effective ways
  • Strong planning and organizational skills and techniques
  • Communicate effectively with management
  • Good negotiating skills
  • Build strong relationships, understand organizational complexities and manage conflict
  • Broad professional and managerial skills with an understanding of industry practices and company policies and procedures

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

Ipsen Biopharmaceuticals, Inc. is an equal opportunity employer. We recruit, employ, train, compensate, and promote without regard to race, religion, creed, national origin, age, gender, sexual orientation, sexual identity, marital status, military or veteran status, disability, genetic information, or any other category protected by applicable federal, state or local law.

Ipsen Biopharmaceuticals, Inc. conducts background screening, reference checks, and drug testing as part of its pre-employment screening process. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned.

All Employees are expected to adhere to all company policies and act as a role model for company values.

Note: This description is not intended to be construed as an exhaustive list of duties, responsibilities or requirement for the position. This position may change at any time and the employee may be requested to perform different or additional duties as assigned.

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Posted 11/19/2018

CORPORATE COMPLIANCE DIRECTOR - Indivior
Location: Slough


Indivior is a global specialty pharmaceutical company with a 20-year legacy of leadership in patient advocacy, health policy and evidence-based best practice models that have revolutionized modern addiction treatment. The name is the blend of the words individual and endeavor, and the tagline "Focus on you" makes the company's commitment clear. It represents and empathizes with the often-difficult journey each individual patient takes to overcome the challenges of addiction - a chronic relapsing disease.

Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. The Indivior logo radiates its patient-focused, holistic focus on expanding access to quality treatment for addiction worldwide. The company has a strong pipeline of products and candidates designed to both expand on its heritage in global opioid dependence and address other chronic diseases of addiction - including opiate overdose, alcohol use disorders and cocaine intoxication - as well as related mental health disorders such as schizophrenia.

POSITION SUMMARY:
The Director, EMEA Corporate Compliance will be responsible for managing, enhancing and implementing Indivior's EMEA corporate compliance program and establishing clear policies and offering pragmatic guidance to the EMEA Area Business to help ensure compliance with applicable EU and local country laws, regulations and industry codes.

ESSENTIAL FUNCTIONS:

  • Leading the development, maintenance and evolution of policies, procedures and controls to help ensure compliance with Anti-Bribery and Anti-Corruption regulations and practices.
  • Developing, maintaining and disseminating EMEA Area Business corporate compliance policies, procedures and guidance materials, consistent with the Company's corporate compliance policies and guidelines, the Code of Business Conduct and underlying policies, other standard operating procedures, and pharmaceutical industry guidelines and best practices. This role will ensure alignment to local country requirements where appropriate ("Company Policies").
  • Participating or overseeing third-party due diligence assessments and monitoring processes for commercial distributors and other business partners.
  • Development and implementation of educational training programs on such EMEA and local country policies in appropriate language, along with monitoring completion of educational training programs.
  • Monitoring the EMEA Area Business functional leaders' compliance with Company Policies.
  • Facilitating and coordinating the development, maintenance and dissemination of other educational training content developed by members of the Corporate Compliance & Legal Departments.
  • Monitoring and assessing business practices and activities for compliance with Company Policies and assisting with the development and implementation of process and control enhancements.
  • Staying abreast of changes in pharmaceutical industry compliance standards for purpose of assessing and adopting changes to existing EMEA Area Business corporate compliance policies and SOPs.
  • Overseeing and providing Compliance certification of the Company's analysis and submission of payment reporting obligations and adherence to ABPI and EFPIA transparency requirements across EMEA business.
  • Chairing, participating and managing the EMEA Area Business's Compliance Committee and any local compliance committees.
  • Reporting of compliance matters to the Compliance Committee and Senior Management.
  • Carrying out other tasks and activities related to the development, execution and maintenance of the EMEA Area Business's compliance program.
  • Ensuring compliance across a wide geographic region with country variances
  • Providing pragmatic approach to deliver solutions in a commercial environment within a compliance framework
  • Implementing and driving compliance from regional to country level understanding within global framework of Indivior Code of Conduct.

