The Pharmaceutical Compliance Forum

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EMPLOYMENT OPPORTUNITIES

 

SR. DIRECTOR BUSINESS ETHICS U.S. - Ipsen
Location: Cambridge, MA


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
The Senior Director, Business Ethics will support Ipsen's U.S. Business Ethics program and be responsible for assisting in the execution and continuous improvement of Ipsen's global business ethics program. The role will ensure compliance with Ipsen Global and local policies and all applicable standards, laws, and regulations, including, but not limited to the Food, Drug, and Cosmetic Act, U.S. Federal Anti-Kickback Statute, False Claims Act, Federal Physician Payments Sunshine Act (Open Payments), Foreign Corrupt Practices Act, and HIPAA.

The role will involve the management and execution of the various aspects of the U.S. Business Ethics program including but not limited to:

  • Policy and Procedural document maintenance and creation
  • Training and education creation and delivery
  • Internal monitoring development and execution
  • Supporting lines of communication with stakeholders
  • Enforcing standards through investigation and publicized guidelines
  • Assessing compliance risk and implementing mitigating/corrective actions

Essential Functions
Responsibilities:

  • Provide business ethics support and guidance to the U.S. Oncology, Neurology, and/or Rare Disease brand and field teams, U.S. Medical/HEOR, Value & Access, and Transparency teams.
  • Assist the VP Business Ethics NA to prepare the annual business ethics work plan based upon a comprehensive compliance risk assessment.
  • Provide support to enhance and develop Ipsen U.S. Business Ethics policies, standards and procedures; work with members of Ipsen's businesses to understand the policies, standards, and procedures and how to implement business initiatives within that context.
  • Develop and deliver business ethics training to Ipsen stakeholders based upon assessing internal and external environmental developments and risk areas.
  • Develop and execute monitoring activities related to Ipsen's businesses and help ensure compliance with applicable internal and external requirements, including the evaluation of business activities, their respective approval and documentation.
  • Support the business with the operational Fair Market Value (FMV) efforts in connection with the engagement of HCPs.
  • Maintain a current working knowledge of various laws, regulations, and industry guidance that affect the Global Business Ethics program, including: Federal Sunshine Act (Open Payments), State Laws (restrictions, licensures, and reporting), Industry Guidance (PhRMA Code), and Federal Regulations (Anti-Kickback Statute, FDCA, HIPAA, etc.)
  • Work with the VP Business Ethics NA to coordinate the development and implementation of Ipsen's internal business ethics processes to enhance and streamline policy, communications, auditing, risk assessment, monitoring and investigation activities with a view toward global harmonization, automation and reporting.
  • Work with the Business Ethics Global Investigations Director to investigate potential violations of U.S. policies, standards or procedures raised to Business Ethics.
  • Support and cascade Ipsen's (Global) Business Ethics Program within the U.S. and collaborate with the Global Business Ethics team on Global initiatives
  • Proactively identify potential areas of compliance vulnerability and risk.
  • Implement corrective/mitigation action plans and oversee operational risks.
  • Act confidentially with urgency and diligence when responding to alleged violations of company policy, rules, regulations, thoroughly evaluate and recommend the proper course of action.
  • Participate in applicable meetings that require Business Ethics to be present.

Travel: Approximately 25% domestic and international

Qualifications
Education and Experience:

  • Bachelor of Arts and/or Bachelor of Science mandatory
  • MBA, JD, or professional degree is preferred
  • Minimum of 7-10 years of healthcare compliance experience
  • Minimum of 5 years in-house experience with a biotech or pharmaceutical company
  • A demonstrated aptitude and knowledge of the life sciences business model and commercial organization.

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

  • Demonstrated knowledge and understanding of the Food, Drug, and Cosmetic Act, U.S. Federal Anti-Kickback Statute, False Claims Act, Foreign Corrupt Practices Act, and HIPAA.
  • Demonstrated knowledge and experience with the Federal Physician Payments Sunshine Act (Open Payments) and State Laws (restrictions, licensures, and reporting)
  • Broad pharmaceutical compliance experience interacting with field teams (sales, educators), marketing brand teams, Medical Affairs/HEOR, and Market Access.
  • Highest personal integrity and ethics; exceptional sense of judgment and discretion.
  • Ability to handle highly confidential and sensitive information with discretion.
  • Business and project management experience highly preferred.
  • Demonstrated skills in managing tight deadlines and multiple priorities.
  • Ability to work independently.
  • Superior time management and prioritization skills.
  • Ability to see the bigger picture; well-organized and focused on results.
  • Strong interpersonal and communication skills for negotiating deliverable, timelines and effective collaboration.
  • Ability to build consensus and respectfully driven decision making while gaining agreement regardless of issue popularity.
  • Proven ability to thrive in a fast-paced, deadline-driven environment and to partner towards a common agreed upon goal.

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.

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.

 Apply here
Posted 3/26/2020

ASSOCIATE DIRECTOR - COMPLIANCE MONITORING, AUDIT AND RISK MANAGEMENT - Jazz Pharmaceuticals
Location: May be based in Philadelphia, PA or Palo Alto, CA


Brief Description:
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.

The Associate Director, Compliance Monitoring, Audit & Risk Management is responsible for developing and executing against the Jazz Pharmaceuticals, Inc. (Jazz) annual compliance monitoring plan. This position will regularly monitor field activities, conduct monitoring and audits of company records and programs, execute against Jazz's Risk Assessment and Mitigation Process (RAMP) program, and have responsibility for remediation related to compliance findings and allegations of non-compliance with Company policy. The position will prepare dashboards, reports, and presentations summarizing monitoring and auditing findings and remediation for audiences ranging from Business Partners,Jazz Leadership and 3rd parties. Finally, the position will support efforts related to analytics and innovative approaches to monitoring.

Primary Responsibilities

  • Conducts live field monitoring of Commercial and Medical Affairs activities.
  • Conducts transactional monitoring of records and systems including but not limited to: patient assistance programs, arrangements and interactions with Independent Charity PAPs, expense reporting, medical information requests, and consulting and advisory engagements.
  • Prepares reports, presentations, and dashboards for numerous audiences, including Jazz Leadership, that summarize monitoring and auditing findings and remediation.
  • Supports Jazz's RAMP process and prioritizes monitoring activities and mitigation plans based on potential risks associated with Jazz's products and with applicable Federal health care program requirements.
  • Manages the remediation and corrective action process for the Compliance team.
  • Conducts ad-hoc monitoring and auditing as necessitated by investigations and Jazz's Corporate Integrity Agreement.
  • Supports the development and enhancement of data analytics and use of innovative technology to expand and advance monitoring capabilities.
  • Contributes as needed to the preparation of Government reporting, including reports required by the Corporate Integrity Agreement, Open Payments, and state law monitoring and reporting.
  • Develops and maintains updated knowledge and understanding of Jazz's products, industry regulations and guidelines, and Company policies and standard operating procedures.

Required Knowledge, Skills, and Experience

  • Minimum of 7 years' of healthcare compliance monitoring or auditing experience with a pharmaceutical/biopharmaceutical company or within the life sciences industry is required.
  • 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, HIPAA, Open Payments, and relevant industry guidance, specifically PhRMA Code on Interactions with Healthcare Professionals is required.
  • Experience working under a Corporate Integrity Agreement is preferred.
  • Ability to manage multiple projects to completion on-time, meeting internal and external deliverables with high degree of accuracy.
  • Ability to interact with Jazz employees at all levels of the organization.
  • Team player with strong interpersonal skills.
  • Strong oral and written communication skills.
  • Ability to work collaboratively and independently as the circumstances require.
  • Self-motivated and detail-oriented.
  • Highest level of ethics and personal integrity.
  • Position may be based in Philadelphia, PA or Palo Alto, CA.

Required/Preferred Education

  • Bachelor's degree required.

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, sexual orientation, gender-identity, national origin, disability status, protected veteran status, or any characteristic protected by law.

 Apply here
Posted 3/24/2020

SENIOR MANAGER, COMPLIANCE OPERATIONS - Jazz Pharmaceuticals
Location: May be based in Philadelphia, PA or Palo Alto, CA


Brief Description:
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.

