The Pharmaceutical Compliance Forum

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EMPLOYMENT OPPORTUNITIES


 

SENIOR MANAGER - GOVERNMENT REPORTING - Novo Nordisk


Purpose
The position is responsible for managing daily operational activities related to the Ethics & Compliance Department's government reporting obligations (e.g. Transparency Reporting , Corporate Integrity Agreement (CIA), Risk Evaluation and Mitigation Strategy (REMS), etc.).

Relationships
This position reports to the Associate Director - Government Reporting, and regularly interacts with other compliance staff, information technology, and Novo Nordisk lines of business (e.g. Legal, Information Technology, Commercial Effectiveness, Clinical Operations, and Marketing Effectiveness). The position will also interact with external customers including Health Care Professionals (HCP), third party/external vendors, and external consultants. This position may interact with government officials and may manage employees in NNI's Global Servicing Center in Bangalore as requested.

Essential Functions:

  • Supports the Associate Director - Government Reporting in facilitating and raising awareness while fostering accountability for Ethics & Compliance program throughout the organization.
  • Maintains understanding of laws and regulations, enforcement actions and evolving practices relevant to pharmaceutical ethics & compliance and proposes updates to Ethics & Compliance program, as appropriate.
  • Manages the review and timely reporting of all government requirements while understanding local and global impact.
  • Informs management of ethics & compliance issues in a timely manner while encouraging the flow of information between colleagues and lines of business.
  • Actively works to identify, analyze, and mitigate potential business ethics and other risks to the organization.
  • Supports Associate Director with NN A/S collaborations regarding government reporting requirements and integration of systems/data.
  • Recommends enhancements to systems, processes and technologies for government reporting.
  • Manages creation and continued maintenance of government reporting protocols and assumption documents to support accurate filings.
  • Conducts training to employees and third party vendors to timely communicate new government reporting requirements.
  • Supports the government reporting budget (e.g. forecasting expenditures, reporting variances, and ensuring responsible spending) as requested.
  • Maintains understanding of applicable laws and regulations, enforcement actions and evolving practices/trends relevant to pharmaceutical compliance.
  • Responsible for ensuring that Compliance senior management is informed of compliance issues in a timely manner and encourages the flow of information between Compliance colleagues and lines of business.
  • Additional responsibilities with government reporting or departmental operational impact as assigned.

Physical Requirements

  • 0-10% overnight travel required

Education, Experience, Knowledge and Skills

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

  Apply here
Posted 7/19/2017


 

COMPLIANCE BUSINESS PARTNER, US IMMUNOLOGY - Shire
Title of Position Reporting To: Sr Business Partner, US Compliance
Work Location: Lexington, MA
Function: Corporate
Department: Global Compliance & Risk Management
Job Code: 10370
Job Level: Director


Primary Duties
The Compliance Business Partner reports to the Sr Business Partner, US Compliance, and provides primary direct support to certain Shire businesses operating in the US. The role also supports the US Compliance function in leading the development, implementation and management of the company's compliance program in the US. With particular focus on the Shire commercial business and medical affairs in the US, responsibilities include membership on the Business Leadership Teams, the implementation of policies, process review/monitoring and improvement, the development and delivery of targeted training, and counseling of the business for the purpose of fostering compliance with applicable laws and regulations in a manner consistent with best practices. Responsibilities will also include coordination with other Global Compliance and Risk Management functions in connection with policy development, training, monitoring, and investigations, and coordination with and support of other company Compliance personnel.

Responsibilities:

  • % of Time / Job Function and Description
  • 60   /   Counsel and provide leadership to Shire business units on compliance issues; work with other compliance personnel in US and with the Legal department and other support functions on various initiatives
  • 25   /   Develop targeted training for the assigned business and support the development of policies, process and procedures in key compliance risks areas
  • 15   /   Develop and execute risk assessments and reviews of compliance risk areas to determine need for improvement

Education and Experience Requirements:

  • Bachelor's degree from an accredited institution;
  • Post-graduate degree, law degree or healthcare compliance certifications a plus, but not required.
  • Minimum of 10-14 years of related work experience with at least 7 years' experience in the pharmaceutical industry or in the development and implementation of compliance programs.
  • Understanding of U.S. pharmaceutical/biotech and other regulations, sales, marketing and medical practices. Similar experience with international regulations and practices would be a plus.

Key Skills, Abilities, and Competencies
Strong interpersonal skills and ability to lead change through influence. Ability to interact with and counsel senior business leaders. Ability to accommodate and manage ambiguity. Ability to execute both strategically and tactically. Excellent written and oral communication skills. Effective presentation skills and ability and willingness to adapt to new cultures. A flexible, collaborative and team-oriented approach to problem solving, and an ability to work in a fast-paced, rapidly changing environment. Proven ability to exercise strong business judgment with a strong understanding of the fundamentals of the pharmaceutical/biotech industry.

Complexity and Problem Solving
Working as part of the senior level compliance team and in collaboration with other stakeholders (e.g. Legal Department), the candidate will have substantial authority to drive and implement programs throughout the US businesses, particularly in the US commercial business. The role will advise senior business leaders, including the business heads on key decisions. The role will represent the compliance function on cross functional efforts, while coordinating with Compliance leadership and Business Partner colleagues on key strategic decisions.

Internal and External Contacts
Internal: Global Compliance and Risk Management, business leadership, business field organization, Legal, Regulatory, Medical Affairs, HR, and Patient Services.
External: Coordinates with and manages external consultants and vendors as necessary

Other Job Requirements
Domestic travel will be required

  Apply here
Posted 7/19/2017


 

COMPLIANCE SPECIALIST - Shire
Title of Position Reporting To: Sr Business Partner, US Compliance
Work Location: Lexington, MA
Function: Corporate
Department: Global Compliance & Risk Management
Job Code: 10372
Job Level: Sr. Prof I


Primary Duties
The Compliance Specialist reports to the Sr Business Partner, US Compliance, and provides primary support to Shire businesses operating in the US. The role also supports the US Compliance function in leading the development, implementation and management of the company's compliance program in the US. Responsibilities include membership on the US Compliance Team, the implementation of policies, process review/monitoring and improvement, the development and delivery of targeted training, and fostering compliance with applicable laws and regulations in a manner consistent with best practices. Responsibilities will also include coordination with other Global Compliance and Risk Management functions in connection with policy development, training, monitoring, and investigations, and coordination with and support of other company Compliance personnel.

Responsibilities:

  • % of Time / Job Function and Description
  • 60   /   Implementation of policies, process review and improvement; collaborate with US compliance personnel, the Legal department and other support functions
  • 25   /   Develop targeted training for Shire businesses and support the development of policies, process and procedures in key compliance risks areas
  • 15   /   Support the US Compliance function with projects and initiatives that contribute to the development, implementation and management of the company's compliance program

Education and Experience Requirements:

  • Bachelor's degree from an accredited institution;
  • Minimum of 5 years of related work experience with particular focus in the pharmaceutical industry or implementation of compliance programs
  • Understanding of U.S. pharmaceutical/biotech and other regulations, sales, marketing and medical practices

Key Skills, Abilities, and Competencies
Strong interpersonal skills and ability to lead change through influence. Ability to interact with and counsel business leads. Ability to accommodate and manage ambiguity. Ability to execute tactically. Excellent written and oral communication skills. Effective presentation skills and ability and willingness to adapt to new cultures. A flexible, collaborative and team-oriented approach to problem solving, and an ability to work in a fast-paced, rapidly changing environment. Proven ability to exercise strong business judgment with a strong understanding of the fundamentals of the pharmaceutical/biotech industry.

Complexity and Problem Solving
Working as part of the US compliance team and in collaboration with other stakeholders (e.g. Legal Department), the candidate will contribute to the implementation of programs throughout the US businesses, particularly in the US commercial businesses. The role will advise business leads on policies and procedures, and demonstrate good judgment in identifying solutions. The role will represent the compliance function on cross functional efforts, while coordinating with Compliance leadership and Business Partner colleagues on key decisions.

Internal and External Contacts
Internal: Global Compliance and Risk Management, business leads, business field organizations, Legal, Regulatory, Medical Affairs, HR, and Patient Services.
External: Coordinates with and manages external consultants and vendors as necessary

Other Job Requirements
Domestic travel will be required

  Apply here
Posted 7/19/2017


 

SENIOR HEALTHCARE COMPLIANCE AUDITOR (GG10) - Allergan Pharmaceutical

Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceuticals and biologic products for patients around the world.

Allergan markets a portfolio of best-in-class products that provide novel treatments for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology, anti-infective and cardiovascular therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.

Our success is powered by our world-class team's commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what it is right.

Join one of the world's fastest growing pharmaceutical companies!