MINIMUM QUALIFICATIONS:

  • BA (Hons) or BSc(Hons) 2.1 or above, educated
  • Law Degree not required, but is preferred
  • Minimum 7-10 years of experience in either the pharmaceutical or medical device industry including a minimum of 5 years in a senior or regional healthcare compliance role, with some personnel management responsibility
  • Detailed understanding of government regulations governing healthcare compliance programs.
  • Specific programmatic experience developing or executing Antibribery and Anti-Corruption compliance program
  • Ability to work closely and collaboratively with other business functions and Departments.
  • Strong project management skill set and a consistent driver of the change management process.
  • Experience in leading, planning, and conducting reporting on monitoring activities.

COMPETENCIES/CONDUCT:
In addition to the minimum qualifications, the employee will demonstrate:

  • Flexibility in thinking and pragmatic problem-solving skills
  • Excellent interpersonal, communication and presentation skills.
  • Strong influencing skills and ability to exercise sound business judgment
  • Ability to work independently and manage a diverse and demanding workload.
  • Willingness to work in a dynamic, fast-paced environment.
  • High standards of professional integrity and independence.
  • Able to effectively influence senior management and functions to drive change and improvement
  • Displays a high sense of urgency
  • Flexible to travel if required
  • Tenacity and robustness
  • The business language in Indivior is English, fluency in local languages advantageous

GUIDING PRINCIPLES:
Indivior's guiding principles are the foundation for each employee's success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance.

The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time.

EQUAL EMPLOYMENT OPPORTUNITY
EOE/Minorities/Females/Vet/Disabled

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Posted 10/30/2018

DIRECTOR, COMPLIANCE OPERATIONS - Insmed
Department Name: Global Compliance
Manager Name & Title: Tiffany Cumming-Damiani, Executive Director, Corporate Compliance, Policies and Training
Effective Date: May 31, 2018 (updated Oct 5 2018)


Supervision of Others: (internal/external):

  • This position reports directly to the Executive Director, Corporate Compliance, Policies and Training
  • This is a non-supervisory position at this time and may change as the Global Compliance function grows.

General Purpose of Role:
With the Executive Director, Corporate Compliance, Policies and Training, implement and manage compliance operations functionality for Insmed's Global Compliance group and to provide guidance to Insmed's US and global (EU, Japan) operations. This role will be based at our Bridgewater, New Jersey headquarters location.

Responsibilities: Following is a list of essential duties, functions and responsibilities.

  • Implement and manage day-to-to operations for the hiring of healthcare professionals including process development, software implementation, fair market value and lifecycle management
  • Implement and manage US transparency program with scalability to global, including oversight of outsourced reporting vendor
  • Support policy and process development, updates and translations as assigned along with any training or communications
  • Partner with the US, EU and Japan businesses to provide guidance and support as needed
  • Provide guidance and support to US business
  • Identify continuous improvement activities to continue to enhance and grow the compliance function
  • Lead remediation efforts as needed, resulting from compliance monitoring and auditing

Position Requirements:

Knowledge & Experience

  • Knowledge of US and global compliance regulations, laws and standards
  • Experience working globally (EU, Japan)
  • Experience in engaging healthcare professionals processes
  • In depth knowledge of US transparency laws and reporting processes
  • Experience in developing and implement compliance processes and software (e.g. hiring healthcare professionals' software, third party due diligence software)
  • Experience in continuous improvement for compliance programs

Qualifications

  • Bachelor's degree required; advance degree preferred.
  • Compliance certification is a plus
  • At least 10 years' experience in corporate compliance for a pharmaceutical or biotech company

Skills

  • Must have excellent communication skills (verbal and written).
  • Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
  • Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).

Other (if applicable):

  • Domestic and international travel may be required occasionally (5-10%)
  • Must successfully exhibit Insmed's five (5) core corporate competencies of: Excellence, Accountability, Driven, Collaborative and Solutions; along with any other position specific competencies.
  • Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.