The Senior Manager, Compliance Operations is a critical role responsible for managing the day-to-day operations of the Compliance Department. The role will collaborate with all members of the Department to ensure an integrated approach to Compliance. This position will manage tasks and milestones associated with the annual Compliance Work Plan, Jazz's Corporate Integrity Agreement and support additional projects that affect the success of the execution of the Compliance Department's strategic business priorities. The role will involve the management of a number of key Compliance activities and systems including Fair Market Value, the Compliance Department intranet site, and the Compliance Operations mailbox. Additional responsibilities may flow from 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 and give presentations to Compliance Department management, the Compliance Committee and the Board of Directors that discuss the status and progress of such projects.

Primary Responsibilities
The Senior Manager, Compliance Operations serves as the Compliance Program Manager, and is responsible for the day-to-day management of the operations of the Compliance Department and oversight of certain Compliance activities and projects as determined by the Chief Compliance Officer and the Deputy Chief Compliance Officer, including, but not limited to:

  • Tracks and reports on the status of Compliance Department activities against the annual Compliance Work Plan.
  • Manages project plans and provides direction to Compliance Department personnel to ensure that all key deliverables related to Jazz's Corporate Integrity Agreement are timely accomplished.
  • Oversees the Compliance Department budget, including the management of monthly accruals, forecasting expenditures, and establishing practices that promote and support responsible spending.
  • Oversees the engagement and management of suppliers engaged by or acting on behalf of the Compliance Department including processes related to contracting, vendor setup, invoicing, and project closure.
  • Manages Jazz's Fair Market Value process and periodic updates to Fair Market Value rate cards, processes, and systems.
  • Develops and implements efficient systems, processes, and technologies to enhance operational tasks.
  • Plans, sets the agenda, and tracks completion of action items for key Compliance Department meetings.
  • Manages the Compliance Department intranet website to ensure that content is up-to-date and easily accessible by Jazz employees.
  • Manages the Compliance Operations mailbox and triages all messages to ensure they are timely addressed, tracked, and trends identified for reporting purposes.
  • Assists the Deputy Chief Compliance Officer and the Chief Compliance Officer in the preparation of regular reports and presentations for Company Leadership, Jazz's Compliance Committee and the Board of Directors.
  • Assists with building internal awareness of the Compliance Department and accessibility to Compliance teams and resources.
  • Participates in other Compliance Department projects as determined by the Chief Compliance Officer or Deputy Chief Compliance Officer.

Required Knowledge, Skills, and Experience

  • Minimum of 5 years of healthcare compliance experience with a pharmaceutical/biopharmaceutical or life sciences company is required.
  • Familiarity with the Federal Anti-Kickback Statute and Federal Civil False Claims Act, Food and Drug Administration rules and regulations regarding the promotion of pharmaceuticals, Health Insurance Portability and Accountability Act, Open Payments, and relevant industry guidance, including the PhRMA Code on Interactions with Healthcare Professionals is required.
  • Strong interpersonal, strong oral and strong written communication skills are required.
  • Strong organizational skills including attention to detail are required.
  • Experience working under a Corporate Integrity Agreement is preferred.
  • Program Management experience; previous successful initiation, planning, design, execution, monitoring, controlling and closure of multiple projects is required.
  • Ability to develop and effectively implement a project plan and ensure adherence to schedules, work plans, budget and performance requirements is required.
  • Ability to prepare presentations for use at all levels of the Company is required.
  • Ability to think critically, strategically and to quickly analyze complex compliance circumstances and problems.
  • Ability to prioritize competing demands and manage a heavy workload.
  • Ability to manage external consultants and vendors engaged to assist in conducting compliance projects.
  • Ability to work collaboratively and independently as the circumstances require.
  • Position may be based in Philadelphia, PA or Palo Alto, CA.

Required/Preferred Education

  • Bachelor's degree required.

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, sexual orientation, gender-identity, national origin, disability status, protected veteran status, or any characteristic protected by law.

 Apply here
Posted 3/24/2020

DIRECTOR, SENIOR COMPLIANCE COUNSEL - Karyopharm Therapeutics
Location: Newton, MA


Role Overview:
Is your New Year's resolution to find a new professional challenge with a fun, high energy and patient-focused organization? Karyopharm Therapeutics is looking for an experienced attorney to join us as Director, Senior Compliance Counsel. This position will report to the Chief Compliance Officer, and will be located at our headquarters in Newton, MA.

The Director, Senior Compliance Counsel will serve as the legal reviewer for advertising and promotional materials as well as materials used by Medical Affairs. This role will serve as a legal subject matter expert across areas of healthcare regulatory law, product liability and privacy laws. Maintaining a focus on the external environment, the Director, Senior Compliance Counsel will track and communicate to the organization significant decisions, legislation and regulatory rulings that may affect the company.

Additionally, this role will serve as a compliance business partner, providing proactive compliance guidance and support across key functions within the business. This role will assist in the development and implementation of compliance training and initiatives. This role will have high visibility throughout the organization, supporting core business activities and cross functional teams as assigned. The successful candidate in this role will develop strong and positive working relationships with colleagues at all levels, particularly within the home office and field-based Commercial and Medical Affairs organizations. This role will also lead and support a variety of cross functional projects as assigned.

Role Responsibilities:

  • Legal Reviewer for Promotional Advertising Review Team
  • Legal Reviewer for Medical Materials Review Team
  • Legal advisor in areas of healthcare regulatory law, fraud and abuse laws, privacy laws and other areas as assigned.
  • Compliance business partner supporting key business functions
  • Cross functional project participation and/or leadership
  • Compliance program support (e.g. training, monitoring, policies)
  • Other tasks as assigned.

Role Qualifications:

  • Juris Doctorate Required
  • MA Bar admission or eligibility for in-house counsel admission
  • Advertising and promotional materials review experience required
  • 5-10 years legal experience in Pharmaceutical or Biotech industry experience preferred
  • Prior compliance experience preferred

 Apply here
Posted 3/11/2020

HEAD OF GLOBAL RISK ASSESSMENT & MONITORING - Alexion
Location: New Haven/Boston
Date: January 29, 2020


Position Summary
The Head of Global Risk Assessment & Monitoring is responsible for the development and implementation of preventative and proactive compliance assessment, analytics and monitoring activities for all activities and transactions. This role will be responsible for developing and implementing an annual and periodic risk assessment approach with corresponding processes and tools to support these assessments. This role also determines the activities, sources, and methods to monitor compliance with business practices, policies, laws and regulations. This position will be responsible for supporting Alexion's overall global Compliance Program by taking a consultative and business oriented approach and modeling a culture of compliance through leadership of the Global Risk Assessment & Monitoring function. This individual will be responsible for assessing resources and building a team to support the various assessment, analytics and monitoring activities. The role reports directly to the Chief Compliance Officer and contributes to Alexion's overall global compliance strategies.

Job Duties & Responsibilities
Develops, builds, and implements globa risk assessment, analytics and compliance monitoring programs and solutions for all activities and transactions, focused on HCP engagements, external funding activities, and third party transactions to ensure compliance with policies and procedures, including Alexion's global Anti-Bribery/Anti-Corruption (ABAC) Compliance Program, and various other relevant laws and regulations. Among other things, the role is accountable forthe following:

  • Identifying global risk areas by assessing the execution of Alexion's Compliance Program through data analysis and risk assessments.
  • Aggregate data from various systems, including Alexion's ABAC Approval System, SAP, Concur, VEEVA, among others tools and systems, to monitor risks globally across the enterprise. Collaborating with Data Scientists and Data Analyts to develop requirements for Compliance dashboards to assist in the reporting of potential compliance risk areas to senior management, Compliance Committees, and leadership teams.
  • Establishing mechanisms to proactively monitor compliance activities based on consultation with business partners on emerging issues and trends.
  • Implementating a global compliance monitoring framework and program across the business operations.
  • Partnering with relevant stakeholders across the business to ensure an integrated approach to global risk monitoring.
  • Performing ad hoc monitoring, as needed, to support compliance activities and to ensure compliance with relevant laws and regulations.

Accountable for:

  • Development and implementation of risk asessement and compliance monitoring programs and solutions for all business operations.
  • Development of processes and resources to support the collection of data and analytics to support real-time monitoring.
  • Partnership with internal teams for the ongoing management, proactive improvement, and monitoring of compliance programs.
  • Utilizing tools, resources, and data analytics to develop key insights across the organization.

