The Pharmaceutical Compliance Forum

Employment

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EMPLOYMENT OPPORTUNITIES


 

MANAGER/SENIOR MANAGER COMPLIANCE GENERALIST - United Therapeutics Corporation

The Manager/Senior Manager Compliance Generalist owns various tactical operations and full project management of various initiatives and systems within the compliance program. This includes internal company-wide communications; assisting with monitoring and auditing aligned with strategic plans, and creating reports for internal and external business partners to implement effective compliance controls.

Key Accountabilities / Responsibilities:

  • Facilitate activities to complete deliverables within timelines, using judgment to troubleshoot and/or escalate issues to VP Compliance as necessary
  • Manage and prioritize multiple complex projects; collaborating with multi-functional subject matter experts and stakeholders as required
  • Prepare and provide reports, presentations, materials, guidelines, and documents in response to internal and external inquiries
  • Create tracking tools and provide accurate tracking reports related to project management initiatives, as well as external government inquiries and corporate integrity agreement requirements
  • Support compliance monitoring and auditing initiatives via live and backend activities
  • Assist with federal/state aggregate spend activities via accurate analysis and output of reportable spend under guidance of Senior Director
  • Assess fair market value of various activities, including but not limited to: Commercial, Medical Affairs, and Clinical Research
  • Create and maintain Compliance intranet site
  • Draft company-wide communications related to Compliance Program initiatives or enhancements
  • Assist with creation or revision of Corporate Compliance policies and procedures
  • Assist with the evaluation and creation of internal training materials, including working with third party training vendors to create such materials
  • Maintain current knowledge of changes, trends, rules, regulations, and industry guidance impacting pharmaceutical commercial activities; including FDA regulations, OIG guidance, and the PhRMA Code
  • Develop and demonstrate knowledge and competency to serve as a compliance and ethics subject matter expert
  • Perform other duties as assigned

Minimum Requirements:

  • Bachelor's degree in Business, Finance, Life Sciences or healthcare related field
  • 7 years of experience in the biopharmaceutical industry, including 5 years in a compliance role
  • Proficiency with MS Office suite, and with databases to track report, and present monitoring and auditing data
  • Strong knowledge of and ability to function within corporate integrity agreement environment to meet needed requirements
  • Ability to travel as needed up to 40%

Preferred Knowledge, Skills, and Abilities:

  • Healthcare or Corporate Compliance Certification program; PMI/Lean Six Sigma preferred
  • Organized and detail-oriented with excellent communication skills
  • Solid knowledge of compliance program structures within the biopharmaceutical industry in accordance with OIG guidelines, PhRMA and FDA legal requirements, healthcare compliance law, and related regulations
  • Strong project management experience with ability to work independently, act with urgency and high motivation, and interact with personnel at all levels and across all functions

United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities

  Apply here
Posted 9/22/2017


 

DIRECTOR/SENIOR DIRECTOR OF COMPLIANCE MONITORING, AUDITING, AND INVESTIGATIONS - United Therapeutics Corporation


Position Overview
As the Director/Senior Director of Compliance Monitoring, Auditing, and Investigations you will oversee the development and execution of all monitoring and auditing activities, including conducting the annual risk assessment. Additionally, you will be responsible for the investigations process, database/hotline, and timelines, as well as the third party due diligence process.

Key Accountabilities / Responsibilities:

  • Conduct annual risk assessment to develop the auditing and monitoring plans, making adaptions consistent with dynamic business risks as needed
  • Conduct monitoring of Sales, Marketing, Medical Affairs, and R&D activities from a corporate compliance perspective; identifying potential areas of vulnerability and risk, and providing guidance on handling and avoiding such situations
  • Develop and implement corrective action plans in partnership with functional leadership for resolution of problem areas or gaps
  • Manage live and online auditing and monitoring, including metrics and meaningful reporting for committee meetings. Strategically select auditing and monitoring samples and identify trends and potential risks as necessary
  • Recognize and respond to compliance issues in a timely manner; following up to resolve and improve processes
  • Own and continually improve due diligence process, including related government documents and relevant system and cross-functional alignment
  • Manage all investigations and related processes, collaborating with relevant members of management, legal, HR, and other departments to ensure appropriate outcomes, and serving as a touchpoint for investigations committee members
  • Perform other departmental duties as assigned