At Allergan you will have the opportunity to thrive in a fast-paced, strategic environment where bold, innovative thinking isn't just welcomed, it's encouraged. Across all functions, we relish the opportunity to help our people fulfill their potential. Our rapid growth strategy means plenty of opportunities to step into the spotlight.

Position Description
The Senior Healthcare Compliance Internal Auditor position is created for experienced Healthcare Compliance auditors: auditors who have had experience in commercial compliance, operational and financial auditing in the multi-national pharmaceutical or medical device industry. The position is ideal for someone looking to transition into a role in the Internal Audit organization.

On each audit, the Senior Healthcare Compliance Internal Auditor should demonstrate strong communication, planning, administrative, technical, and audit investigative skills, as well as establishing and maintaining good relationships with location and team members. In addition, the Senior Healthcare Compliance Internal Auditor must be willing to lead and be led by peers from time to time on various audits and department projects. The Senior Healthcare Compliance Internal Auditor should have basic skills in project management and internal controls. The Senior Healthcare Compliance Internal Auditor will report to the Sr. Manager, Healthcare Compliance. The successful candidate must be willing to travel up to 40% of the time to domestic and international locations. The position is considered rotational and provides opportunities to move into other areas of Finance and/or the business.

Main Areas of Responsibilities

Audit Planning:

  • Assist in development of risk-based audit plan
  • Identify healthcare compliance, financial and operational risks and incorporate into audit scope and audit program
  • Consult with manager/director on scope and audit timetable
  • Initiate discussions with business unit regarding planning and scope issues
  • Update audit program as appropriate
  • Communicate scope, timing and audit program to team

Audit Fieldwork:

  • Conduct audits consistent with IIA and department policies; manage timely completion of audit including communication of status to manager
  • Identify and document healthcare compliance exposures, operational/process issues, internal control deficiencies and opportunities for improvement
  • If applicable, coordinate fieldwork with Finance and IT Auditors
  • Prepare agenda and presentation for the audit closing meeting
  • Document audit findings into audit report format as the audit progresses
  • Adapt audit program and procedures as observations/new information is uncovered in the field

Audit Wrap-Up:

  • Requires limited direction to complete standard work.
  • Excellent project management skills: can prioritize multiple tasks and goals to ensure timely, on target and within-budget accomplishment of such
  • Proven track record of effective decision-making: makes good business decisions and consistently exercises sound judgment. Applies sound judgment around escalation of issues.
  • Strong verbal and written business communication skills: highly adept at synthesizing and summarizing complex and/or voluminous content into clear, concise and actionable communications
  • Strong process-orientation: has proven effectiveness in identifying, developing and implementing scalable/sustainable process and other continuous improvements to achieve organizational efficiencies and increase effectiveness

Requirements:

  • A minimum of 3 years in Corporate Compliance, Compliance Auditing and Monitoring, or relevant life sciences experience with a Big 4 Accounting Services firm is required. Proven experience leading and building teams through an audit engagement
  • Understanding of pharmaceutical or medical device commercial operations and/or of laws/guidance applicable to the regulation of commercial and other practices in the pharmaceutical and medical device industry (PhRMA and AdvaMed Code, Foreign Corrupt Practices Act, etc.).
  • Experience auditing commercial compliance processes (e.g., engagement and interactions with healthcare professionals, samples and free product, promotional material review, medical affairs, payments to third parties, donations, grants, discounts and rebates, etc).
  • Experience planning and performing integrated audits.
  • Knowledge of general sales and marketing processes and controls (e.g., order-to-cash, procure-to-pay, travel and expense reimbursement, distributor, wholesaler and consignment due diligence, and sales incentive compensation,) is required.
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint); experience with Teammate is a plus
  • Strong analytical and communication skills
  • Working knowledge of data analysis tools is a plus (ACL, Tableau)
  • Comfortable working and learning independently and as part of a team
  • Understanding of Sarbanes Oxley implementation practices and issues
  • Understanding of audit methodology and use of various audit tools to facilitate the audit process
  • Ability to travel domestically and internationally up to 40% of the time

Professional certifications such as Certified Fraud Examiner (CFE), Healthcare Compliance Certification (HCC), Certified Public Accountant (CPA) and/or Certified Internal Auditor (CIA) are preferred.

Education:

  • Bachelor's Degree (life sciences, law, public policy, marketing, business, education, finance/accounting or related discipline preferred)

  Apply here
Posted 7/18/2017


 

SR. COMPLIANCE MANAGER, U.S. RECONSTRUCTION, ROBOTICS, & SPORTS MEDICINE - Smith and Nephew
Memphis, TN


About Us
Smith & Nephew is a diversified advanced medical technology business that supports healthcare professionals in more than 100 countries to improve the quality of life for their patients.

We have leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma:

  • Orthopedics Reconstruction - joint replacement systems for knees, hips and shoulders
  • Advanced Wound Management - wound care treatment and prevention products used to treat hard-to-heal wounds
  • Sports Medicine - minimally invasive surgery of the joint
  • Trauma & Extremities - products that help repair broken bones

We have over 15,000 employees around the world. Annual sales in 2016 were more than $4.6 billion. We are a constituent of the UK's FTSE100.

SUMMARY
The Senior Compliance Manager supports the U.S. Sales and Global Marketing businesses, namely Reconstruction, Robotics, and Sports Medicine, which reports into and operates under the direction of the U.S. Compliance Director, Recon, Robotics, & Sports Medicine. The Senior Compliance Manager provides support for all elements of the Global Compliance Program including business team guidance, communication of compliance written standards, key control testing for significant risks, third party management, conducting investigations, design, and implementation of corrective actions and needs assessment guidance and review.

ESSENTIAL FUNCTIONS:

  • Oversight: Supports the implementation of the Global Compliance Program in the specified Sales and Global Marketing businesses under the direction of the Compliance Director. The responsibilities include supporting Compliance Committee and Compliance Ambassador Meetings, activities and material development, reviewing requests for HCP Arrangements, implementing approval processes as needed and supporting efforts to enhance the required Compliance Culture.
  • Written Standards: Provides support on the drafting, implementation and communication of Compliance-related policies and procedures.
  • Program Management: Implements actions as specified in the U.S. Compliance Plan of Action and Global Scorecard / KPIs.
  • Risk Management: Supports the U.S. Compliance Director in conducting compliance risk assessments in the business and developing and supporting implementation of mitigation plans.
  • Training and Communications: Supports the Global Compliance Training Team's implementation of the annual training and education plans. Implements applicable U.S. training, including New Manager training and New Field Sales Team training. Develops communications on key compliance risks and initiatives, as requested. Supplements with additional training as requested, according to the particular needs of the business.
  • Monitoring and Auditing: Supports the Global Compliance Monitoring and Internal Audit teams in conducting monitoring and auditing as required. Implements monitoring in applicable businesses, including ride-a-longs with field personnel and spot checks.
  • Third Party Management: Supports Third Party Seller and Non-seller Third Party (NSTP) compliance management and initiatives, including conducting Third Party Risk Assessments and site visits and implementing the Third Party Seller Due Diligence process and GPP08 for NSTPs.
  • Investigations: Conducts and/or assists in investigations to the extent requested, including conducting reviews of documentation, conducting interviews and drafting reports. Ensures consistent and appropriate investigative processes are utilized.
  • Corrective Actions: Implements and tracks appropriate and consistent corrective actions for identified compliance issues and assessment activities. Conducts assessments to determine effectiveness of corrective actions.
  • Advice and Guidance: Provides day-to-day advice and guidance to relevant business teams on Compliance matters.
  • Needs Assessment Activities: Supports the annual Needs Assessment review and reviews activity-specific ("sub need") submissions by the business teams. Provides training and guidance on the Needs Assessment process, including development of tools as required.

REQUIREMENTS:

Travel: 10 - 25% of the time, primarily in the U.S.

Education: Bachelor Degree or equivalent required

Professional Experience:

  • Minimum of four years of experience related to implementing a compliance program with-in a business, or other complementary job experience (such as roles within Internal Audit, Finance or Legal functions).
  • Expertise in Marketing or other fields will be considered upon demonstration of skill sets needed to perform the job duties.
  • Experience in Healthcare industry - Device, Pharma, or Biotech is preferable.

Competencies:

  • Excellent communication and interpersonal skills. Strong ability to communicate complex topics in concise terms.
  • Ability to communicate concisely and persuasively in writing as well as the ability to draft clear and effective reports, policies etc.
  • Ability to work independently and as part of a team.
  • Self- motivated and result-driven.
  • Ability to work in a matrixed organization, across cultures and functions with all levels of the organization.
  • Instinct to detect risk areas and red flags.
  • Solution-minded; desire to solve problems.
  • Ability to prioritize according to risk and make quick decisions with appropriate independence.
  • Ability to deal with ambiguity and change.
  • Project management skills. Ability to follow through and complete tasks on time.
  • Fluent in English.