Essential Qualifications

  • 12-15 years of relevant experience in a monitoring program role within a Compliance, Legal, Audit, or Risk function;
  • Prior Biotechnology/Pharmaceutical industry experience is preferred;
  • Excellent communication skills both written and verbal;
  • Excellent problem solving and analysis skills, including data analysis tools;
  • Excellent interpersonal skills with demonstrated track record and ability to drive results as an effective a team member and leader;
  • Strong sense of ethics and responsibility; and
  • Ability to travel as required to meet business needs.

Preferred Qualifications

  • Prior experience with data visualization and analytics software such as Qlik Sense or Tableau is helpful;
  • Basic understanding of data analytics programming languages (e.g. Python, SQL)
  • Working knowledge of data modeling and database management systems (DBMS)
  • Demonstrated ability to work collaboratively with other Compliance leaders, and with external partners; and
  • Flexibility and ability to adapt to changing conditions.

 Apply here
Posted 2/26/2020

POLICY & TRAINING MANAGER - Exelixis
Location: Alameda, CA US
Divisions: G&A
Job Code: TBD
FLSA Status: Exempt
Reports To: Lori Parenti


SUMMARY:
The Exelixis Compliance Program sets policies and procedures, conducts training, and continually monitors and audits operational activities at the company in connection with a variety of laws and regulations, including but not limited to US healthcare laws governing interactions with healthcare professionals (HCP), FDA regulations, and privacy laws. The Compliance Training Manager will assist in maintaining and enhancing Exelixis' written policies, procedures and work instruction, and the various forms of training devised to educate the Exelixis workforce accordingly. More specifically, this individual will be responsible for supporting training project and program deliverables that align to our compliance training plan and related communications. Essential business partners for this role are Commercial, Medical Affairs, Quality Assurance, Finance, Legal and HR.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Evaluate policies and procedures, considering how to maximize the effectiveness of their content so they are understandable and accessible to the appropriate audience
  • Contribute to the technical writing and standardization of policy and procedural documents
  • Support ongoing development and design of our Business Conduct Manual (BCM) and related training and communication
  • Contribute to our annual training plan development and implementation and ongoing improvement
  • Proactively identify and address training gaps that address compliance issues/risks
  • Assist in compliance training strategy to support online and live training events
  • Pull through internal training initiatives (e.g., Compliance Corner Newsletters, Compliance Champion engagement)
  • Leverage internal/external survey platforms to measure training success and gather feedback
  • Support our Learning Management System (ComplianceWire) for recording, reporting and tracking compliance training
  • Vendor management support
  • Respond to inquiries sent to internal compliance mailbox
  • As assigned, assist with other department duties and/or projects

SUPERVISORY RESPONSIBILITIES:

  • None

EDUCATION/EXPERIENCE:

  • BS/BA degree in related discipline
  • 3-5 years of relevant professional experience
  • CPA, CIA, CFE, CCEP certification is a plus
  • Technical writing experience demonstrated by writing samples
  • Experience in biotech/pharmaceuticals/healthcare - preferred but not required

KNOWLEDGE/SKILLS/ABILITIES:

  • Ability to create engaging content that supports adult learning principles
  • Passion for presenting and public speaking
  • Ability to work independently and be a confident collaborator
  • Excellent verbal and technical writing skills
  • Strong organizational (detail oriented), project management, and problem-solving skills
  • Ability to handle multiple tasks, prioritize appropriately
  • Must be responsible, conscientious, and professional
  • Dedication to quality and the highest professional standards
  • Must be a self-starter and quick learner
  • Advanced computer skills (e.g., Microsoft Office Suite (Word, Excel, PowerPoint), InDesign, Acrobat)

JOB COMPLEXITY:

  • Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. May also work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
  • Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.
  • Networks with key contacts outside own area of expertise.

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 2/13/2020

CORPORATE COMPLIANCE LEAD - Spark Therapeutics, Inc.
Location: Philadelphia, PA
Title of Position Reporting To: Head of Corporate Compliance
Department: Corporate Compliance
Job Level: M4
FLSA (Exempt or Non-Exempt): Exempt

Primary Duties
The Corporate Compliance Lead provides compliance advice and guidance to the Corporate Compliance department and to Spark Therapeutics, Inc. ("Spark" or "the Company") global research and development ("R&D"), clinical, and commercial business units regarding the Company's Code of Conduct and Business Ethics ("Code"), Corporate Compliance policies and standards, and other compliance issues and inquiries. The Corporate Compliance Lead supports compliance with laws and regulatory requirements of local, state, and federal agencies, as well as Spark's compliance policies and procedures. In collaboration with the Corporate Compliance team, this role establishes and implements the Corporate Compliance Program to ensure its effectiveness in promoting and enforcing the Code and compliance policies and procedures, as well as preventing, detecting, and correcting non-compliance with the Code, compliance policies and procedures, and applicable laws and regulations. This role advises and supports compliance investigations to ensure that such investigations are conducted in a timely, objective and comprehensive manner and appropriate corrective action is implemented in accordance with the Company's compliance policies and procedures. The Corporate Compliance Lead collaborates with key stakeholders across cross-functional business units to ensure that the Code and Corporate Compliance Program are implemented appropriately and enforced consistently. This role interacts with and advises Functional Heads and the Senior Leadership Team ("SLT") on compliance matters that affect the success of the Company and the execution of the Company's strategic business priorities. The Corporate Compliance Lead, in collaboration with the Corporate Compliance team, develops, updates, and implements Corporate Compliance Program strategies, policies and procedures, oversight processes, and program controls. This role participates in the Corporate Compliance training program to deliver timely and targeted education to Spark business units. The Corporate Compliance Lead monitors global compliance, and regulatory matters throughout the pharmaceutical/biotech industry, as well as regulations and guidances of local, state, and federal agencies, to identify those issues, changes, and emerging risks that may affect the Company and to assist with implementing modifications, as needed, to the Corporate Compliance Program and/or Spark's business operations.


Responsibilities

Compliance Program Monitoring and Risk Mitigation

  • Implement Spark's Corporate Compliance Program. Ensure that compliance policies, procedures, and training are developed, adopted, published, and communicated to all employees, and other relevant stakeholder to prevent illegal, unethical, non-compliant and/or improper conduct.
  • Maintain Corporate Compliance policies and procedures to ensure currency with emerging laws, regulations, and trends of local, state, and federal agencies and applicable changes relevant to legal and compliance risks throughout the pharmaceutical/biotech industry.
  • Periodically review and update the Code to ensure continued relevance in providing guidance to employees, management, senior leadership, and external individuals and entities, and to deliver required training on the Code, as needed.
  • Actively monitor regulatory agencies and the pharmaceutical/biotech industry for best practices, emerging trends, and potential risks in corporate compliance.
  • Champion an ethical culture in which compliance and business objectives are mutually reinforcing and the Corporate Compliance Program is well integrated into the Company's business activities.
  • Partner with Functional Heads and members of the SLT to maintain and enhance a strong culture of compliance, including personal accountability at all levels in the organization, with a spirit of partnership and positive problem-solving.
  • Evaluate issues and respond to inquiries regarding application of the Code and related policies and procedures. Advise and guide Functional Heads to resolve any related challenges.
  • Partner with the Corporate Compliance Operations Leader regarding monitoring and auditing activities relative to the Code and compliance policies and procedures. Advise on appropriate corrective action in response to irregularities identified from compliance monitoring and auditing activities.
  • Ensure that compliance issues or concerns are appropriately evaluated, investigated, and resolved, and any remediation is conducted using an effective and consistent system of discipline to address misconduct.
  • Partner with the Corporate Compliance team and/or Legal to facilitate, track, and support, where appropriate, any investigations of potential non-compliance with the Code or the Corporate Compliance Program. As needed, assist with the implementation and ongoing monitoring of any corrective action.
  • Assist the Head of Corporate Compliance by implementing periodic risk assessments, audits, and reporting procedures to identify potential areas of compliance vulnerability and risk. Implement preventative and corrective action plans to mitigate identified risks.
  • Provide reports on a regular basis, and as directed or requested by the Head of Corporate Compliance, to inform management regarding the operation and progress of the Corporate Compliance Program.