Minimum Requirements:

  • Bachelor’s degree in Business, Finance, Life Sciences or another healthcare-related field
  • 10+ years in pharmaceutical/biotechnology industry
  • 7+ years in Audit/Corporate Compliance roles
  • Knowledge of regulatory/compliance requirements (anti-kickback statute, False Claims Act, FCPA, Sunshine Act)
  • Ability to detect and present trends/patterns in auditing, monitoring, and investigations findings
  • Experience developing, deploying, and maintaining compliance program policies
  • Proficiency in Microsoft Office with Advanced Excel, PowerPoint, and database skills
  • Ability to travel as needed up to 40%

Preferred Knowledge, Skills, and Abilities:

  • Master's degree or Juris Doctorate preferred
  • Organized and detail-oriented with excellent communication skills
  • Ability to build relationships with internal customers
  • Success in operating under a corporate integrity agreement by meeting all government reporting requirements while balancing with business continuity
  • Ability to act with urgency and high motivation, taking initiative and following up to complete projects professionally and timely

United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities

  Apply here
Posted 9/22/2017


 

SENIOR MANAGER COMPLIANCE (167544) - Allergan plc
HM: Timothy Roberts

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
Under limited direction, the Senior Manager partners with the US Commercial organization and others within the Compliance organization to understand business priorities and provide compliance support on strategy, tactics and operations. This position is responsible for the evaluation of Commercial programs / activities and helping to design and deliver innovative solutions that support the vision, values and corporate goals of the Company, and provides guidance to help achieve goals while mitigating risk to the assigned organizations. Also ensures harmony across the US organization as a member of a broader US Commercial Compliance Team.

Primary Job Responsibilities: Within assigned commercial business units, the position responsibilities include providing compliance support related to various business activities, with a primary focus on interactions with healthcare professionals for training and consultative activities as well as effective execution of selling and marketing initiatives. Examples include, but are not limited to, routine interactions with healthcare professionals, planning and execution of various healthcare professional engagements and professional educational activities, cross-functional collaboration initiatives, as well the development and delivery of compliance training at meetings and events. Responsible for providing support to Monitoring and Investigations as needed. Assists Compliance leadership with strategic initiatives within US Commercial Compliance to ensure adherence to internal policies and procedures and federal and state requirements.

Core Competencies:

  • Collaboration: Partner with multiple internal and external stakeholders in the development of strategic initiatives related to business goals
  • Training: Train business partners on compliance guidelines, policies and best practices related their specific business.
  • Guidance: Provide regular guidance to the business regarding the Global Compliance Program
  • Reporting: Provide strategic insights to business partners based on compliance data analysis
  • Problem Solving: Provide innovative solutions to mitigate risk while supporting business goals and objectives
  • Business Knowledge: Develop a comprehensive understanding of the products, initiatives and goals of the business.

Essential Job Functions:

  • Provide timely and practical advice and support for questions and concerns regarding compliant activities
  • Provide strategic and tactical support of key business operations functions and Centers of Excellence
  • Partner with members from Sales, Marketing, Legal, Business Operations, HR and Medical Affairs departments for compliance-related activities.
  • Develop and deliver regular and ongoing training and education to the Commercial organization
  • Provide data analytics and reporting related to monitoring findings and other compliance observations to internal stakeholders as well as external regulators
  • Assist and provide input to compliance audits, monitoring and internal investigations as needed

Required Knowledge:
Awareness of federal fraud and abuse laws and guidance, including the ACCME guidelines, the Office of Inspector General reports, and the Food, Drug and Cosmetic Act and an understanding of the roles and authority of government agencies and industry partners including FDA, OIG, PhRMA and AdvaMed.