Smith and Nephew is an Equal Opportunity / Affirmative Action Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by applicable law.

  Apply here
Posted 7/17/2017


 

SR. COMPLIANCE SPECIALIST / COMPLIANCE MANAGER - Smith and Nephew
Fort Worth, TX


About Us
Smith & Nephew is a diversified advanced medical technology business that supports healthcare professionals in more than 100 countries to improve the quality of life for their patients.

We have leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma:

  • Orthopedics Reconstruction - joint replacement systems for knees, hips and shoulders
  • Advanced Wound Management - wound care treatment and prevention products used to treat hard-to-heal wounds
  • Sports Medicine - minimally invasive surgery of the joint
  • Trauma & Extremities - products that help repair broken bones

We have over 15,000 employees around the world. Annual sales in 2016 were more than $4.6 billion. We are a constituent of the UK's FTSE100.

SUMMARY
The Senior Compliance Specialist / Compliance Manager supports the US Compliance Director, Wound Management in implementing and maintaining the Company's Global Compliance Program within the U.S. Wound Management Commercial business, and as requested, the U.S. Advanced Surgical Devices Division.

This role is primarily focused on compliance monitoring, and auditing and investigations, and may also include activities to support the development and deployment of compliance training and other compliance presentations (such as Compliance Committee meetings), assessing business risks and controls, and design and implementation of corrective actions, as described below.

ESSENTIAL FUNCTIONS:

  • Conduct field monitoring, data reviews and audits of key compliance risk areas, in accordance with the US monitoring program. Draft reports and identify corrective actions, assisting with implementation as necessary.
  • Conduct investigations of alleged misconduct. Draft reports and identify corrective actions, assisting with implementation as necessary.
  • Assist in implementation of compliance related policies and procedures, including development and implementation of compliance guidance and training materials.
  • Provide advice and support to Sales, Marketing, Professional Education and other key business stakeholders related to healthcare industry compliance and Company policies, procedures and Code of Conduct.
  • Support the Aggregate Spend Team in completing relevant state transparency reports and other state-driven compliance requirements, primarily for the US AWM business.
  • Manage and execute the third-party vendor compliance due diligence process for sellers and non-sellers.
  • Support the annual Needs Assessment process.
  • Manage US employee compliance with training requirements (e.g. late training, new manager onboarding training, annual compliance training, etc.).
  • Conduct ad-hoc reviews and special projects at the direction of the US Compliance Director, Wound Management.

REQUIREMENTS:

Travel: Domestic up to 25%.

Education: Bachelor's degree from an accredited university.

Professional Experience:

  • 3 - 4 years of healthcare compliance experience or related experience in the healthcare industry (pharmaceutical and / or medical device).

Competencies:

  • Demonstrated high level of competence in practically applying current ethical statutes, healthcare industry laws, policies and codes, and corporate policies as they relate to sales and marketing practices and interactions with healthcare professionals.
  • Strong analytical skills and business acumen to make sound decisions and recommendations.
  • Demonstrated ability to explain and enforce rules, processes, and regulations.
  • High level of problem solving and ability to moderate agreement among conflicting positions.
  • Excellent professional technical writing, verbal communication skills and presentation skills.
  • High level of professional discretion and diplomacy; able to strictly maintain confidential information.
  • Good negotiation, facilitation and persuasion skills and experience.
  • Proficiency with MS Office applications (Word, Excel, PowerPoint, etc.).

Smith and Nephew is an Equal Opportunity / Affirmative Action Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by applicable law.

  Apply here
Posted 7/17/2017


 

PRINCIPAL CLINICAL QUALITY & COMPLIANCE MANAGER, GOVERNANCE, STANDARDS AND CONTINUOUS IMPROVEMENT, QUALITY & COMPLIANCE OFFICE - Genentech


Job ID: 3102173819

Description: The Principal Quality & Compliance Manager, Governance, Standards, and Continuous Improvement (GSCI), is a strategic leadership role within gRED Early Clinical Development's Quality and Compliance Office (QCO). This position serves as an important conduit to the broader organization to ensure a culture of compliance through well-thought out, actionable, aligned and achievable related processes and procedures. Given the nature of the group's work, incumbent will communicate and interface with a host of internal cross-functional partners, both within gRED and other Roche functions; identifying areas for improvement and ensuring compliance with current regulatory policy, legislation and guidance.

The Principal Quality & Compliance Manager will set the strategy for his/her respective team and actively contribute to the development and implementation of continuous improvement initiatives, and Policy/Standard Operating Process / Procedures tools, and templates deemed controlled in supporting regulatory requirements for application in drug development and clinical trial execution for functions impacted within the Genentech Early Clinical Development organization.

Responsibilities:

  • Understands the Genentech and Roche organization, particularly ECD and Product Development organizational dynamics. Builds and manages key relationships within ECD and various global functions (Product Development, pRED, US Medical Affairs, etc.) to better understand and address the compliance-related needs of the business in order to better drive the strategic direction for compliance activities within ECD and to execute global medical and healthcare compliance activities.
  • Partners with other departments including, but not limited to: Drug Safety, Product Development Quality, PD Clinical Operations, Healthcare Law, Corporate Group & Risk Advisory, and the Healthcare Compliance Office, etc. Connects with managers of equivalent level (or higher) and leverages those collaborations to support and collaborate with QCO and gRED Early Clinical Development.
  • Provides advice to the business with respect to the development of cross-functional SOPs, Policies or Work Instructions for ECD.
  • Participates on GVPC (a global cross-functional team) as the delegate to the Director, Head of Governance, Standards, and Continuous Improvement.
  • Provides team leadership (oversight, guidance and subject matter expertise) and responsible for the strategic direction of the team to meet organizational objectives.
  • Identifies, recruits, hires and manages a team of 2-3 direct reports.
  • Anticipates change, and manages resources to support the team for continued success and value.
  • Partners with other members of the QCO Leadership Team to optimize and continually improve department processes, maintain role definitions and standards, and develop role-based competency and training programs for staff.
  • Helps ensure consistent compliance with and communication of corporate and other governing policies, procedures, regulations, laws and other pertinent guidelines for core ECD activities.
  • Determines and drives the development of annual and longer-range team objectives, plans, programs, projects and budgets for related compliance efforts.
  • Builds prominence of ECD and the QCO at the global level through key programs and communications.
  • Collaborates with the Head of QCO's Clinical Quality Compliance Team on the implementation and maintenance of the Functional Quality Management System (QMS) and its related documents, in alliance with the Quality principles outlined in the Global Roche GCP/GVP Quality Manual and QCO Quality Plan.
  • Identifies and anticipates trends in quality issues and collaborates with QCO LT to insure risk-managed solutions are implemented in a timely fashion.
  • Provides expertise and consultative guidance on business initiatives involving systems, processes, procedures, regulations and tools intended for use in clinical trial conduct and/or regulated drug development activities.
  • Leads and/or facilitates the process of continuous process improvement and leads internal and global cross- functional initiatives by overseeing analysis of "to be" processes; forms, templates and related process documents to ensure alignment, accuracy, and adherence to relevant internal/country/local legal and regulatory requirements.
  • Challenges and influences the modification/removal of inefficient processes, and maintains highest levels of awareness, expertise in international GxP regulatory requirements, and project-specific procedures applicable to the clinical trial methodology.
  • Provides regular updates to senior management functions and participates in the resolution of quality issues by fostering effective interdepartmental and cross-functional relationships.
  • Leads or participates on quality and compliance initiatives, as assigned.
  • Performs any other tasks as requested by Management to support quality oversight activities.