Compliance Advisement to Legal, Business Units, and Senior Leadership
Business Units

  • Partner with, support, and advise cross-functional business units regarding the mitigation of risk assessment activities to optimally manage and avoid issues with compliance risk.
  • Serve as the Corporate Compliance liaison to Functional Heads and cross-functional teams to address compliance inquiries and challenges, design and implement customized policies and procedures, and achieve business goals in compliance with relevant laws and regulations and Corporate Compliance policies and procedures.
  • Provide compliance advice and insight to Functional Heads and cross-functional teams regarding various R&D and commercial initiatives. Participate as the Corporate Compliance representative on cross-functional teams to advise on the full spectrum of activities from concept proposal to final execution.
  • Advise Functional Heads and cross-functional teams on general or specific compliance legal matters related to the Company's business strategies and initiatives.
  • Create, maintain, and evaluate appropriate reporting related to the Corporate Compliance Program. Develop and present, as needed, reports and presentations to Functional Heads and cross-functional teams.
  • Support other compliance projects and initiatives, as requested, by the Head of Corporate Compliance to provide targeted solutions to Functional Heads and cross-functional teams.

Corporate Compliance Policy Development, Monitoring, and Training

  • Design and implement enhancements to the Corporate Compliance Program and promote awareness of, conduct training for, and ensure adherence to the Code and related policies, procedures, and guidelines.
  • Develop, publish, maintain, and interpret compliance policies and procedures as may be appropriate to fully implement the provisions of the Code and related compliance policies and procedures and/or to meet the requirements of applicable statutes, regulations, and business standards.
  • Collaborate with the Corporate Compliance team to develop new policies and training in response to changes concerning laws, regulations, and guidances that affect Corporate Compliance policies and procedures.
  • Collaborate with the Corporate Compliance team to develop and revise, as needed, risk assessment plans and auditing and monitoring protocols.
  • Monitor and present emerging trends in compliance training to the Corporate Compliance team to ensure that the compliance training program is dynamic and fully reflects leading practices for content development and delivery formats for compliance training.
  • Partner with the Corporate Compliance Operations Leader to prepare and deliver compliance training to all employees to ensure understanding of and adherence to the Corporate Compliance Program and related compliance policies and procedures.

Compliance and Business Ethics Helpline

  • Participate in investigations arising from reports submitted to the Compliance and Business Ethics Helpline regarding alleged violations related to the Code and Company policies or procedures.
  • Advise and guide on any violations that require remediation, recommend appropriate corrective action, and participate in discussions with Functional Heads, Legal and/or HR to implement remediation plans. As needed, support ongoing monitoring to ensure full compliance with Company policies and procedures.

Communications to Senior Leadership and Board of Directors

  • Design, develop, and present reports and presentations to the cross- functional teams and SLT, CMT, and BOD or assist the Head of Corporate Compliance with these communications.
  • Bachelor's Degree in related field required (e.g., life sciences, law, public policy, business management, training and development)
  • Graduate-level degree required (e.g., JD, MBA, MS, CPA, or related discipline)
  • Generally, 10 or more years of experience in the biotech/biopharma/pharma industry with pharmaceutical products intended for human use or with other life-science regulated industries. Strong experience in global healthcare compliance or legal department(s) with a demonstrated deep understanding of the complex functions of a pharmaceutical organization and the associated legal, regulatory, and compliance matters of the industry.
  • 5 years or more of experience preferred with developing and monitoring a corporate compliance program and associated policies, procedures, and training; conducting and resolving internal investigations; and partnering effectively with cross-functional teams to advise on compliance matters and challenges.
  • Deep and well-rounded knowledge of applicable federal, state, and local laws and regulations that affect Spark's Corporate Compliance Program (e.g., OIG Compliance Program Guidance for Pharmaceutical Manufacturers, PhRMA Code on Interactions with Healthcare Providers, industry guidance documents, CIA trends, Stark Law, HIPAA, regulations regarding the promotion of marketed products, EFPIA and the False Claims Act, and Anti-Kickback Statutes).

Key Skills, Abilities, and Competencies

  • Excellent organizational, advocacy and facilitation skills to effectively implement the Corporate Compliance Program and manage change, as needed, and to engage others to implement changed processes to ensure ongoing compliance with the Corporate Compliance Program
  • Excellent written and verbal communication skills; excellent public speaking/presentation skills and experience with designing and presenting training materials
  • Demonstrated ability to operate in an entrepreneurial, responsive, and collaborative style focused on advancing Spark's business priorities while ensuring adherence to the Company's compliance programs and projects
  • Proven experience building and cultivating relationships with key partners and stakeholders across all organizational levels
  • Strong ability to build credibility and communicate effectively with individuals and teams in Spark business units and to inspire confidence and support for compliance initiatives
  • Strong collaboration, critical thinking and negotiation skills to influence cross-functional teams in problem resolution and to direct decisions toward desired outcomes (e.g., resolution of compliance investigations)
  • Ability to resolve compliance challenges across the organization while demonstrating discretion, confidentiality, and respect for colleagues • Proficient interviewing and interrogation skills that achieve effective outcomes while eliciting trust and demonstrating courtesy and respect
  • Experience and confidence with counseling regarding compliance matters
  • Impeccable ethics and proven abilities to reflect, support and promote Spark's values

Complexity and Problem Solving

  • Ability to think critically, strategically and quickly analyze complex compliance circumstances and problems
  • Demonstrated ability to synthesize information from diverse sources, develop options for resolution, make decisions that are rational and based on sound evidence, and determine an action plan, as needed
  • Ability to oversee projects and successfully complete them in an organized, efficient, and effective manner
  • Ability to provide sound compliance-related advice and recommendations
  • Proven ability to advise on complex compliance-related matters and communicate information concisely and effectively to cross-functional business teams
  • Ability to work in a dynamic, fast-paced environment with shifting priorities and to interact successfully in a global company with a culturally diverse workforce

Internal and External Contacts

Senior Leadership and BOD

  • Design, develop, and present reports and presentations to the SLT, CMT, and/or BOD or assist the Head of Corporate Compliance with these communications.

Corporate Compliance Management Team

  • Assist the Head of Corporate Compliance and Compliance team members, as needed, with assigned activities to support Corporate Compliance matters, policies, programs, and initiatives.

Cross-functional Teams, Functional Heads, and Stakeholders

  • Advise, guide, and collaborate with business units throughout the Company and lead discussions to respond to inquiries, identify needs and challenges, design customized solutions, and implement action plans regarding the Corporate Compliance Program.

External Law Firms

  • Seek and incorporate, as appropriate, ad hoc advice related to the Corporate Compliance Program and other compliance matters.

Third-party Service Providers/External Vendors

  • Manage third-party service providers for various programs and/or services, as needed.

Other Job Requirements

  • Domestic and international travel is required on a per project basis.

 Apply here
Posted 1/31/2020

E&C CORPORATE PARTNER - UCB
Location: Smyrna, Georgia, United States
Job Function: Legal
Job ID: 66182

Help us transform patients' lives.
At UCB, we put our heart, soul and skills into making a difference for people living with significant unmet needs. Working together, we blend the best of our talents to deliver thoughtful solutions that patients value. Will you join us in this pioneering adventure?

To strengthen the Ethics and Compliance Team based in Smyrna, Georgia or Brussels, Belguim, we are looking for a talented individual to fill the position of: ETHICS AND COMPLIANCE CORPORATE PARTNER.

The Ethics & Compliance (E&C) Corporate Partner will work with global teams (Mission, Centers of Excellence, Functions) to implement effective Ethics & Compliance programs, including prospectively identifying ethics and compliance risks and actively preparing for future business needs. The E&C Corporate Partner acts as the E&C contact for assigned business teams and advise global business colleagues on E& C related-matters, driving integration of E&C into their strategies and activities. This role may support design of global solutions as subject matter expert. This individual can work in the Headquarters in Brussels, Belgium or Smyrna, Georgia.


You like to work in an environment where you can:

  • Identify key upcoming needs from the business, trends in the industry and code developments, determining if E&C alignment or solutions already exist or need to be adapted to address such needs.
  • Work with relevant stakeholders, develops, implements, coordinates, and delivers awareness education, policies and procedures training, and other necessary training programs to internal and external business partners.
  • Actively engage the leadership team in each applicable global team in driving the tone from the top in integrity and leveraging communication cascade to the organization to maintain a high level of awareness in ethical business conduct.
  • Champion speak-up, transparency and a culture of integrity throughout the organization.
  • Facilitate flow of communication within respective E&C networks (e.g., corporate leads; Neurology and Immunology).