Positions Qualifications:

  • Bachelor's degree required; advanced degree preferred
  • 5-7 years of experience in Compliance, with 2-3 years of experience in the pharmaceutical or medical device industry preferred
  • Prior experience in business/customer facing role required
  • Prior experience managing projects.

  Apply here
Posted 9/11/2017


 

MANAGER COMPLIANCE INVESTIGATIONS (Req 167545) - Allergan plc
HM: Carol Sweeney

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 Manager, Compliance Investigations, will support the Global Investigations function and the HealthCare Compliance Audit team and report directly to the Associate Director, Compliance Investigations.

The Manager's responsibilities include conducting and/or supervising complex activities associated with the implementation and maintenance of various audit and investigation processes and various other corporate programs. In addition, this position will assist with the management of various projects based on the needs of the Compliance Department.

  1. Demonstrate enterprise-wide lateral leadership when conducting compliance investigations involving potential violations of local, state, and federal laws, violations of company policy/procedure and/or company global Code of Conduct.
  2. Analyze data and supporting documentation to assess the validity of compliance allegations, and aggregate results to provide strategic insight into allegation trends.
  3. Conduct interviews of the reporter, and others to gather facts and obtain statements regarding the allegation(s).
  4. Manage entries to Disclosure Log and Potential Issue Investigation information for CIA.
  5. Provide regular reports including investigation outcomes, status updates and recommendations to Compliance Leadership team and Disciplinary Review Committee.
  6. Maintains strict professional, ethical, legal adherence and confidentiality at all times.
  7. Provide updates and reports on a regular basis to the Associate Director, Compliance Investigations, and as requested to the Global Chief Compliance Officer, on the operation and progress of investigation outcomes, and project status updates.
  8. Provide investigative support to other business functions as needed.

Education:
Bachelor's Degree required, advanced degree a plus.

Experience:
4 -6 years of professional experience in the areas of internal and/or external audit/investigation/monitoring in a pharmaceutical and life sciences industry.

Licensure/Credentials:
Compliance and fraud related certifications a plus (e.g. CCEP, CFA, CPA)

  Apply here
Posted 9/11/2017


 

ASSOCIATE DIRECTOR COMPLIANCE TRAINING (167546) - Allergan plc

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 Associate Director's responsibilities include supporting the Company's Corporate Compliance function with special emphasis and focus on leading Compliance training initiatives. Additionally, this position will support Compliance related policies and procedures, and Compliance communications. This position will also serve as a liaison to internal and external business partners, providing direction and guidance related to Allergan's Compliance program. This position requires an individual with strong capabilities in creating and executing training programs globally using various delivery tools and current adult learning methods for our multi-generational and multi-cultural nature of colleagues.

  1. Support leadership team in making recommendations on enterprise wide Compliance programs, including training adherence and effectiveness.
  2. Develop and execute the global training strategy for compliance related topics using innovative techniques to increase the understanding and application of the core values of our company.
  3. Apply appropriate training techniques across multiple platforms to engage colleagues in an effective and efficient manner.
  4. Inspire others to follow the established direction for the organization. Identify areas of opportunity to enhance compliance through effective training programs and communication.
  5. Identify, deliver and present issues to management with proactive recommendations on addressing the issues
  6. Provide regular updates and reports to management on Compliance projects and training initiatives.
  7. Integrate compliance controls into the scope of existing business practices company-wide
  8. Maintain corporate compliance policies that are clear, concise and values based.
  9. Serve as subject matter expert to internal and external stakeholders for a variety of compliance functions, including policies and training content and systems
  10. Support specific critical special projects that are aimed at increasing compliance while simplifying business processes.
  11. Oversight of relationships with third party vendors and business partners to help ensure adherence to our Compliance program
  12. Maintain strict ethical, legal adherence and confidentiality at all times

Education:
Bachelor's degree is required, advanced degree a plus.

Experience:
Minimum 8-10 years Corporate Compliance in the pharmaceutical and life sciences industry, or similar transferable experience. Three or more years of experience related to adult learning in a corporate environment. Experience in field sales, marketing or regulatory/legal also a plus.