Qualifications & Requirements:

  • Bachelors degree required (life science or other relevant healthcare discipline is preferred).
  • Minimum of 12 - 15 Years/10 - 13 Years with Masters experience in pharmaceutical drug development, preferably in regulatory compliance and/or quality responsibilities within a drug development organization.
  • Previous experience in building and leading teams; coaching and developing others.
  • Previous experience in developing Systems/SOPs for an R&D Organization, experience in implementation of new processes, proven success facilitating change within a complex organization.
  • Strong organizational and prioritization skills, including the ability to manage multiple projects of different levels of complexity, ranging from strategic to highly tactical in nature.
  • Must demonstrate knowledge of GCP/ICH and QA issues within a global pharmaceutical organization.
  • Advanced understanding of numerous clinical development functional areas. Must be able to work independently majority of the time, ability to prioritize, identify conflicts and meet deadlines.
  • Strong project management skills including team leadership, consultative facilitation, risk analysis, and project planning; strong interpersonal skills.
  • Proven ability to influence people at different levels in a matrix organization and assist integration across locations and functions.
  • Strong aptitude to apply advanced theoretical knowledge and contributes to the development of new principles and concepts to independently address unusually complex problems.
  • Exercises sound and independent judgment in methods, techniques and evaluation criteria for obtaining results.
  • Strong computer literacy in MS Word, Excel, Project, Visio and PowerPoint.
  • Highly self-motivated, well organized, and able to develop alternative solutions to issues.
  • Excellent communication and presentation skills
    • Listening, interpreting and summarizing information
    • Clear and concise verbal communication
    • Professional and concise written communications -exceptional attention to detail required

  Apply here

The Job ID is 3102173819
Posted 7/1/2017


 

ETHICS & COMPLIANCE MANAGER - Canada & USA (Cambridge) - Ipsen


Position:
Department: Global Ethics and Compliance
Location: Toronto, Ontario, Canada
Supervisor: Edward Leskauskas

Purpose of the Position:

  • Execute and maintain Ipsen Biopharmaceuticals Canada & Ipsen Bioscience - Cambridge, MA, USA (Cambridge) Ethics & Compliance program on the basis of the Global Ethics & Compliance Program.
    • NOTE:
      • Ipsen Biopharamceuticals Canada is a commercial operation
      • Ipsen Bioscience (Cambridge) is a Research and Development operation
      • Contribute to the Global Ethics & Compliance Program

Main responsibilities and tasks:

  • Works as part of the Global Ethics & Compliance Department on compliance matters but not limited to local operations supporting Ipsen Canada & Ipsen Bioscience - Cambridge, MA, USA and be active member of the Global Ethics and Compliance team.
  • Contributes to the Global Ethics & Compliance Projects.
  • Works closely with, and frequently consults with, other members of the IPSEN Legal, Regulatory, Medical and Finance Team on Country or geographical cluster compliance related matters.
  • Contributes to Ethics & Compliance Governance of Ipsen Canada & Ipsen Bioscience - Cambridge, MA, USA through membership and attendance to country Management Committees and coordination/chairing of the Compliance Committees.
  • Co-ordinates the Ethics & Compliance Program execution for Ipsen Canada & Ipsen Bioscience - Cambridge, MA, USA on the basis of the Global Ethics & Compliance Program prepared and issued at Global level, and contributes to its continuous improvement.
  • Act as the Compliance responsible person for driving the Ipsen Canada & Ipsen Bioscience - Cambridge, MA, USA, Ethics & Compliance Program, including policies, education and monitoring plans, based on the Global Program, including the following:
    • Supports local operations with queries and compliance-related advice
    • Identifies needs for procedural documents and support implementation in Canada & Cambridge.
    • Identifies and provides training and guidance needs for Canada & Cambridge, particularly based on local needs and requirements and contributes to the development of annual Canadian & Cambridge education plan and implement it.
    • Supports process owners and Global Ethics & Compliance Education Manager in ensuring training is performed, recorded, tracked and reported.
    • Participates in the development with the Global Ethics & Compliance Team of the Global monitoring plan and drives execution of specific Canadian & Cambridge monitoring plan.
  • Provides input on local code rules, processes, and language requirements and more particularly provides all necessary support for the program's effective enforcement.
  • Informs immediately the Vice President, Ethics & Compliance North America on any potential compliance related issue.
  • Participates in or leads Canadian/Cambridge specific investigations of local informal or formal complaints generated by an internal or external source
  • Represents Ipsen Canada & Ipsen Bioscience - Cambridge, MA, USA on country specific industry committees/associations (e.g. PhRMA, BioTech Canada, IMC) and informs the local operations and Global Ethics & Compliance organization on country specific requirements and local pharmaceutical associations Code of Conducts

Experience / Qualifications:

  • 3-5 years' experience in a pharmaceutical company compliance department or within a function in relation with the Pharma Regulatory environment.
  • Ideally, previous experience in dealing with multi-country regulations.
  • Ideally first experience in people management.
  • Previous experience in a multinational and multicultural business environment is required.
  • Ideally, you will have in-depth exposure to legal and regulatory issues in the Pharmaceuticals sector from a previous experience including policies and procedures issuance, compliance trainings.
  • Demonstrated and proven knowledge of the IMC code, PhRMA code, understanding of the IFPMA code, the EFPIA Codes, as well as local codes and regulations.

Required Competencies:

  • Reporting directly to the Vice President, Ethics & Compliance North America, you will have the leadership and communication skills to work with people at all levels within the organization.
  • Proven leadership and communication skills, particularly in communicating with highest levels of senior management.
  • Expertise in providing sound, ethical advice to management on a board range of business issues.
  • Strong international background.
  • Ability to address multiple and complex ethical and compliance issues.
  • Ability to mediate and reconcile different views and to demonstrate leadership.
  • Ability to summarize, transform and communicate complex messages into pragmatic language and educational tools, for ensuring easy access to rules.
  • Strong communication and listening skills, in particular the ability to train a large audience, respond to questions, present complex matters to management.
  • Outstanding project management, organizational and management skills.
  • Strong team-playing skills and the ability to participate in large working groups.
  • Ability to exercise good judgment in challenging or adverse situations, while remaining solution oriented.
  • Strong knowledge of web-based technology, Microsoft Pack Office and various software systems (e.g. SAP).
  • Good knowledge of English is required. Knowledge of French is a plus.
  • Travel ratio is approximately 25% time. Systematic working time in each country is required.
  • Position will be based in Toronto, Ontario, Canada

Mission Statement:
To maintain an effective compliance and ethics program that ensures a culture of integrity enabling Ipsen to conduct its global business with the highest ethical standards, in full compliance with all applicable laws and regulations and Ipsen's Code of Conduct. To review regularly and improve our compliance and ethics program to ensure it remains current with respect to significant risks, developments and trends.

  Apply here
Posted 7/1/2017


 

DIRECTOR, COMMERCIAL HEALTHCARE COMPLIANCE - Astellas


Astellas is the bright spot in the pharmaceutical industry -- not just because of what we do, but in the way we do it. If you are looking for a company where you can change a life, make a dream come true, and light the way for a better tomorrow, Astellas is the place where you can shine.

We offer a different kind of work culture. A high standard of ethics is mandatory. Quality is our pledge. Diversity is valued. Individual initiative is rewarded. Astellas offers an environment where our employees can make a real difference. Come, shine with us!

Astellas is announcing a Director Commercial Healthcare Compliance opportunity in Northbrook, IL.

Purpose & Scope:
The Director, Commercial Healthcare Compliance develops and implements strategy and is accountable and responsible for leading the healthcare compliance program for commercial functions in the US (including Sales, Marketing, Health Systems, product-specific therapeutic areas and client groups, and commercial operations) and providing global matrix support for the global Marketing Strategies function in close collaboration with the Executive Director, Healthcare Compliance, Monitoring & Investigations, Americas. This position also develops and implements strategy and leads the Conflict of Interest program for the Americas in close collaboration with local and regional Ethics & Compliance leads. The Director is a strong leader and promotes a highly ethical, compliant and accountable culture that encourages and enables employees to raise potential or actual compliance concerns.

Essential Job Responsibilities:
Key accountabilities and responsibilities include the following in close collaboration with and at the direction of the Executive Director, Healthcare Compliance, Monitoring & Investigations, Americas:

  • Effectively implementing the global and US-specific compliance standards through strategic planning, oversight and effective communication, training and monitoring of policies, controls and initiatives across commercial functions in the US and as part of matrix support for global Marketing Strategies.
  • Develops and leads strategies to ensure adherence to Company policies relating to commercial healthcare compliance in the US. Responsible for developing a team of commercial Healthcare Compliance experts. Develops strategies and leads implementation of strategies to continually enhance and maintain a highly ethical, compliant and accountable culture.
  • Leads and develops strategies for Ethics & Compliance program in alignment with strategic business models and healthcare landscape. Provides sophisticated ethics and compliance guidance for key strategic business teams/initiatives. Regularly meets with senior business leaders and participates in, influences and provides advice for strategic business models, projects and initiatives. Develops strategy for and leads ethics and compliance support for product launch initiatives.
  • Develops and implements strategies for and leads collaboration with the business to embed a culture of compliance, accountability and consequence for non-compliance. Develops strategies for, leads and is accountable for continually enhancing business ownership of controls and systems designed to ensure adherence with the Company's ethical and compliance standards.
  • Develops strategy for, oversees and leads support at key business meetings, including national leadership forums, national sales forums, and product launch meeting. Oversees timely, consistent and effective compliance guidance, direction and support to commercial field teams.
  • Develops strategy for, oversees and leads healthcare compliance projects/initiatives in alignment with a global ethics and compliance focus and interacts closely with local, regional and global Ethics & Compliance teams to ensure adherence to laws, regulations, industry codes, policies, processes and to promote best practices.
  • Develops strategy for and leads the continuous assessment and enhancement of the healthcare compliance program relating to client groups in close collaboration with business stakeholders, and makes recommendations to local, regional and global Ethics & Compliance leaders as appropriate for opportunities for enhancement.
  • Coordinates and collaborates closely with the non-commercial Healthcare Compliance team in order to develop strategies for effective integrated healthcare compliance program consistent with global strategies/policies/processes; ensures that the Ethics & Compliance support is well coordinated, responsive to the business and in adherence with the Company's ethical and compliance standards.
  • Leads and develops strategies for Ethics & Compliance support in the development and execution of promotional strategies and activities, including the review and approval of Astellas-sponsored activities, annual brand plans and speaker bureaus/programs. Attends Material Approval Process meetings as appropriate.
  • Develops strategy for and oversees the Conflict of Interest program for the Americas in close collaboration with local and regional Ethics & Compliance leads.
  • Continually evaluates and identifies needs relating to compliance training and education for client groups. Provides strategic input into the design, development, implementation and delivery of innovative compliance training materials, communications, presentations, workshops and systems, as well as developing content and delivering and leading presentations and workshops with the business. Facilitates business involvement and input from the client groups in compliance training and communication development.
  • Develops strategy for and leads collaboration with business partners on commercial healthcare compliance matters. Supports due diligence and integration of merged, acquired or collaboration partner entities.
  • Partners with local and regional monitoring teams to share insights, observations and knowledge of ongoing and developing business strategies/initiatives/activities in order to ensure learnings are incorporated into the monitoring activities at the local, regional and global level and to ensure that any corrective actions and/or enhancements are tailored to ensure highly ethical and compliant business conduct. Also participates in development and execution of live and transactional monitoring program.
  • Coordinate and collaborate with the local, regional and global operations teams with respect to the auditing, monitoring, training and communications needs of the business, including proactively identifying such needs and opportunities for enhancement, and developing and implementing appropriate training and education programs.
  • Collaborates with cross-functional teams locally, regionally and globally to influence the commercial Healthcare Compliance strategy to ensure alignment with US and support development and expertise within Ethics & Compliance.
  • Researches, benchmarks, stay current and maintain sophisticated knowledge of applicable legal and regulatory developments, industry standards, Company business strategies and the changing healthcare landscape to determine emerging compliance trends and incorporate such developments, standards and trends into education for the Ethics & Compliance team as well as the compliance strategies and advice provided to the business.
  • Other Ethics & Compliance initiatives deemed necessary to further enhance Astellas' commitment to high ethical standards and compliance with the law.

Quantitative Dimensions:
Responsible for operating within the regional compliance budget, and any applicable project specific budgets.

Organizational Context:

  • Directly reports to the Executive Director, Healthcare Compliance, Monitoring & Investigations, Americas
  • Works closely and collaborates with Ethics & Compliance regional leadership and operations.
  • Collaborates with approved team members via matrix global organization for the Marketing Strategies function and manages at least two direct reports, including at least 1 Associate Director
  • Leads and ensures the effective implementation of the commercial Healthcare Compliance program in the US and closely coordinates with Ethics & Compliance counterparts across the globe
  • Works closely and collaborates with leadership in the US

Qualifications:
    Required

  • Minimum of 10 years experience in Compliance or related functions (e.g., regulatory, legal, audit, or risk).
  • Advanced degree (Juris doctor; Masters; Ph.D) or advanced compliance certifications (CCEP or equivalent).
  • Expertise in compliance with law, regulations and industry codes relevant to the pharmaceutical industry. Sophisticated knowledge of the best practices relating to compliance in highly regulated industries.
  • Proven ability to lead high-level, broad-based objectives in the context of annual compliance objectives.
  • Strong analytical, organizational, problem solving, and follow-up skills. Ability to interpret rules and guidelines, and ability to conceptualize policies, procedures and controls.
  • Ability to self-start and self-direct work in a fast-paced environment.
  • Excellent project management skills. Ability to prioritize and work simultaneously on multiple projects, strong attention to detail, and ability to organize and analyze complex information and data.
  • Demonstrated experience leading compliance operations projects and activities in a matrixed, global organization.
  • Excellent written and verbal executive-level communication skills.
  • Adaptability necessary to work effectively in a sometimes ambiguous, changing, and matrix global environment.
  • Exceptional ethics and commitment to integrity, interpersonal skills, professionalism, and collegiality.
  • Manage multiple projects/processes efficiently at the same time.
  • Ability to demonstrate sound and independent judgment, prudence and maturity in complex and sensitive cases.
  • Client orientation with a constructive approach to resolution of issues. A style which builds alliances within the organization, locally/globally, and/or corporate collaborators.

    Preferred

  • Experience working globally

  Apply here
Posted 6/24/2017


 

ASSOCIATE MANAGER, COMPLIANCE - Avanir Pharmaceuticals, Inc.
Aliso Viejo, CA


About Us
Avanir Pharmaceuticals, Inc. is a biopharmaceutical company focused on bringing innovative medicines to patients with central nervous system disorders of high unmet medical need. As part of our commitment, we have extensively invested in our pipeline and are dedicated to advancing medicines that can substantially improve the lives of patients and their loved ones. For more information about Avanir, please visit http://www.avanir.com.

Avanir is a subsidiary of Otsuka America, Inc. (OAI), a holding company established in the U.S. in 1989. OAI is wholly owned by Otsuka Pharmaceutical Co., Ltd. The Otsuka Group employs approximately 42,000 people globally, and its products are available in more than 80 countries worldwide. Otsuka welcomes you to visit its global website at https://www.otsuka.co.jp/en.

The Associate Manager, Compliance is a member of the Transparency Reporting team supporting Avanir's aggregate spend initiatives to comply with Federal (i.e. Open Payments), State, and Global transparency reporting obligations. As a member of a collaborative team, this position also will contribute to the development and implementation of other components of the compliance program.

  • Works with business owners across functions to ensure they understand their reporting obligations and that reports are filed with federal and state authorities in line with applicable federal and state healthcare provider transparency laws and requirements
  • Support operations to ensure timely review, remediation, and accurate submission of all transparency reporting.
  • Development and maintenance of operational processes for periodic data review and issue resolution.
  • Analyze data from multiple systems and determine reportable transactions for Federal and State reporting.
  • Perform audit and data review functions to ensure accurate and complete capture of all reportable transactions.
  • Interfaces with 3rd party vendors to ensure completeness, accuracy, and timeliness of data.
  • Works with Aggregate Spend Manager and other cross functional teams to establish and gain consensus on project goals, objectives, schedule, and deliverables.
  • Updates stakeholders on projects' status, risks, and resource requirements.
  • Supports resolution of transparency reporting-related discrepancies and providing clarifications related to associated transparency reporting policies.
  • Supports the development and revision of policy, procedures and work instructions for Aggregate Spend processes.
  • Stays current with CMS and other information sources for latest information regarding aggregate spend at both the federal and state levels.
  • Responsible for helping define new compliance business processes for all new/changing federal and state transparency reporting as laws are enacted or passed.

QUALIFICATIONS:

  • BA/BS degree required; Master's preferred
  • A minimum of 5 years of compliance, finance, accounting, legal or other business function experience required; preferably pharmaceutical/device/healthcare.
  • Strong attention to details
  • Excellent verbal and written communication skills
  • Strong interpersonal and presentation skills
  • Ability to successfully work with multiple stakeholders and support cross-functional coordination
  • Strong organizational, analytical, project management and team building skills
  • Ability to prioritize, schedule and manage multiple projects
  • Ability to manage ambiguity - Adaptable to change in an evolving business environment
  • Working knowledge of MS Word, Visio, Power Point, Excel, Access, and Outlook
  • Working knowledge of analytics tools (e.g., Tableau)
  • Good understanding Pharmaceutical and Medical Device commercial operations and the laws, regulations and guidance applicable to the industry (e.g., Food, Drug and Cosmetic Act and of the roles and authority of government agencies and industry partners, PhRMA, FDA, OIG, PDMA, Affordable Care Act, PDMA, ACCME, etc.)
  • Project Management and/or audit experience a strong plus
  • Knowledge of U.S. and global aggregate spend reporting requirements as it relates to the pharmaceutical or medical device industry.

  Apply here
Posted 6/9/2017


 

ASSOCIATE DIRECTOR, COMPLIANCE - Avanir Pharmaceuticals, Inc.
Aliso Viejo, CA


About Us
Avanir Pharmaceuticals, Inc. is a biopharmaceutical company focused on bringing innovative medicines to patients with central nervous system disorders of high unmet medical need. As part of our commitment, we have extensively invested in our pipeline and are dedicated to advancing medicines that can substantially improve the lives of patients and their loved ones. For more information about Avanir, please visit http://www.avanir.com.