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Posted 10/30/2018

ASSOCIATE DIRECTOR - ETHICS & COMPLIANCE OPERATIONS - Novo Nordisk

About the Department
At Novo Nordisk, we're committed to building the best Compliance team in the pharmaceutical industry. Operating at the highest ethical standards and ensuring adherence to corporate and legal regulations, the Compliance team is constantly called upon to design and implement creative solutions to complex issues. From training on new procedures, to auditing against local and corporate policies, to reporting compliance-related issues, Compliance keeps us accountable every step of the way as we develop life-changing therapies and bring them to market. At Novo Nordisk, you will be part of a company respected equally for its financial results and its business ethics. Are you ready to make a difference?

The Position
This position leads and manages the development and implementation of the U.S. healthcare ethics and compliance program function for compliance and department operations including department strategy, business planning, affiliate support and other key department processes. This position performs special projects, assists in development and execution of Ethics & Compliance (E&C) plan across functions/organizational lines, and provides additional leadership in Ethics and Compliance Department as requested.

Relationships
Reports to the Senior Director, Ethics & Compliance Operations, Monitoring & Auditing (M&A), and Government Accountability. Manages two or more Novo Nordisk Inc (NNI) E&C professionals and dedicated compliance professionals in Global Service Center (GSC), Bangalore. Internal relationships include in-house legal counsel, global compliance colleagues, senior leaders throughout lines of business. Supports North American affiliates (e.g. NNCI, NNRCSI). External relationships include vendors and consultants as well as developing and maintaining relationships with the broader E&C network within the industry.

Essential Functions

  • Supports the Senior Director in facilitating and raising awareness of the E&C program while fostering accountability for compliance throughout the organization
  • Fosters a continuous improvement mindset and proposes enhancements to the E&C program, informed by industry trends and best practices
  • Champions a proactive approach to E&C that is focused on partnership, prevent and risk mitigation
  • Participates in industry associations and engagements to raise the profile of the E&C Program
  • Operationalizes and implements holistic processes for business planning that ensures coordination of 1/3/5 year E&C and NNI milestones
  • Provides strategic E&C and operational support and guidance for North America affiliates related to ethics and compliance broadly, including relevant reporting requirements
  • Runs projects of varying size both within E&C and across NNI
  • Development and implementation of efficient systems, processes, and technologies to meet operational requirements (e.g., Exclusions processes, contracts, TPRs,)
  • Operationalizes key initiatives with the global Business E&C Office by supporting the strategic annual operations plan while understanding global and local impact
  • Creates annual plan for and manages GSC Bangalore office
  • Responsible for proactively identifying additional off shore/near shore work opportunities or enhancements
  • Provides direction for department operations functions, including planning key meetings, department wide development opportunities, and other functions
  • Works collaboratively with the Strategy & Education groups to support the development, implementation and maintenance of platforms and tools for employees and third parties to access company standards related to E&C
  • Ensures that the Circle of Excellence (COE) works cross-functionally to collaborate with business leaders to ensure that Standard Operating procedures (SOPs) are developed and implemented, as appropriate, to help enable the implementation of NNI's E&C policies
  • Continuously supports the enhancement of E&C communications, education and training
  • Creates content for key E&C Department meetings (e.g. off-sites, lunch & learns)
  • Manages E&C department related HR processes (e.g. JD updates, career frameworks)
  • Responsible for E&C department educational activities
  • Management of department budget and contracting processes, including forecasting expenditures and establishing practices that promote and support responsible spending, tracking and rationale regarding allocation
  • Manages the annual certification processes
  • Administrative support for the entire E&C Department
  • Provides additional support to the Government Accountability and E&C M&A functions as requested

Physical Requirements

  • 10-15% overnight travel required.