  Apply here
Posted 9/11/2017


 

COMPLIANCE OPERATIONS ASSOCIATE DIRECTOR - EXELIXIS
Location: SSF
Salary Grade: 11
Division: G&A
Job Code: TBD
Department: 10015 Compliance
FLSA Status: X Exempt
Reports To: VP, Compliance
Effective Date: September 2017


SUMMARY:
The Compliance Operations Associate Director will be responsible for leading the development, implementation, and continuous improvement of healthcare compliance practices, systems, and processes, with an emphasis on business integrity, operational excellence, and practicality. One primary focus will be overseeing and enhancing the Company's healthcare compliance audit and monitoring program and establishing the strategy and infrastructure needed to enable the company to track and evaluate compliance of its ongoing activities. To that end, this position will be responsible for evaluation of materials submitted for review and approval, performing audits of and monitoring of interactions with the healthcare community, and facilitating internal reporting. Of similar priority will be management of the process for tracking and reporting HCP spend. Furthermore, this position will be responsible for supporting governance committee meetings. The essential business partners for this function are corresponding positions in Sales, Marketing, Medical Affairs, HR, IT, and Finance.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Works on a range of departmental and/or strategic problems where analysis of situations or data requires critical thinking, an in-depth evaluation, and company knowledge of various factors. May also be required to manage external consultant engagements, when needed, including overall budgets, schedules, and performance standards.
  • Responsible for overseeing the successful implementation and execution of the audit and monitoring program, including development of tools, performance standards, and completion of corrective action. In taking ownership of the program, the team lead will need to be strategic partner with Commercial, Medical Affairs, and Development to ensure that the program evolves as the company grows.
  • Leads the ongoing fulfillment of the company's HCP spend tracking and reporting obligations under the ACA's Sunshine Act provisions and related state laws regulating HCP spend by drug manufacturers or requiring state tracking and reporting. Applies advanced technical expertise in this arena and supports goals with an understanding of priority and impact to the program, department and organization.
  • Acts as a consultant, reviewer and legal/compliance approver as needed, for business activities that involve Healthcare Compliance risks, and contributes to departmental process and organizational improvements and development, including management of the contract request process for HCP engagements. In addition, participates in reviews of requests for approval of advisory board meetings, speaker programs, and other Commercial, Medical Affairs, and Development activities.
  • Supports senior management governance committee meetings (e.g., Ethics Committee and Healthcare Compliance Committee) by presenting compliance updates on key initiatives and reporting metrics from the audit and monitoring program as well as any investigations.
  • Assists with the company's Healthcare Compliance continuous improvement initiatives, including but not limited to, the update, maintenance and consistent implementation of policies and SOPs.
  • Leverages data analytic skills to proactively address potential healthcare/FDA compliance issues to prevent or minimize compliance risk to the company. Works with internal stakeholders to achieve business goals within a compliance framework.
  • Participates in the investigation of complaints and alleged violations of rules, regulations, policies, procedures, and standards of conduct, and coordinates with management in developing/implementing corrective action plans, and providing general guidance on such matters.
  • Regularly reviews reports of new compliance developments from governmental agencies such as the OIG and state agencies, including fraud alerts, special advisories or proposed rules and, in conjunction with the legal department, to ensure appropriate interpretation and training regarding such developments.

SUPERVISORY RESPONSIBILITIES:

  • NONE

EDUCATION/EXPERIENCE/SKILLS:

Education:

  • BS/BA degree in related discipline and twelve years of related experience; or,
  • MS/MA degree in related discipline and ten years of related experience; or,
  • Equivalent combination of education and/or experience.

Experience:

  • Specific expertise in the best practices of healthcare compliance and auditing. Finance audit experience a plus.
  • Familiarity with the legal principles of FDA advertising and promotion regulations, the False Claims Act, Anti-Kickback Statute, OIG guidance, and the PhRMA Code required.

Knowledge/Skills/Abilities:

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

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

  Apply here
Posted 9/7/2017


 

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