You will contribute by:

  • Maintaining thorough knowledge of all industry codes, and in cooperation with Legal, of all applicable laws and regulations. Monitor and follow up of key developments that would impact the business.
  • Advising the business regarding existing and future provisions, ensuring appropriate planning and preparation of remediation actions if needed.
  • Providing advice and guidance to globally-led activities and strategies on ethics & compliance matters, including identified risk areas and interactions with healthcare professionals, government officials, healthcare institutions, patients and patient groups.
  • Co-creating and collaborating on business initiatives to foster innovation and creation of meaningful solutions for patients while ensuring integrity and ethical principles are respected.

Interested? For this position, you'll need the following education, experience and skills:
Minimum Qualifications:

  • Bachelor's Degree
  • 5 + years of experience in the pharmaceutical industry.
  • Proficiency in Healthcare Compliance requirements including self-regulated industry codes.

Preferred Qualifications:

  • Master's Degree preferred.
  • Prior management/supervisory experience preferred.
  • Experience (direct or indirect - confronted and operated) in healthcare compliance.

About Us
At UCB, we come together every day to work, laser-focused, on a simple question: How will this create value for people living with severe diseases? By putting patients at the heart of everything we do, our approach - from discovery to development to delivery - is continuously transformed and designed around patient needs and their journey.

With a team of approximately 7,500 employees worldwide operations in more than 40 countries, we are a global biopharmaceutical company investing more than a quarter of our revenue in cutting-edge scientific research. We are focused on addressing chronic, neurological, immunological, and bone diseases. We are looking for people with passion and empathy who develop a real understanding of patient's needs and can deliver thoughtful solutions to decisionmakers across the heath care ecosystem.

Curious to know more? Please visit our website www.ucb.com.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.

 Apply here
Posted 1/31/2020

E&C OPERATIONS PARTNER (Monitoring and Analytics) - UCB
Location: Smyrna, Georgia, United States
Job Function: Sales
Job ID: 66170

Help us transform patients' lives.
At UCB, we put our heart, soul and skills into making a difference for people living with significant unmet needs. Working together, we blend the best of our talents to deliver thoughtful solutions that patients value. Will you join us in this pioneering adventure?

To strengthen the Ethics and Compliance Team based in Smyrna, Georgia, we are looking for a talented individual to fill the position of: ETHICS AND COMPLIANCE OPERATIONS PARTNER.

The Ethics & Compliance (E&C) Operations Partner will work with E&C stakeholders to design, localize and/or operationalize E&C program elements to meet the needs of the assigned geography and as defined by E&C leadership. The E&C Operations Partner (OP) may be a generalist resource or may be specialized in specific elements of the compliance program depending on the needs of the assigned geography. This position will have a focus on Monitoring and Analytics.


You like to work in an environment where you can:

  • Promote a Culture of Ethics & Compliance; including, champion speak-up, transparency and a culture of integrity throughout the organization.
  • Work with the relevant E&C stakeholders to support implementation of compliance program elements.
  • Drive collaboration and creativity, support innovation, and actively contribute to the department and company.

You will contribute by:

  • Supporting the process for documenting the risk assessment and application of the assessment to compliance program elements as appropriate.
  • Creating and implementing training content including tracking as assigned
  • Supplementing the creation/revision/simplification of documented procedures. Supports initiatives, content creation, and dissemination.
  • Assisting with the execution of the annual monitoring plan, supports E&C report creation, provides analysis on trends and figures.

Interested? For this position, you'll need the following education, experience and skills:
Minimum Qualifications:

  • High School Diploma or equivalent
  • 5+ years of professional work experience in compliance, risk management, quality systems, or project management, or related function.
  • Excellent skills in organization, time management, planning, prioritization and attention to detail.

Preferred Qualifications:

  • Bachelor's Degree preferred.
  • Prior pharmaceutical industry experience preferred.
  • Ability to work effectively, collaboratively, and with sensitively in a highly matrixed organization

About Us
At UCB, we come together every day to work, laser-focused, on a simple question: How will this create value for people living with severe diseases? By putting patients at the heart of everything we do, our approach - from discovery to development to delivery - is continuously transformed and designed around patient needs and their journey.

With a team of approximately 7,500 employees worldwide operations in more than 40 countries, we are a global biopharmaceutical company investing more than a quarter of our revenue in cutting-edge scientific research. We are focused on addressing chronic, neurological, immunological, and bone diseases. We are looking for people with passion and empathy who develop a real understanding of patient's needs and can deliver thoughtful solutions to decisionmakers across the heath care ecosystem.

Curious to know more? Please visit our website www.ucb.com.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.

 Apply here
Posted 1/31/2020

SR. E&C BUSINESS PARTNER - MARKET ACCESS - UCB
Location: Smyrna, Georgia, United States
Job Function: Legal
Job ID: 66183

Help us transform patients' lives.
At UCB, we put our heart, soul and skills into making a difference for people living with significant unmet needs. Working together, we blend the best of our talents to deliver thoughtful solutions that patients value. Will you join us in this pioneering adventure?

To strengthen the Ethics and Compliance Team based in Smyrna, Georgia, we are looking for a talented individual to fill the position of: ETHICS AND COMPLIANCE LEAD - MARKET ACCESS.

The Ethics & Compliance (E&C) Affiliate Lead serves as the primary E&C contact for the Market Access team to implement effective E&C programs to identify and mitigate risks in scope (bribery & corruption, inappropriate promotion, Data Privacy and adherence to local industry regulations). The E&C Affiliate Lead is responsible for the design, localization and/or operationalization of ethics & compliance program elements and for advising business colleagues to drive integration of E&C into their plans & operations. The E&C Affiliate Lead will manage a team of E&C Partners to achieve stated goals.


You like to work in an environment where you can:

  • Work with the relevant stakeholders to ensure Affiliates maximize the effectiveness of the compliance program, ensuring that business leadership is committed to the highest ethical and compliance standards.
  • Drive risk assessments for Ethics & Compliance in the geographical area, ensuring that key stakeholders locally and regionally are informed of relevant risks and implementing remediation plans.
  • Ensure accountability is exercised through enforcement of our policies and applicable regulations; ensures allegation of misconduct are reported timely and discipline actions are implemented after investigations are done. Provides support during investigations as needed.
  • Actively engage the leadership team in each applicable Affiliate in driving the tone from the top in integrity and leveraging communication cascade to the organization to maintain a high level of awareness in ethical business conduct.

You will contribute by:

  • Maintaining thorough knowledge of all industry codes, and in cooperation with Legal, of all applicable laws and regulations. Monitors and follows up of key developments that would impact the business. Advise the business regarding existing and future provisions, ensuring appropriate planning and preparation of remediation actions if needed.
  • Actively participating in local industry trade association compliance (or related) committees, helping drive appropriate decision-making on key issues, integrating best practices and benchmarking into the overall approach.
  • Partnering with Area/Affiliate and Global Internal Audit (GIA) on audits, while maintaining full objectivity and independence from both parties.
  • Conducting (where applicable, in collaboration with E&C operations) due diligence activities of third parties with the Affiliate and associated compliance risk assessment and minimization (e.g. through training) of the pertaining high risk third parties.

Interested? For this position, you'll need the following education, experience and skills:
Minimum Qualifications:

  • Bachelor's degree required.
  • 5+ years of experience in the pharmaceutical industry.
  • Experience (direct or indirect - confronted and operated) in healthcare compliance.

Preferred Qualifications:

  • Master's degree preferred.
  • Prior management/supervisory experience preferred.
  • Experience working in a transnational and multicultural environment

About Us
At UCB, we come together every day to work, laser-focused, on a simple question: How will this create value for people living with severe diseases? By putting patients at the heart of everything we do, our approach - from discovery to development to delivery - is continuously transformed and designed around patient needs and their journey.

With a team of approximately 7,500 employees worldwide operations in more than 40 countries, we are a global biopharmaceutical company investing more than a quarter of our revenue in cutting-edge scientific research. We are focused on addressing chronic, neurological, immunological, and bone diseases. We are looking for people with passion and empathy who develop a real understanding of patient's needs and can deliver thoughtful solutions to decisionmakers across the heath care ecosystem.

Curious to know more? Please visit our website www.ucb.com.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.

 Apply here
Posted 1/31/2020

E&C BUSINESS PARTNER - MARKET ACCESS - UCB
Location: Smyrna, Georgia, United States
Job Function: Legal
Job ID: 66184

Help us transform patients' lives.
At UCB, we put our heart, soul and skills into making a difference for people living with significant unmet needs. Working together, we blend the best of our talents to deliver thoughtful solutions that patients value. Will you join us in this pioneering adventure?