Development of People

  • Supervisory

Qualifications

  • A Bachelor's degree from an accredited institution is required. Additional education/certification within the compliance and health-care related fields is preferred
  • A minimum of 10+ years combined pharmaceutical, legal, regulatory, and compliance experience required OR 8+ years' experience if accompanied by an advanced degree or certification (e.g. MBA, JD, PMP)
  • Uncompromising ethics and high standard of personal integrity
  • Experience working under a government agreement (e.g. CIA, DPA, Consent Decree) is required
  • Demonstrates strong interpersonal skills and exceptional ability to influence at all levels of the organization
  • Demonstrated knowledge and understanding of the Anti-Kickback Statute and False Claims Act, FDA rules and regulations regarding the promotion of pharmaceuticals, corporate integrity agreements and other prosecution agreements with other pharmaceutical companies, PhRMA code and other relevant federal and state aggregate spend reporting requirements, and the current activities and developments involving pharmaceutical sales and marketing required
  • Demonstrated knowledge and clear understanding of the required elements of effective ethics and compliance programs as outlined in the Health & Human Services (HHS) Office of Inspector General (OIG) Compliance Program Guidance and the US Federal Sentencing Guidelines
  • Demonstrated ability to build and maintain effective strategic relationships and networks with internal and external stakeholders
  • Demonstrated ability to manage and lead change in a large, matrix organization
  • Effective time management skills
  • Communicates effectively with different audiences and in different contexts
  • Ability to drive multiple projects to completion meeting internal and external deliverables with high degree of accuracy
  • Prior experience managing professionals required
  • The ability to think objectively and use sound reasoning principles
  • Demonstrated strong interpersonal skills and ability to influence at all levels of the organization
  • Proficiency in MS Office Suite

Novo Nordisk is an Equal Opportunity Employer /F/Veteran/Disability/Sexual Orientation/Gender Identity.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
 Apply here
Posted 10/27/2018

ASSOCIATE DIRECTOR - ETHICS & COMPLIANCE RISK & MITIGATION - Novo Nordisk

About the Department
At Novo Nordisk, we're committed to building the best Compliance team in the pharmaceutical industry. Operating at the highest ethical standards and ensuring adherence to corporate and legal regulations, the Compliance team is constantly called upon to design and implement creative solutions to complex issues. From training on new procedures, to auditing against local and corporate policies, to reporting compliance-related issues, Compliance keeps us accountable every step of the way as we develop life-changing therapies and bring them to market. At Novo Nordisk, you will be part of a company respected equally for its financial results and its business ethics. Are you ready to make a difference?

The Position
This position supports the Director, E&C Strategy, Risk & Education with regard to the planning, design, and enablement of the NNI Ethics & Health Care Compliance Program strategy, as well as all aspects of the ethics and compliance risk management process. This position executes and supports the implementation of the Novo Nordisk Inc. ("NNI") Risk Assessment and Mitigation Program and is responsible for the management, tracking, and reporting of Ethics & Compliance ("E&C") risk assessments and the associated mitigation/remediation activities. This position also performs special projects within the department as requested.

Relationships
Directly supports the Director - Planning, Designing, and Enablement with regard to the execution of the Ethics & Compliance program. Closely collaborates with NNI's in-house legal counsel, other leaders across lines of business, and is a member of cross-functional teams throughout NNI. External relationships include vendors, outside counsel, industry peers, and government agencies.

Essential Functions

  • Raises awareness of the program and fosters accountability for ethics and compliance throughout the organization
  • Fosters a continuous improvement mindset and proposes enhancements to the Program informed by industry trends and best practices
  • Champions a proactive approach to ethics and compliance that is focused on partnership, prevention and risk mitigation
  • Participates in industry associations and engagements to raise the profile of the E&C Program and the company
  • Supports the Director in working with the CECO to ensure implementation of any external government reporting requirements
  • Supports Director in designing collaboratively NNI's ethics and compliance risk assessment process, framework, and methodology
  • Supports Director in leading collaboratively the implementation of ethics and compliance risk assessments
  • Supports Director in developing and driving a consistent definition of "ethics and compliance risk" across the organization
  • Supports Director in working collaboratively with ethics and compliance risk assessment cross-functional team members to identify, prioritize, and assign accountability for managing ethics and compliance risks throughout NNI's operations
  • Supports Director in working collaboratively with NNI's cross-functional ethics and compliance risk management stakeholders to develop risk mitigation plans and strives to hold risk owners accountable for action plan delivery and implementation
  • Supports Director in identifying and reporting high-level trends and insights to E&C peers and the broader organization; develops reports for executive leadership and multiple oversight committees
  • Supports Director in working closely with data gathering functions in other departments and identifies opportunities to leverage existing data sets for improved ethics and compliance trending and analytics
  • Supports Director in overseeing the implementation of mitigation plans and processes to facilitate appropriate triage, follow-up and close-out of identified health care compliance issues across all NNI products, therapeutic areas and functional areas
  • Supports Director in championing the implementation of new technologies to aid the risk assessment and mitigation process
  • Supports Director in actively overseeing stakeholder engagement, builds and maintains strategic relationships throughout NNI, and navigates the organization to facilitate risk assessment and mitigation efforts
  • Supports Director in working collaboratively with internal audit and monitoring functions to incorporate risk assessment results and emerging trends into auditing and monitoring plans

