The Pharmaceutical Compliance Forum

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EMPLOYMENT OPPORTUNITIES

 

SENIOR COMPLIANCE OPERATIONS MANAGER - EXELIXIS
Salary Grade: 9
Location: Alameda
Jode Code: TBD
Division: G&A
FLSA Status: Exempt
Department: 10015 Compliance
Effective Date: August 2018
Reports To: VP, Compliance


SUMMARY:
The Compliance Operations Senior Manager will be responsible for 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 supporting Development and Medical Affairs on healthcare compliance, anti-bribery/anti-corruption, privacy and data management issues. As part of this support, this position will be responsible for evaluating materials submitted for review and approval, performing audits, and conducting training related to interactions with the healthcare community. Another responsibility will be management of the process for tracking and reporting HCP spend. Of similar priority will be supporting and enhancing the Company's healthcare compliance monitoring program. The essential business partners for this function are corresponding positions in Development, Medical Affairs, Commercial, QA, 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.
  • 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.
  • Support execution of the audit and monitoring program, including development of tools, performance standards, and completion of corrective action. In conducting compliance assessments, the team lead will need to be a strategic partner to R&D to ensure that the compliance program evolves as the company grows.
  • 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 Medical Affairs and Development activities.
  • Assists with the company's Healthcare Compliance continuous improvement initiatives, including but not limited to, partnering with Quality Assurance to develop processes and training related to healthcare compliance, corruption, privacy and data management risks. GxP experience is a plus.
  • 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 seven years of related experience; or,
  • MS/MA degree in related discipline and five 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 is 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.
  • Experience with Polaris software and/or Tableau is a plus.
Knowledge/Skills/Abilities:

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

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

 Apply here
Posted 8/22/2018

ETHICS & COMPLIANCE PARTNER - UCB


Help us transform patients' lives.

At UCB, we put our heart, soul and skills into making a difference for people living with severe disease. Working together to push the boundaries, we blend the best of our talents to unlock innovation. Will you join us in our pioneering adventure?

To strengthen our Ethics & Compliance team, we are looking for an Ethics & Compliance Partner.

Are you an Ethics & Compliance expert looking to make an impact on the lives of patients?

As an Ethics & Compliance Partner you will work in an environment where you will:

Be the front-line representative of E&C organization, and represent E&C in a responsible and professional manner while acting as a strategic business partner.

This role is responsible for providing subject matter expertise and leadership on compliance-related matters within the organization, ensuring that the supported Patient Value organization is educated on Ethics & Compliance standards, informed about Ethics & Compliance related risks, helping minimize those, building Ethics & Compliance by design in their initiatives and guiding their personnel through global processes, connecting them with local stakeholders as needed.

This role will be responsible to oversee regional initiatives and connect with local Ethics & Compliance colleagues, ensuring appropriate flow of information; connecting with E&C peers through formal and informal collaboration networks to ensure consistent application of E&C approaches and efficient sharing of best practices.

As the Ethics & Compliance Partner you will contribute by:
Maintaining thorough knowledge of all industry codes, laws, regulations, and monitor key developments that would impact the business. In collaboration with colleagues, advise the business regarding existing and future provisions. For future provisions, ensure appropriate planning and preparation where it will impact the business.

Drive risk assessments for compliance in the supported organization, informed by adequate monitoring and analytics, ensuring that key stakeholders are informed on relevant risks and implementing remediation plans, in collaboration with E&C Leadership.

Supporting development of Policies and Procedures as a subject matter expert.

Working with the relevant stakeholders to ensure regional organizations are educated and well informed about ethics & compliance policies and procedures.

Acting as a proactive strategic partner with the business to help them meet their goals and objectives in a compliant manner, analyzing alternatives and proposing solutions.

Co-creating and collaborating on business initiatives to foster innovation and creation of meaningful solutions for patients while ensuring integrity and ethical principles are respected.