To strengthen the Ethics and Compliance Team based in Smyrna, Georgia, we are looking for a talented individual to fill the position of: ETHICS AND COMPLIANCE BUSINESS PARTNER - MARKET ACCESS.

The Ethics & Compliance (E&C) Partner partners with Market Access and E&C Leadership to implement effective E&C programs to identify and mitigate risks in scope (bribery & corruption, inappropriate promotion, Data Privacy and adherence to local industry regulations). The E&C Partner is responsible for the design, localization and/or operationalization of ethics & compliance program elements and for advising business colleagues to drive integration of E&C into their plans & operations. The role may support design of global solutions as a subject matter expert.


You like to work in an environment where you can:

  • Work with the relevant stakeholders to ensure Affiliates maximize the effectiveness of the compliance program, ensuring that business leadership is committed to the highest ethical and compliance standards.
  • Drive risk assessments for Ethics & Compliance in the geographical area, ensuring that key stakeholders locally and regionally are informed of relevant risks and implementing remediation plans.
  • Actively engages the leadership team in each applicable Affiliate in driving the tone from the top in integrity and leveraging communication cascade to the organization to maintain a high level of awareness in ethical business conduct.
  • Implement (where applicable, in collaboration with E&C operations) robust monitoring plans based on the risk assessment; communicate results to leadership, analyze root causes and trends.

You will contribute by:

  • Maintaining thorough knowledge of all industry codes, and in cooperation with Legal, of all applicable laws and regulations. Monitors and follows up of key developments that would impact the business. Advise the business regarding existing and future provisions, ensuring appropriate planning and preparation of remediation actions if needed
  • Providing advice and guidance to the business on ethics & compliance matters, including identified risk areas and interactions with healthcare professionals, government officials, healthcare institutions, patients and patient groups.
  • Representing the Ethics & Compliance Team in/to internal and external governance bodies/authorities.
  • Conducting (where applicable, in collaboration with E&C operations) due diligence activities of third parties with the Affiliate and associated compliance risk assessment and minimization (e.g. through training) of the pertaining high risk third parties

Interested? For this position, you'll need the following education, experience and skills:
Minimum Qualifications:

  • Bachelor's degree required.
  • 5+ years of experience in the pharmaceutical industry.
  • Experience (direct or indirect - confronted and operated) in healthcare compliance.

Preferred Qualifications:

  • Master's degree preferred.
  • Experience working in a transnational and multicultural environment

About Us
At UCB, we come together every day to work, laser-focused, on a simple question: How will this create value for people living with severe diseases? By putting patients at the heart of everything we do, our approach - from discovery to development to delivery - is continuously transformed and designed around patient needs and their journey.

With a team of approximately 7,500 employees worldwide operations in more than 40 countries, we are a global biopharmaceutical company investing more than a quarter of our revenue in cutting-edge scientific research. We are focused on addressing chronic, neurological, immunological, and bone diseases. We are looking for people with passion and empathy who develop a real understanding of patient's needs and can deliver thoughtful solutions to decisionmakers across the heath care ecosystem.

Curious to know more? Please visit our website www.ucb.com.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.

 Apply here
Posted 1/31/2020

E&C OPERATIONS PARTNER - UCB
Location: Smyrna, Georgia, United States
Job Function: Legal
Job ID: 66141

Help us transform patients' lives.
At UCB, we put our heart, soul and skills into making a difference for people living with significant unmet needs. Working together, we blend the best of our talents to deliver thoughtful solutions that patients value. Will you join us in this pioneering adventure?

To strengthen the Ethics and Compliance Team based in Smyrna, Georgia, we are looking for a talented individual to fill the position of: ETHICS AND COMPLIANCE OPERATIONS PARTNER

The Ethics & Compliance (E&C) Operations Partner will work with E&C stakeholders to design, localize and/or operationalize E&C program elements to meet the needs of the assigned geography and as defined by E&C leadership. The E&C Operations Partner (OP) may be a generalist resource or may be specialized in specific elements of the compliance program depending on the needs of the assigned geography.


You like to work in an environment where you can:

  • Promote a Culture of Ethics & Compliance; including, champion speak-up, transparency and a culture of integrity throughout the organization.
  • Work with the relevant E&C stakeholders to support implementation of compliance program elements.
  • Drive collaboration and creativity, support innovation, and actively contribute to the department and company.

You will contribute by:

  • Supporting the process for documenting the risk assessment and application of the assessment to compliance program elements as appropriate.
  • Creating and implementing training content including tracking as assigned
  • Supplementing the creation/revision/simplification of documented procedures. Supports initiatives, content creation, and dissemination.
  • Assisting with the execution of the annual monitoring plan, supports E&C report creation, provides analysis on trends and figures.

Interested? For this position, you'll need the following education, experience and skills:
Minimum Qualifications:

  • High School Diploma or equivalent
  • 5+ years of professional work experience in compliance, risk management, quality systems, or project management, or related function.
  • Excellent skills in organization, time management, planning, prioritization and attention to detail.

Preferred Qualifications:

  • Bachelor's Degree preferred.
  • Prior pharmaceutical industry experience preferred.
  • Ability to work effectively, collaboratively, and with sensitively in a highly matrixed organization

About Us
At UCB, we come together every day to work, laser-focused, on a simple question: How will this create value for people living with severe diseases? By putting patients at the heart of everything we do, our approach - from discovery to development to delivery - is continuously transformed and designed around patient needs and their journey.

With a team of approximately 7,500 employees worldwide operations in more than 40 countries, we are a global biopharmaceutical company investing more than a quarter of our revenue in cutting-edge scientific research. We are focused on addressing chronic, neurological, immunological, and bone diseases. We are looking for people with passion and empathy who develop a real understanding of patient's needs and can deliver thoughtful solutions to decisionmakers across the heath care ecosystem.

Curious to know more? Please visit our website www.ucb.com.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.

 Apply here
Posted 1/31/2020

GLOBAL PROGRAM HEAD, VENDOR/THIRD PARTY COMPLIANCE - Otsuka Pharmaceuticals
Location: Can be located in either US, Japan or Europe

At Otsuka, we defy limitation, so that others can too.

We have an unwavering belief in doing more. In transcending expectations. In going above and beyond-under any circumstances-for patients, families, providers, and for each other. It's this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day.

We believe that the bigger the challenge, the bigger the opportunity. We are doing everything in our power to live up to our mission of creating new products for better health worldwide in two important therapeutic categories: neuroscience and nephrology.

Our culture is rooted in our Japanese heritage and almost 100-year history. Otsuka-people live by the core principles of Jissho - the achievement, completion, and discovery of truth; and Sozosei - pursuing that which only Otsuka is capable of delivering. We approach our business and overcome challenges through perseverance, unconventional thinking and humility.

Learn more about Otsuka Pharmaceutical Company on its global website at http://www.otsuka.co.jp/en. Learn more about Otsuka in the U.S. at www.otsuka-us.com.

Global Program Head, Vendor/Third Party Compliance

This role supports the Global CECO and wider Global Ethics & Compliance team and will be responsible for coordinating our global third-party vendor due diligence program, including setting standards and managing global risks associated with third parties.

**Please note that this position can be located in either US, Japan or Europe


Responsibilities include but not limited to the following:

  • Developing and implementing new global program for third party vendor due diligence and risk management, including vendor management activities and ensuring alignment with business and regulatory strategies
  • Developing consistent global standards for management of third parties.
  • Developing consistent contractual obligations for vendors with regard to compliance as well as Supplier Code of Conduct
  • Proactively identify areas of potential risk and develop proactive global and regional risk mitigation plans and manage issue resolution, incorporating learning to strengthen partnership processes
  • Actively leading large/ high impact third party diligences in specific regions when required, and provide ongoing support and expertise to regionally-based colleagues
  • Working with IT to establish appropriate technology platforms to support global compliance risk assessment efforts
  • Defining management reports/ dashboards and provide regular feedback to regional partners and global/ regional leadership teams

Qualifications:

  • BA or BS Degree required, relevant advanced degree preferred
  • Proficiency in multiple languages desirable
  • Minimum 10 years of experience with due diligence and audit procedures for a pharmaceutical/medical company, and ability to proactively identify risk of non-compliance in complex environments required.
  • Experience in all aspects of managing third party vendors; including contract negotiation, vendor performance management, preparing and evaluating RFPs, relationship management required.
  • Practical operational experience of working across disciplines and across multiple regions required.
  • Experience working within a global team framework and a multi-cultural environment
  • Efficiently/actively manages conflict in a tactful, diplomatic way, seeking effective solutions for all parties.
  • Able to manage both time and priority constraints and to manage multiple priorities simultaneously.
  • Capability to critically analyze complex and/or ambiguous information leveraging excellent analytical, technical and problem-solving skills.
  • Strong communication skills with the ability to express oneself clearly and concisely to a variety of audiences. Ability to understand/analyze/ synthesize and communicate to internal/external stakeholders.
  • Up to 20% domestic and international travel is required based upon business needs.