Physical Requirements

  • 0-10% overnight travel required.

Qualifications

  • A Bachelor's degree from an accredited institution is required. Additional education/certification within the compliance and health-care related fields is preferred
  • A minimum of 10 years combined pharmaceutical, legal, regulatory, and compliance experience required OR 8 years' experience if accompanied by an advanced degree or certification (e.g. MBA, JD, PMP)
  • Prior experience working under a government agreement (e.g. CIA, DPA, Consent Decree) required
  • Strong health care compliance background and clear understanding of elements of an effective ethics and compliance program
  • Maintains understanding of laws and regulations, enforcement actions and evolving best practices relevant to pharmaceutical ethics & compliance and proposes updates to Ethics & Compliance program, develops plan and deliverables to inform relevant internal functions
  • Uncompromising ethics and high standard of personal integrity
  • Excellent written and verbal communication and interpersonal skills required. Ability to interact with all levels of the business
  • Handles confidential information with discretion and uses information to inform strategic thinking and approach to compliance matters
  • Demonstrated ability in leadership/collaboration skills with the ability to develop and communicate a vision and engage people in that vision
  • Demonstrated ability to display expert level critical thinking in applying principles, theories and concepts on a wide range of problems
  • Demonstrated ability in creating strategic direction, plans and proven ability to drive and sustain business improvement and results
  • Communicates effectively with different audiences and in different contexts
  • Proficiency in Microsoft Office Suite

Novo Nordisk is an Equal Opportunity Employer /F/Veteran/Disability/Sexual Orientation/Gender Identity.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
 Apply here
Posted 10/27/2018

MANAGER - ETHICS AND COMPLIANCE MONITORING & AUDITING - Novo Nordisk

About the Department
At Novo Nordisk, we're committed to building the best Compliance team in the pharmaceutical industry. Operating at the highest ethical standards and ensuring adherence to corporate and legal regulations, the Compliance team is constantly called upon to design and implement creative solutions to complex issues. From training on new procedures, to auditing against local and corporate policies, to reporting compliance-related issues, Compliance keeps us accountable every step of the way as we develop life-changing therapies and bring them to market. At Novo Nordisk, you will be part of a company respected equally for its financial results and its business ethics. Are you ready to make a difference?

The Position
This position is responsible for executing against the Novo Nordisk Inc (NNI) Ethics and Compliance (E&C) Department's annual Monitoring & Auditing (M&A) strategic plan. This role will conduct monitoring activities and audits of various company records, manage the development and implementation of remediation processes, assist with investigations related to audit findings and allegations of non-compliance with Company policy, preparing regular reports and presentations in a form that is consistent with internal and external reporting requirements.

Relationships
Reports to the Associate Director - Monitoring & Auditing or designee. Closely collaborates with NNI's in-house legal counsel, leaders across lines of business, and is a member of cross-functional teams throughout NNI. The position will also interact with external customers including Health Care Professionals (HCP), third party/external vendors, and external consultants. This position may interact with government officials. This position may manage employees in NNI's Global Servicing Center in Bangalore.