Avanir is a subsidiary of Otsuka America, Inc. (OAI), a holding company established in the U.S. in 1989. OAI is wholly owned by Otsuka Pharmaceutical Co., Ltd. The Otsuka Group employs approximately 42,000 people globally, and its products are available in more than 80 countries worldwide. Otsuka welcomes you to visit its global website at https://www.otsuka.co.jp/en.

The Associate Director, Compliance, assists the Chief Compliance Officer (CCO) in developing, implementing and maintaining an effective Corporate Compliance Program that:

  • Supports and promotes a company-wide culture of ethics and compliance;
  • Meets or exceeds current regulatory standards for effective compliance programs, including OIG Guidelines, the U.S. Federal Sentencing Guidelines, and DOJ guidance.
  • Ensures the company's compliance with all applicable federal and state health care laws and regulations, and industry codes of conduct.
  • This position requires the flexibility and knowledge to support all elements of Avanir's Compliance Program.

Manages elements of the Avanir Compliance Program, potentially including but not limited to:

  • Developing and delivering compliance training at company and departmental meetings (including training directed to the company's compliance reporting and investigations program).
  • Assisting the CCO in preparing and presenting reports and dashboards to the Compliance Committee and the Board of Directors that are directed to the compliance reporting and investigation program.
  • Preparing and presenting reports and dashboards to management regarding our compliance reporting and investigations program.
  • Developing, revising, updating and maintaining compliance policies, procedures and instructions, and collaborates with other departments of the company in addressing their policies, etc. relating to or impacting the company's healthcare compliance program.
  • Leading or supporting the implementation of systems (both IT systems and processes) that enable efficient, consistent and compliant execution of business activities
  • Possesses and maintains an up-to-date knowledge and understanding of federal and state laws and regulations, industry codes of conduct and developments, and best practices applicable to the company's policies, practices or operations, including but not limited to the 2003 OIG Compliance Program Guidance for Pharmaceutical Manufacturers, PhRMA Code on Interactions with Healthcare Providers, PDMA, AMA, and industry guidance documents, regulations regarding the promotion of marketed products, clinical trial regulations, and the False Claims Act and anti-kickback statutes.
  • Collaborates within the Compliance team and manages projects to ensure inter and intra department coordination
  • Leading or supporting ongoing implementation of organizational needs assessment.
  • Leading or supporting ongoing implementation of external reporting obligations
  • Other responsibilities and duties as may be assigned.

QUALIFICATIONS:

  • Bachelors degree required. Advanced degree, e.g. J.D., Masters, PhD, etc., a plus.
  • Minimum of five+ years experience in the pharmaceutical or device industry.
  • Strong ethics and integrity.
  • Ability to work independently with no routine supervision.
  • Demonstrated ability to exercise independent judgment with knowledge of the pharmaceutical industry.
  • Strong interpersonal skills and collaborative ability.
  • Strong analytical skills and demonstrated ability to successfully perform multiple projects in a timely and effective manner.
  • The ability to work under pressure and meet deadlines.
  • Excellent planning, project management and research skills.
  • Ability to analyze data, develop and maintain databases, and generate formal written reports.
  • The ability to communicate, orally and in writing, effectively and persuasively.
  • Track record for successfully working cross-functionally on a wide range of pharmaceutical compliance activities.
  • Experience in creating and implementing training programs including strong speaking skills.
  • Ability to identify problems, explore options and recommend solutions through strong critical thinking, problem solving and decision making skills.
  • Effective at managing, synthesizing and communicating complex information.
  • Demonstrated experience in handling confidential and sensitive situations or information with ability to exercise a high degree of judgment and discretion while maintaining strict confidentiality as required.
  • The ability to travel from time to time.

  Apply here
Posted 6/9/2017


 

SR. MANAGER CORPORATE FUNDING COMPLIANCE - Celgene Corporation
LOCATION: SUMMIT, NEW JERSEY
SUPERVISOR: Senior Director, US HCC
DEPARTMENT: Global Compliance


Prerequisites:

  • BS/BA or equivalent with minimum of 5 years of pharma/biotech experience.
  • Understanding of regulations and knowledge of pharmaceutical policies & procedures in support of corporate funding.

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

  • Ensure compliance and adherence to Celgene policies and procedures related to corporate funding activities (donations, sponsorships and corporate memberships).
  • Coordinates with Corporate Advocacy team in the oversight, triage, routing, review and support of corporate funding requests, including communicating outcomes as appropriate.
  • Collaborate and engage with Celgene stakeholders on the strategic plan for corporate funding to align with Celgene's therapeutic, community and business interests and in compliance with all applicable local laws and regulations, and Celgene policies and procedures.
  • Coordinate and facilitate compliance review of corporate funding requests supporting the decision-making process within Celgene's areas of interest. As needed, shepherds the review process through required workflow.
    • Track and organize incoming requests for support.
    • Liaise with the franchise business colleagues when appropriate to further vet requests received for support.
    • Liaise with requesting organizations and appropriate multi-functional internal team to coordinate Celgene's participation in funded events or programs.
    • Facilitate resolution of any conflicts.
    • Manage and document deviations.
  • Compliance review of all patient advocacy and copay foundation grant requests, ensure appropriate documentation is provided.
  • Liaise with the Legal Department on potential legal issues, waivers and policy changes.
  • Support the continuous development and improvement of the corporate funding program.
  • Engage with global internal stakeholders including but not limited to Global Corporate Affairs, Medical Affairs, and Commercial on corporate funding requests received.
  • Reporting and Analytics: manage and develop metrics / dashboard associated with corporate funding.

Skills/Knowledge Required:

  • Minimum 5 years of experience in pharma/ biotech business
  • Minimum 3 years healthcare compliance or operations role managing compliance processes or related experience
  • Ability to prepare analytical written and oral communications
  • Attentive to detail and task oriented
  • Strong interpersonal skills
  • Ability to interact cross-functionally at all levels internally within Celgene, and externally with grant applicants
  • Ability to serve as a resource and intercede in resolving critical issues
  • Ability to draft clear and concise written correspondence
  • Ability to work independently, multitask, and self-prioritize workload under tight deadlines
  • Ability to understand and work with funding support systems
  • An understanding of quality systems and document management would be considered an advantage

Key Competencies

  • Role model for ethical behaviour
  • Highest level of integrity and able to protect confidential information
  • Personal and professional maturity
  • Negotiation, collaboration, persuasion, communication and relationship building skills
  • Ability to work in a highly matrixed organization
  • Time management skills
  • Ability to work with cross-functional teams and partners
  • Excellent investigational and problem solving skills

Forward Resume to Michael Kim, Executive Director, Compliance mikim@Celgene.com.
Please indicate in the subject line which position you are applying for.

About Celgene
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

Equal Employment Opportunity
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S. Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee's temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.

Posted 6/6/17


 

SENIOR MANAGER, HEALTHCARE COMPLIANCE MONITORING & AUDITS - GLOBAL COMPLIANCE GROUP - Celgene Corporation
LOCATION: SUMMIT, NEW JERSEY


Prerequisites:

  • Completed Bachelor's degree from an accredited undergraduate institution required.
  • 10+ years of healthcare compliance ("HCC") monitoring and/or auditing experience with a global life sciences company or accounting/consulting firm with emphasis in life sciences.
  • Currently possessing at least one of the following audit certifications: Healthcare Compliance Certification; CIA; CPA; CFE.
  • Extensive knowledge and understanding of applicable HCC laws and guidance; including but not limited to OIG guidelines, AMA guidelines, PhRMA Code, Corporate Integrity Agreements, and global anti-bribery/anti-corruption laws, including but not limited to the FCPA.

Summary
This position will be responsible for executing the healthcare compliance ("HCC") monitoring program and performing audits of compliance with U.S. federal and state laws and regulations related to the promotion, sale and marketing of Celgene's products; similar HCC requirements outside the United States; global anti-bribery/anti-corruption laws, including but not limited to the FCPA; and Celgene's policies relating to the foregoing (collectively "HCC Rules").