 Apply here
Posted 1/18/2020

GLOBAL PROGRAM HEAD, POLICY, LEARNING AND ENGAGEMENT - Otsuka Pharmaceuticals
Location: Can be located in either Rockville, MD or Princeton, NJ

At Otsuka, we defy limitation, so that others can too.

We have an unwavering belief in doing more. In transcending expectations. In going above and beyond-under any circumstances-for patients, families, providers, and for each other. It's this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day.

We believe that the bigger the challenge, the bigger the opportunity. We are doing everything in our power to live up to our mission of creating new products for better health worldwide in two important therapeutic categories: neuroscience and nephrology.

Our culture is rooted in our Japanese heritage and almost 100-year history. Otsuka-people live by the core principles of Jissho - the achievement, completion, and discovery of truth; and Sozosei - pursuing that which only Otsuka is capable of delivering. We approach our business and overcome challenges through perseverance, unconventional thinking and humility.

Learn more about Otsuka Pharmaceutical Company on its global website at http://www.otsuka.co.jp/en. Learn more about Otsuka in the U.S. at www.otsuka-us.com.

Global Program Head, Policy, Learning and Engagement

This role supports the Global CECO and wider Global Ethics & Compliance team and will be responsible for defining global policies and procedures, creating global training program curricula and content and setting enterprise-wide compliance communication standards and approach.

**Please note that this position can be located in either Rockville, MD or Princeton, NJ


Responsibilities include but not limited to the following:
The major responsibility of this position is high-level oversight of engagement execution including ensuring standardization, reporting global compliance audit and monitoring results, as well as maintaining and further strengthening relationships with global business stakeholders

  • Working with senior leadership to identify strategic priorities for updates to global policies and SOPs and assuming a lead role in creating or updating these policies/SOPs
  • Developing a governance approach, workflow approval, and updating process for all global compliance policies and procedures
  • Creating and managing a global compliance training curriculum consistent with business needs and regulatory requirements, and performing annual reviews and updates of program to optimize training standards, types, volume, access and adherence and learning outcomes
  • Managing and building a collaborative network of relationships with regional leaders to identify areas of risk or compliance knowledge deficiency and develop training program solutions
  • Creating a global communications program and implementation approach to support Ethics & Compliance initiatives, creating necessary content and managing logistics and execution
  • Communicating proactively with senior Ethics & Compliance leaders about issues and progress relating to global policies, training and communication initiatives

Qualifications:

  • BA or BS Degree required, relevant advanced degree preferred
  • Proficiency in multiple languages desirable
  • Minimum 10 years of legal, compliance or commercial experience, preferably in the healthcare or pharmaceutical industry is required.
  • Strong understanding of US, EU and international pharmaceutical laws (including fraud and abuse, anti-kickback/anti-bribery, FCPA, FCA) and implications for business strategy is required.
  • History of successful individual contribution to writing policies, procedures, training and guidance documents required.
  • Deep knowledge of best-in-class training methodologies and ability to leverage technology to deliver professional learning programs required.
  • Experience creating and executing awareness and communications strategies and tactics required.
  • Ability to work and deliver on deadlines while managing multiple projects and priorities effectively
  • Experience working across geographies and cultures, with a variety of personalities and working styles
  • Strong verbal and written communications skills - candidate must be skilled and comfortable with presentations to executive management
  • Confident in exercising independent judgment and identifying when to involve other team members with relevant subject matter expertise
  • Up to 20% domestic and international travel is required based upon business needs.

 Apply here
Posted 1/18/2020

GLOBAL PROGRAM HEAD, COMPLIANCE AUDIT AND MONITORING - Otsuka Pharmaceuticals
Location: Can be located in either Rockville, MD or Princeton, NJ

At Otsuka, we defy limitation, so that others can too.

We have an unwavering belief in doing more. In transcending expectations. In going above and beyond-under any circumstances-for patients, families, providers, and for each other. It's this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day.

We believe that the bigger the challenge, the bigger the opportunity. We are doing everything in our power to live up to our mission of creating new products for better health worldwide in two important therapeutic categories: neuroscience and nephrology.

Our culture is rooted in our Japanese heritage and almost 100-year history. Otsuka-people live by the core principles of Jissho - the achievement, completion, and discovery of truth; and Sozosei - pursuing that which only Otsuka is capable of delivering. We approach our business and overcome challenges through perseverance, unconventional thinking and humility.

Learn more about Otsuka Pharmaceutical Company on its global website at http://www.otsuka.co.jp/en. Learn more about Otsuka in the U.S. at www.otsuka-us.com.

Global Program Head, Compliance Audit and Monitoring

This role supports the Global CECO and wider Global Ethics & Compliance team in the creation, coordination and management of a global compliance audit and monitoring plan across all Otsuka pharmaceutical businesses.

**Please note that this position can be located in either Rockville, MD or Princeton, NJ


Responsibilities include but not limited to the following:
The major responsibility of this position is high-level oversight of engagement execution including ensuring standardization, reporting global compliance audit and monitoring results, as well as maintaining and further strengthening relationships with global business stakeholders

  • Develop and implement new global practices and guidelines for compliance auditing and monitoring ensuring plans are risk-based and regionally appropriate for both the Global Ethics and Compliance and Global Privacy teams
  • Create a risk-based compliance audit and monitoring plan for internal organizations, including CSIRT, and vendors/ third parties/ CROs
  • Engage with executive level personnel on global compliance audit and monitoring planning and priorities
  • Act as global liaison between US, EU and Japan/OIAA compliance audit and monitoring leads and key stakeholders (e.g., Sales & Marketing, and Global Quality, Regulatory and Safety (GQRST) personnel etc.)
  • Coordinate global execution of compliance audit/monitoring plan through frequent interaction with regional compliance colleagues
  • Track status of audits and monitoring activities globally, including synthesizing key findings/issues
  • Present key global issues to global Ethics & Compliance leadership and gain consensus on path forward
  • Work closely with other key global functions (e.g., Human Resources, Finance, Legal) to coordinate consistent approach to follow-up activities globally

Qualifications:

  • BA or BS Degree required, relevant advanced degree preferred
  • Proficiency in multiple languages desirable
  • Certified Internal Auditor, Certified Public Accountant, or Certified Fraud Examiner designation preferred
  • Minimum 10 years of legal, compliance or commercial experience is required.
  • Minimum 5 years in the healthcare or pharmaceutical industry is preferred.
  • Proven track-record in planning and executing corporate compliance audits and monitoring activities for a multi-national company
  • History of successfully working across geographies and cultures and with a variety of personalities and working styles
  • Thorough knowledge of US, EU and international pharmaceutical laws (including fraud and abuse, anti-kickback/anti-bribery, FCPA, FCA) is required
  • Ability to work with ambiguity, and respond to a rapidly changing, highly innovative environment
  • History of success in working as an individual contributor while showing ability to organize projects and work responsibilities, prioritize, and meet deadlines
  • Strong verbal and written communications skills - candidate must be skilled and comfortable with presentations to executive management
  • Up to 20% domestic and international travel is required based upon business needs.

 Apply here
Posted 1/18/2020

GLOBAL PROGRAM DIRECTOR, RISK ASSESSMENT AND MANAGEMENT - Otsuka Pharmaceuticals
Location: Can be located in either US, Japan or Europe

At Otsuka, we defy limitation, so that others can too.

We have an unwavering belief in doing more. In transcending expectations. In going above and beyond-under any circumstances-for patients, families, providers, and for each other. It's this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day.

We believe that the bigger the challenge, the bigger the opportunity. We are doing everything in our power to live up to our mission of creating new products for better health worldwide in two important therapeutic categories: neuroscience and nephrology.