Essential Functions

  • Support the Associate Director, Monitoring & Auditing in facilitating and raising awareness of the Ethics & Compliance program while fostering accountability for compliance throughout the organization
  • Maintain understanding of laws and regulations, enforcement actions and evolving practices relevant to pharmaceutical compliance and proposes updates to ethics & compliance program, as appropriate
  • Identify, analyze, and mitigate potential business ethics risks to the organization
  • Support the development and manage the implementation of a robust health care compliance monitoring and auditing plan
  • Develop and maintain knowledge and understanding of: (1) Novo Nordisk Diabetes, Obesity, and BioPharm disease state and products, (2) industry regulations and guidelines (e.g., laws and regulations regarding pharmaceutical advertising and promotion, Federal Anti-Kickback Statute, False Claims Act, PDMA), Novo Nordisk policies and procedures, and government reporting requirements as needed
  • Develop and manage protocols, guidelines and associated internal communication and documentation related to E&C testing and monitoring
  • Develop and manage the remediation and mitigation process on for the M&A team
  • Manage the full cycle of assigned review processes (e.g. management of third party vendors)
  • Review records and systems relating to interactions with healthcare professionals and institutions, conduct field monitoring visits and monitor various company-sponsored activities to ensure adherence with relevant laws, regulations, industry codes, and company policies
  • Support E&C audits for North America and NN affiliates (e.g. NNRCSI, Business Ethics & Compliance Office (BECO), LatAm) in support of annual auditing plan and/or ad hoc audits as requested
  • Review and follow-up on suspected areas of non-compliance and collaborate with NNI Ethics & Compliance teams as needed
  • Collaborate with compliance colleagues and line of business to help develop and implement remediation and mitigation plans
  • Prepare quarterly and ad hoc reports and presentations summarizing monitoring and auditing monitoring

Physical Requirements

  • 20-30% overnight travel required.

Qualifications

  • A Bachelor's degree from an accredited institution required
  • A minimum of 8 years combined pharmaceutical, legal, regulatory, and compliance experience required OR a minimum of 6 years' experience required if accompanied by an advanced degree or certificate (e.g. MBA, JD, PMP)
  • Demonstrated knowledge and understanding of the Anti-Kickback Statute and False Claims Act, Food and Drug Administration (FDA) rules and regulations regarding the promotion of pharmaceuticals, corporate integrity agreements, PhRMA code, and other relevant reporting requirements
  • Compliance auditing and/or monitoring experience in the Pharmaceutical or life sciences industry is required
  • Experience working under a government agreement (e.g. CIA, DPA, Consent Decree) is required
  • Demonstrates strong interpersonal skills and ability to influence at all levels of the organization
  • Excellent communication and organization skills
  • Excellent project management skills to oversee and drive project execution
  • Ability to manage multiple projects concurrently and collaborate across several functional areas
  • The ability to think objectively and use sound reasoning principles
  • Ability to manage multiple projects to completion meeting internal and external deliverables with high degree of accuracy
  • Excellent communication skills (written and verbal), strong report writing skills and organization skills are required
  • Uncompromising ethics and high standard of personal integrity
  • Ability to work proactively and independently with minimal supervision
  • Proficiency in Microsoft Office Suite
  • Supervisory experience preferred

Novo Nordisk is an Equal Opportunity Employer /F/Veteran/Disability/Sexual Orientation/Gender Identity.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
 Apply here
Posted 10/27/2018

MANAGER, OFFICE OF BUSINESS INTEGRITY AND ETHICS - Vertex Pharmaceuticals
Office of Business Integrity and Ethics
Boston, MA
Full-Time


Job Description
As part of the transformation and growth of its world-class compliance program, Vertex Pharmaceuticals is seeking an experienced candidate to join its Office of Business Integrity and Ethics (OBIE) team. OBIE serves as the primary contact for Vertex employees, shareholders, business partners, patients and the general public on issues relating to the implementation of and compliance with Vertex's Code of Conduct globally. The Office is accountable for supervising, coordinating and continuously improving Vertex's Compliance Program ("Program"). This includes defining compliance standards via policies and procedures, compliance training and communications, auditing and monitoring, facilitating internal reporting, compliance-related investigations, and keeping the Executive Committee and the Audit Committee of the Board of Directors informed on compliance matters.