Responsibilities will include, but are not limited to the following under the direction of and in collaboration with their Manager:

  • Remain informed of developments in applicable HCC Rules and enforcement trends
  • Serve as subject matter expert and provide expertise and advice to business partners regarding HCC issues
  • Manage the process of assessing and monitoring HCC risks; Develop and execute HCC monitoring programs, including the performance of field rides
  • Plan and independently execute audits to evaluate compliance with HCC Rules
  • Design and deliver meaningful, accurate and effective presentations to senior management and ensure follow-up on any areas that require corrective action
  • Manage and maintain the HCC monitoring and audit observation and remediation plan database
  • Assist in the development of the annual risk assessment and audit plan
  • Contribute to the development, implementation, and maintenance of Standard Operating Procedures
  • Partner with Global Compliance, Legal, Internal Audit, and Finance teams in carrying out monitoring and audit activities
  • Multi-task required work for the role in addition to leading, managing, and executing ad-hoc compliance projects as assigned
  • Supervise and provide guidance to unit colleagues beyond just a team/audit/project setting.
  • May mentor colleagues and be viewed as a leader/mentor
  • Significant domestic and international overnight travel required, up to approximately 25%

Skills/Knowledge Required:

  • Demonstrable knowledge and understanding of all applicable HCC Rules
  • Considers and incorporates global perspectives and requirements
  • Proven ability to build, execute, and manage HCC monitoring programs independently
  • Proven ability to build and execute audit plans and conduct HCC audits with minimal supervision
  • Proven ability to lead cross-functional and diverse teams and participate constructively in multidiscipline teams
  • Advanced data analytics and data mining skills
  • Strong project management skills; drives execution
  • High level problem solving, discretion/judgment, detail-oriented and confidentiality; comfortable with ambiguity and can adapt style and tactics based on situation
  • Strong interpersonal skills; must be able to forge strong relationships with all levels of the organization
  • Ability to effectively prepare and present analytical written and oral communications appropriate for multiple audiences and levels within the organization
  • High level of influencing skills and ability to drive change as it relates to implementing remedial actions; balances diplomacy and respectfulness with assertiveness

Preferred Skills/Experience:

  • Currently possessing more than one of the following audit certifications: Healthcare Compliance Certification; CIA; CPA; CFE
  • Completed graduate degree in a field directly-related to the business needs of this position and/or an MBA or JD
  • Experience in consulting firm advising on Pharmaceutical industry HCC related issues and implementations
  • Experience in Regulatory Affairs, FDA, or pharmaceutical Sales and Marketing, IT and financial auditing also a plus
  • Experience with Oracle, Basware, Concur, TeamMate, Tableau, and/or Qlikview a plus

Forward Resume to Michael Kim, Executive Director, Compliance mikim@Celgene.com.
Please indicate in the subject line which position you are applying for.

About Celgene
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

Equal Employment Opportunity
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S. Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee's temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.

Posted 6/6/17


 

DIRECTOR, CORPORATE POLICIES - Celgene Corporation
LOCATION: SUMMIT, NEW JERSEY
SUPERVISOR: Executive Director, Corporate Compliance
DEPARTMENT: Global Compliance Group
PREREQUISITES: Qualified professional with minimum of 7-10 years of life science industry experience with related compliance policy writing experience required. Minimum of Bachelor's degree from an accredited undergraduate institution.


Core Responsibilities:
The Director, Corporate Policies, will be responsible for authoring, editing, updating, and publishing Celgene's Corporate Policies to ensure that such policies are clear, concise and assessable to all Celgene employees and contractors worldwide. The Director will be tasked with forming and leading a core team for each policy that is comprised of key stakeholders and subject matter experts with representation from relevant functions, departments and regions or countries where Celgene does business. The Director will work closely with other team members within Global Compliance to identify key implementation elements and create an implementation plan. The Director, together with the respective core teams, will present the Celgene Policies to the Corporate Policy Committee for review and approval.

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

  • Authoring, editing, updating, and publishing Celgene's Corporate Policies;
  • Forming and leading a core team for each respective policy comprised of key stakeholders, subject matter experts and representation from relevant functions, departments and Celgene office locations.
  • Working closely with Global Compliance team to identify implementation elements and create an effective implementation plans for such Corporate Policies.
  • Present the revised or updated Celgene Policies to the Corporate Policy Committee for review and approval.
  • Analyzing and mapping Corporate Policies and related SOPs to ensure policies are consistent, cross-referenced, and are properly identified and maintained.
  • Ensuring that consistent taxonomy is used throughout the Corporate Policies.
  • Operating as the primary point of contact for questions regarding the Corporate Policies.
  • Performing other compliance-related activities as directed by the CCO.

Qualifications:

  • A minimum of a Bachelor's Degree from an accredited undergraduate institution.
  • A minimum of 7-10 years of life sciences industry experience with compliance policy writing related experience required.
  • Strong business writing skills. Writing sample required.
  • Proven ability to directly manage the work of others on ad hoc teams.
  • Demonstrated ability to work cross-functionally and collaboratively with US and ex-US colleagues

Competencies Required

  • Leadership, Cross-Functional Execution/Teamwork and Positive Working Relationships, Analytical and Problem-solving, Strategic, Strong Business Acumen, Technical/Professional Knowledge, Planning and Organizing, Strong Communication Skills, Operational Capabilities, Budget Management, Ongoing Listening and Learning.

Forward Resume to Michael Kim, Executive Director, Compliance mikim@Celgene.com.
Please indicate in the subject line which position you are applying for.

About Celgene
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

Equal Employment Opportunity
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S. Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee's temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.

Posted 6/6/17


 

SR. MANAGER, US HEALTHCARE COMPLIANCE (HCC) LEARNING AND COMMUNICATIONS - Celgene Corporation
LOCATION: SUMMIT, NEW JERSEY
SUPERVISOR: VP, US Healthcare Compliance Officer
DEPARTMENT: Global Compliance


PREREQUISITES:

  • Bachelor degree; advanced degree - preferred
  • Fluency in English
  • Compliance and regulatory knowledge in related commercial or medical functions
  • Minimum of 10 years training experience
  • Minimum of 7 years of experience and demonstrated leadership in HCC or related compliance function (HCC, Privacy, regulatory, quality, legal) - preferred
  • Minimum of 3 years of line management experience in the pharmaceutical and/or medical device industries - preferred

Summary / Scope:
Responsible for strategic planning and execution of US HCC learning and communications for Hem/Onc and I&I Franchises (Commercial and Medical Affairs). Designs, develops and provides live training to field and non-field US colleagues (excluding Global functions but working collaboratively with International HCC Training function(s)). Also responsible for execution of US HCC communications for all US based colleagues. Creates awareness for Compliance Program.

Responsibilities include, but are not limited to:

Strategy & Planning

  • Provides the critical and strategic thinking required to proactively plan and build the Healthcare Compliance (HCC) training program across the US organization; and directly responsible for tactical implementation of the training program within the USA. Partners with the International HCC team and Global Compliance Learning and Communication function to harmonize, where appropriate, on strategy, content and execution.
  • Utilizes results of risk assessments, new or updated local regulations, and updated internal policies or procedures, to assess training needs
  • Identifies areas of improvement on existing programs, recommends need for new policies, procedures, and training curriculum and implements enhancements or changes to ensure business compliance effectiveness.

Execution

  • Develops and maintains all course content, audio/visual aids, handouts, learning aids, communications, as required to provide continued training tools and resources for shared materials
  • Provides live training to field and non-field US colleagues.
  • Maintenance of all training programs/systems; creates, publishes and utilizes metrics and status reports to measure the effectiveness of the training program, including periodic training reports.

Communications

  • Remains current and monitors sources of regulatory updates and industry best practices, including but not limited to US enforcement activity trends, Spend Transparency laws / codes, applicable US laws and codes, and disseminates necessary information to affected business partners and/or incorporates into training content updates and training program.
  • Enhances the culture of integrity and compliance by leading efforts with Global Corporate Communications and Global Compliance teams to develop and deliver HCC communications to promote continued awareness.
  • Establishes and develops relationships with business leaders, including but not limited to commercial, medical, regulatory, legal and compliance to drive the HCC US training strategy implementation and execution.

Key Requirements:

  • Minimum 10 years of experience in pharma/ biotech related to development of training programs, curriculum development, and learning management systems
  • Proven ability to develop training materials, conducting workshops, classroom, and remote/online training; knowledge of training techniques and practices
  • Knowledge and experience developing a complex US strategic training program
  • Knowledge in developing and executing strategic communication plans
  • Ability to research, develop, write, and effectively communicate information within a health care compliance environment
  • Knowledge of US laws, regulations, industry guidance and best practices regarding compliant sales, marketing, and medical activities
  • Understanding of process for defining and implementing policies, procedures and SOP's
  • Working with cross-functional teams
  • Ability to work independently to build and execute training program
  • Ability to work with cross-functional teams and partners
  • Excellent verbal, written, presentation, and other communication skills
  • Ability to fully engage various audiences
  • Proficiency in Microsoft Office is required
  • Proficiency in learning management systems
  • Must be self-motivated and possess strong interpersonal skills

Competencies:

  • Documentation management
  • Highest level of integrity and able to protect confidential information
  • Subject matter knowledge of healthcare compliance
  • Negotiation, collaboration, persuasion, communication and relationship building skills
  • Role model for ethical behaviour
  • Multi-tasking
  • Ability to work in a highly matrixed organization
  • Personal and professional maturity
  • Ability to prioritize
  • Time management skills
  • Ability to work independently

Direct and Indirect Reports: None
Travel: Position may require limited (~25%) domestic travel.