Our culture is rooted in our Japanese heritage and almost 100-year history. Otsuka-people live by the core principles of Jissho - the achievement, completion, and discovery of truth; and Sozosei - pursuing that which only Otsuka is capable of delivering. We approach our business and overcome challenges through perseverance, unconventional thinking and humility.

Learn more about Otsuka Pharmaceutical Company on its global website at http://www.otsuka.co.jp/en. Learn more about Otsuka in the U.S. at www.otsuka-us.com.

Global Program Director, Risk Assessment and Management

This role supports the Global CECO and wider Global Ethics & Compliance team and will be responsible for coordinating our global risk assessment function and managing the enterprise wide risk register, which is a key part of Otsuka's global compliance program.

**Please note that this position can be located in either US, Japan or Europe


Responsibilities include but not limited to the following:

  • Developing and implementing new global program for compliance risk assessment and management (including development of best practices and guidelines)
  • Supporting and coordinating compliance risk assessment efforts globally, leveraging in-country compliance professionals for information
  • Managing relevant third parties involved in conducting compliance risk assessments in specific regions
  • Providing expertise and assistance to regional compliance leads to operationalize global compliance risk assessment operations
  • Working with IT to establish appropriate technology platforms to support global compliance risk assessment efforts
  • Understanding in-country risk assessment efforts already in place within affiliates, and providing a connection, both as a liaison and from a technology perspective, for these local solutions to be rolled up into a global risk register
  • Assisting with the roll-out of global compliance risk assessment approaches and solutions to all regions and affiliates
  • Capturing and reporting metrics in a meaningful and engaging manner that helps the Global CECO and other senior leaders understand Otsuka's global compliance risk profile

Qualifications:

  • BA or BS Degree required, relevant advanced degree preferred
  • Proficiency in multiple languages desirable
  • Minimum 8 years working in a Compliance or Legal organization, and preferably in pharmaceutical/biotech industry is required.
  • Strong understanding of US, EU and international pharmaceutical laws (including fraud and abuse, anti-kickback/anti-bribery, FCPA, FCA) and implications for business strategy is required.
  • Strong verbal and written communications skills - candidate must be skilled and comfortable with presentations to executive management
  • Ability to work with a variety of personalities and working styles, including across geographies and cultures
  • Excellent analytical and problem-solving skills with keen attention to detail
  • Strong organizational and project management skills
  • Track record of successfully working as an individual contributor, independently setting direction and demonstrating initiative under conditions of ambiguity
  • Proficiency in Excel required (e.g., formulas, pivot charts, pivot tables, formatting, etc.)
  • Up to 20% domestic and international travel is required based upon business needs.

 Apply here
Posted 1/18/2020

COMPLIANCE OPERATIONS MANAGER - Incyte
Location: Wilmington, DE US

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

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

Job Summary (Primary function)
The Compliance Operations Manager is responsible for managing various systems and operational aspects of Incyte's global Compliance program with an emphasis on Compliance training, communications, and policies. The position will be responsible for developing, documenting, and tracking training and education of employees and external third parties, planning and developing internal communication activities and maintaining and managing Incyte's corporate policies. Additional responsibilities include managing other Compliance systems used to track and document Incyte's Compliance activities and preparing various reports related to the Compliance department activities.


Essential Functions of the Job (Key responsibilities)

  • Assist with the development of live and module training and communications for Incyte's Compliance program.
  • Manage Incyte's corporate policy inventory and employee training matrix, including facilitating the appropriate review and approval process for new or revised policies. Assist with regularly assessing key policies and procedures to mitigate identified risks and to meet government, industry, and company compliance requirements.
  • Manage the learning and document management systems used for trainings and policies, including training launches, completion tracking, and appropriate document retention.
  • Manage other Compliance systems including the policy exception process, Compliance mailbox, conflict of interest log, and other systems that may be developed.
  • Routinely work with global and regional functions to coordinate and execute policy, training, and communication efforts. Work with translation vendors to translate materials as needed.
  • Maintain and update internal and external facing web platforms that support the Compliance function.
  • Assist with the preparation of readouts, slide decks and dashboards related to compliance operations and progress.
  • Contribute positively to a strong culture of compliance and ethics.

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

  • Bachelor's degree preferred.
  • Minimum five years relevant experience with three + years of pharmaceutical company compliance experience preferred.
  • Working knowledge of laws, regulations, and industry guidance that affect the pharmaceutical industry including federal and state government price report laws, fraud and abuse and anti-kickback statues, OIG and PhRMA guidelines, state marketing compliance laws, the Foreign Corrupt Practices Act, the UK Bribery Act, and other anti-bribery laws preferred.
  • Ability to work in a fast-paced environment and to handle multiple complex and confidential tasks. Strong detail orientation and focus on quality work product.
  • Strong written, oral communication, interpersonal, and organization skills.
  • Self-motivated, solution-oriented and adaptable.
  • High level of professionalism, integrity and ability to maintain confidences while working with sensitive, confidential information.
  • Experience working with affiliates outside of the US a plus.

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

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

 Apply here
Posted 1/16/2020

SR. MANAGER GLOBAL COMPLIANCE - Incyte
Location: Wilmington, DE US

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

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

Job Summary (Primary function)
This position will include management and support of Incyte's Global Corporate Compliance Program, with significant interaction with Incyte's US business, Global and Regional functions, Country Management and other departments. This position will work to continuously enhance Incyte's Compliance program through application of best practices in the life sciences Compliance space.


Essential Functions of the Job (Key responsibilities)

  • Support the development, enhancement and implementation of Incyte's Compliance program elements across regions and markets with a view toward global harmonization.
    • In collaboration with EU, US and other Regional and Country Compliance leads, contribute to development of global compliance annual plans and priorities based on risk assessments and other relevant inputs.
    • Draft, coordinate and help implement global, regional and/or local Compliance policies, SOPs and other Compliance tools and templates.
    • Support development and delivery of live and/or recorded compliance training.
    • Support global compliance efforts by participating in the design and development of compliance monitoring activities.
    • Conduct Compliance reviews of certain business activities, e.g. external funding requests.
    • Represent Compliance at key business meetings and industry events.
    • Provide ongoing support to general compliance projects and processes as necessary.
  • Support Incyte's global anti-bribery anti-corruption (ABAC) program including policy, training and process needs.
    • Manage and implement enhancements to Incyte's third party due diligence processes, including management of system, third party risk criteria, ordering and review of diligence, developing mitigation actions in collaboration with the business, and ongoing monitoring of higher risk third parties.
    • Work cross-functionally to support Incyte's efforts to continuously enhance third party man
  • Support development and implementation of new Compliance programs in new markets.
    • Assist in development and implementation of compliance plans for new affiliates and/or partners in new, global markets.
    • Provide guidance to new affiliates and/or partners, and integrate compliance controls into the scope of these businesses as applicable with a focus on global harmonization and "right sizing" the program.
  • Provide regular updates to Global, EU and US Compliance Leads, and provide input into quarterly Global & US Compliance Committee meetings and bi-annual Audit Committee meetings. Help prepare and deliver regular compliance program readouts, slide decks and dashboards.
  • Maintain a current working knowledge of various laws, regulations, and industry guidance that affect the corporate-wide compliance program, including federal and state government price reporting laws, state and federal privacy laws including GDPR, fraud and abuse and anti-kickback statutes, OIG guidelines, industry codes in relevant markets including PhRMA, EFPIA and JPMA, US state marketing compliance laws, FCPA, UK Bribery Act and other anti-bribery laws.
  • Contribute positively to a strong culture of compliance and ethics.

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

  • Bachelor's degree required.
  • Minimum of 7 years of compliance experience in the pharmaceutical and life sciences industry preferred.
  • Experience in the areas of global compliance best practices, including working in markets outside the United States.
  • Knowledge of and experience with laws, regulations, and industry guidance that affect the pharmaceutical industry.
  • Effective public speaking skills and an ability to communicate in both verbal and written form with multiple stakeholders within and outside the company.
  • Collaborative team player with ability to work effectively with cross functional teams and projects both within and outside of the Compliance function.
  • Strong problem solving, risk analysis, and project management skills.
  • Proficiency in Microsoft Office; experience in data analytics a plus.
  • Ability to effectively prioritize and work in a fast-paced environment and to handle multiple complex and confidential tasks.
  • Ability to travel domestically and internationally up to 25% of the year.

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

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

 Apply here
Posted 1/16/2020