Reporting to the Head of Global Operations, the Manager/Senior Manager will be responsible for supporting all aspects of the Global Operations Team, including policy creation and drafting, training and communications, transactional and live monitoring, auditing, and enhancing its Global Anti-Bribery/Anti-Corruption Program. The Manager/Senior Manager must have knowledge of the Anti-Kickback Statute and the Foreign Corrupt Practices Act and should have experience working with or for biotechnology/pharmaceutical companies on these issues. The Manager/Senior Manager will work collaboratively and strategically with colleagues in the Office of Business Integrity & Ethics, Legal and the business to drive a culture of ethics and integrity across Vertex's global organization. Be a key member of this dynamic team in Vertex's growing Department.

Responsibilities:

  • Evaluate and enhance Company policies, SOPs, guidelines, and associated internal communication and training plans related to key areas of vulnerability relevant to global pharmaceutical companies.
  • Prepare and deliver compliance-related training, including new hire training, annual Code of Conduct training, policy-related training and scenario-based training on ethical decision-making.
  • Maintain high level of knowledge of current and emerging laws and regulations and recent enforcement actions and inform and educate business units with tailored communications.
  • Monitor field Commercial, Medical Affairs and Managed Markets transactions, activities, and processes and perform transactional monitoring to assess compliance with Company policies and procedures.
  • Manage and prioritize multiple complex projects; collaborating with multi-functional subject matter experts and stakeholders, as required.
  • Prepare and provide reports, presentations, materials, guidelines, and documents for employees, senior management and the Board of Directors.
  • Design new and enhance existing processes, controls, and systems, including the fair market value process, to effectively address and mitigate key risks.
  • Partner with OBIE and Legal colleagues across regions to address issues and identify opportunities for collaboration, alignment, process improvement and best practice sharing.
  • Draft company-wide communications related to Program initiatives or enhancements
  • Develop and demonstrate knowledge and competency to serve as a compliance and ethics subject matter expert.

#LI-RS1

Minimum Qualifications

  • Candidates should have strong academic credentials and at least 3-4 years of experience in a law firm or as a compliance professional in a global life sciences company.
  • Knowledge of laws and regulations relating to prescription pharmaceuticals.
  • Outstanding written communication skills, with an ability to cogently and succinctly communicate complicated legal and compliance principles in a straightforward, understandable manner.
  • Strong ability to communicate with all levels of management and employees, both in writing and verbally.
  • Possess sound, practical judgment in the interpretation and application of relevant laws, regulations, industry standards and Company policies.
  • Self-motivated and able to work with minimal supervision; able to exercise sound judgment in resolving matters of moderate complexity or escalating matters appropriately.
  • Strong analytical skills (including skills analyzing large quantities of data) and critical thinking as well as demonstrated attention to detail.
  • Ability to handle multiple tasks in a fast-paced environment is essential.
  • Strong interpersonal skills, with ability to forge strong relationships with all levels of the organization, under challenging conditions and effective influencing skills with the ability to drive change as it relates to implementing remedial actions.
  • Excellent project management skills with the ability to organize and manage multiple priorities while meeting deadlines.
  • Confidence and professionalism to handle difficult conversations and discretion on sensitive matters.
  • Demonstrated strong commitment to compliance, ethics and accountability.

Preferred Qualifications

  • International experience.
  • Extensive experience with Microsoft PowerPoint and Excel.
  • Fluency in additional language(s).

Company Information
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. We discovered and developed the first medicines to treat the underlying cause of cystic fibrosis (CF), a rare, life-threatening genetic disease. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases.

Founded in 1989 in Cambridge, Mass., Vertex today has research and development sites and offices around the world. For several consecutive years, Science magazine has named Vertex one of its Top Employers in the life sciences. For additional information and the latest updates from the Company, please visit www.vrtx.com.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.

Req ID
10914BR

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Posted 10/24/2018