Forward Resume to Michael Kim, Executive Director, Compliance mikim@Celgene.com.
Please indicate in the subject line which position you are applying for.

About Celgene
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

Equal Employment Opportunity
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S. Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee's temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.

Posted 6/6/17


 

SR. MANAGER, US HEALTHCARE COMPLIANCE (HCC) POLICY - Celgene Corporation
LOCATION: SUMMIT, NEW JERSEY
SUPERVISOR: VP, US Healthcare Compliance Officer
DEPARTMENT: Global Compliance


PREREQUISITES:

  • Bachelor degree; advanced degree - preferred
  • Compliance and regulatory knowledge in related commercial or medical functions
  • Minimum of 10 years Policy/Procedure development experience (or equivalent)
  • Global cross-functional and/or cross-sector experience - required
  • Minimum of 7 years of experience and demonstrated leadership in HCC or related compliance function (HCC, Privacy, regulatory, quality, legal) - preferred
  • Minimum of 3 years of line management experience in the pharmaceutical and/or medical device industries - preferred

Summary / Scope:
Develop and author, maintain, and revise US HCC related procedures (SOPs), guidance and other controlled documents. Responsible for being subject matter expert in process design; driving efficiency, and designing controls to mitigate risk. Collaborate and partner with key stakeholders to ensure appropriate and timely implementation of such procedures. Partner with other Compliance colleagues to identify areas of opportunity for continuous improvement of process and written procedural documents.

Responsibilities include, but are not limited to:

  • Identify need for written procedural documents (in anticipation of need and in response to need) with primary focus on development and enhancement of implementing SOPs related to Corporate Policy requirements
  • Identify who will take lead responsibility for procedural development (individual, working group, sub-committee, etc.)
  • Gather background information, coordinate/author draft procedure, consult with stakeholders, finalize and secure approvals
  • Assure efficient implementation
  • Monitor, review and revise as necessary.

Key Requirements:

  • Minimum 10 years of experience in pharma/ biotech related to development of procedural documents and/or Quality Management Systems in general
  • Proven ability to develop procedural documents, conduct workshops, classroom, and remote/online communications.
  • Ability to research, develop, write, and effectively communicate information within a health care compliance environment
  • Knowledge of US laws, regulations, industry guidance and best practices regarding compliant sales, marketing, and medical activities
  • Understanding of process for defining and implementing policies, procedures and SOP's
  • Working with cross-functional teams and partners
  • Ability to work independently to build and execute SOP development program
  • Excellent verbal, written, presentation, and other communication skills
  • Proficiency in Microsoft Office is required
  • Must be self-motivated and possess strong interpersonal skills

Competencies:

  • Documentation management
  • Highest level of integrity and able to protect confidential information
  • Subject matter knowledge of healthcare compliance
  • Negotiation, collaboration, persuasion, communication and relationship building skills
  • Role model for ethical behaviour
  • Multi-tasking
  • Ability to work in a highly matrixed organization
  • Personal and professional maturity
  • Ability to prioritize
  • Time management skills
  • Ability to work independently

Direct and Indirect Reports: None
Travel: Position may require limited (~10%) domestic and international travel.

Forward Resume to Michael Kim, Executive Director, Compliance mikim@Celgene.com.
Please indicate in the subject line which position you are applying for.

About Celgene
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

Equal Employment Opportunity
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S. Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee's temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.

Posted 6/6/17


 

ASSOCIATE DIRECTOR, HEALTHCARE COMPLIANCE MONITORING - Celgene Corporation
LOCATION: SUMMIT, NEW JERSEY
SUPERVISOR: Director, Healthcare Compliance Audits (or higher level)
DEPARTMENT: Compliance Audit and Inspection Group, Global Compliance


PREREQUISITES:

  • Completed Bachelor's degree from an accredited undergraduate institution required.
  • 10+ years of healthcare compliance ("HCC") monitoring and/or auditing experience with a global life sciences company or accounting/consulting firm with emphasis in life sciences.
  • Currently possessing at least one of the following audit certifications: Healthcare Compliance Certification; Certified Internal Auditor; Certified Public Accountant; Certified Fraud Examiner.
  • Extensive knowledge and understanding of applicable HCC laws and guidance; including but not limited to OIG guidelines, AMA guidelines, PhRMA Code, Corporate Integrity Agreements, and global anti-bribery/anti-corruption laws, including but not limited to the FCPA.

Summary:
This position will be responsible for carrying out the Healthcare Compliance Monitoring Program and Annual Healthcare Compliance Monitoring Operating Plans. The Healthcare Compliance Monitoring Operations scope will include monitoring compliance with U.S. federal and state laws and regulations related to the promotion, sale and marketing of Celgene's products and interactions with and payments to healthcare professionals; similar healthcare compliance requirements outside the United States; global anti-bribery/anti-corruption laws, including but not limited to the FCPA; and Celgene's policies relating to the foregoing (collectively "HCC Rules"), with an emphasis on financial systems as they relate to the foregoing. In addition, this position will be responsible for incorporating the Global Analytics program and expertise into the Healthcare Compliance Monitoring Program.

Core Responsibilities:

  • Leads the development of the annual monitoring risk assessment and monitoring plan (including risk assessments, monitoring activities, etc.)
  • Manage the execution of HCC monitoring programs, including but not limited to: Grants, Donations, & Sponsorships, Healthcare Professional Fees for Services, Medical Information Requests, Speaker Programs, Live Monitoring (Speaker Programs, Ride-A-Longs, & Advisory Boards).
  • Manages or leads Healthcare Compliance Monitoring projects and services provided by external vendors
  • Partner with Key Stakeholders including but not limited to Franchise Leadership, Global Compliance, Legal, and Finance teams in carrying out monitoring activities
  • Design and deliver meaningful, accurate and effective presentations to senior management and ensure follow-up on any areas that require corrective action
  • Manage and maintain the HCC monitoring and remediation plan database
  • Drive innovation within the functional area through data analytics and system automation; develop and implement initiatives to enhance customer value and strengthen regulatory compliance
  • Manage the development, implementation, and maintenance of Standard Operating Procedures
  • Develop the department training plan; trains and develops junior staff
  • Mentors and facilitates successful team behavior within and across functional areas; provides leadership to discipline team members regionally
  • Multi-task responsibilities outside the bounds of one's responsible unit
  • Responsible for the Healthcare Compliance Monitoring function spending
  • Assists in unit hiring decisions
  • Back up to Director/Senior Director role.

Key Requirements:

  • Deep subject matter expert on HCC regulations and enforcement trends
  • Extensive technical and compliance monitoring knowledge and experience, at an expert level
  • Proven ability to build, execute, and manage HCC monitoring programs independently
  • Advanced data analytics and data mining skills
  • High level problem solving, discretion/judgment, detail-oriented and confidentiality; comfortable with ambiguity and can adapt style and tactics based on situation
  • Strong interpersonal skills; must be able to forge strong relationships with all levels of the organization
  • High level of influencing skills and ability to drive change as it relates to implementing remedial actions; balances diplomacy and respectfulness with assertiveness
  • Ability to effectively prepare and present analytical written and oral communications appropriate for multiple audiences and levels within the organization
  • Considers and incorporates global perspectives and requirements

Preferred Skills/Experiences:

  • Currently possesses more than one of the following audit certifications: Healthcare Compliance Certification; Certified Internal Auditor; Certified Public Accountant; Certified Fraud Examiner
  • Completed graduate degree in a field directly-related to the business needs of this position and/or an MBA or JD
  • Experience in consulting firm advising on Pharmaceutical industry HCC related issues and implementations
  • Experience in Regulatory Affairs, FDA, or Pharmaceutical Sales and Marketing, IT and Financial Auditing also a plus
  • Experience with Data Analytics Tools (Tableau, Qlikview, etc.), Oracle, OBIEE, Basware, Concur, and TeamMate

Direct and Indirect Reports: May manage one or more direct reports
Travel: Limited domestic and international overnight travel required, up to approximately 5%

Forward Resume to Michael Kim, Executive Director, Compliance mikim@Celgene.com.
Please indicate in the subject line which position you are applying for.

About Celgene
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

Equal Employment Opportunity
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S. Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee's temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.

Posted 6/6/17