Actively engaging the supported organization leadership in driving the tone in integrity from the top and leveraging communication cascaded to the organization to maintain a high level of awareness in ethical business conduct.

Key Stakeholders:

  • Patient Value Units Regional and Missions' teams
  • Patient Value Practices teams
  • PVU/PVP Legal Counsels, Talent and Finance Partners
  • Ethics & Compliance Area/Affiliate teams
  • Ethics & Compliance PVU/PVP partners and Regional Head

Competencies & Proficiency:

  • Demonstrates curiosity and interest in the knowledge and experiences of colleagues
  • Takes accountability for trying out new ideas and approaches
  • Identifies and raises potential delays in project planning, plus their associated risks
  • Builds, integrates and controls project planning, scheduling and resources
  • Effectively communicates with local and regional stakeholders to have an aligned and approved project plan
  • Propose ways of improvement in building and controlling project plans, in terms of accuracy and compliance risks
  • Demonstrates and encourages generosity and helpfulness by sharing knowledge, skills and resources to optimize and improve outcomes
  • Experience working in and being comfortable with matrix organization and reporting lines, and cross-functional teams without clear single leadership

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

  • Bachelor's Degree/Master's Degree preferred
  • Minimum of 3 years of experience in the pharmaceutical industry
  • Experience (direct or indirect - confronted and operated) in healthcare compliance
  • Proficiency in Healthcare Compliance rules and regulations including self-regulated industry codes (PhRMA)
  • Experience in a transnational and multicultural environment
  • Work effectively to design policies, management documents, presentations, control databases, KPI's, and dashboards

 Apply here
Posted 8/20/2018

ASSOCIATE DIRECTOR, CORPORATE COMPLIANCE AND OPERATIONS - Insmed
Department Name: Global Compliance
Manager Name & Title: Tiffany Cumming-Damiani, Executive Director, Corporate Compliance, Policies and Training
Effective Date: May 31, 2018


Supervision of Others: (internal/external):

  • This position reports directly to the Executive Director, Corporate Compliance, Policies and Training
  • This is a non-supervisory position.

General Purpose of Role: Briefly describe, in one or two sentences, the role's primary purpose or contribution to the department or organization.

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

Responsibilities: Following is a list of essential duties, functions and responsibilities. Include key aspects of the role-whether performed daily, weekly, monthly, or annually; and any that occur at irregular intervals.

  • Implement and manage day-to-to operations for the hiring of healthcare professionals including process development, software implementation, fair market value and lifecycle management
  • Implement and manage US transparency program with scalability to global, including oversight of outsourced reporting vendor
  • Support policy and process development, updates and translations as assigned along with any training or communications
  • Partner with the US, EU and Japan businesses to provide guidance and support as needed

Position Requirements: In the following categories, indicate specific role requirements and qualifications that are absolutely necessary in order to perform the essential functions of the job.

Knowledge & Experience

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

Qualifications

  • Bachelor's degree required; advance degree preferred.
  • Compliance certification is a plus
  • At least 7 years' experience in corporate compliance for a pharmaceutical or biotech company

Skills

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

Other (if applicable):

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

 Apply here
Posted 8/17/2018

DIRECTOR, N.A. ETHICS AND BUSINESS INTEGRITY - Sanofi


Position Location: Puerto Rico
The primary purpose of this position is to be the local Compliance business partner in Puerto Rico, establishing and maintaining the compliance program and sitting on the PR management team. This position will report directly into the North America, Ethics & Business Integrity department with a dotted line reporting relationship to the Vice President and General Manager of Puerto Rico.

The professional filling this position will be expected to operate independently, with limited oversight and guidance from North America, Ethics & Business Integrity. As a business partner, a significant portion of time will be dedicated to being the independent and local compliance expert (Policies and Processes) and resource for answering questions and providing guidance to management. This position will develop, implement and execute the local monitoring program as well as develop and deliver compliance training. This position will also perform local analysis of any compliance deviations and coordinate with the North America, Ethics & Business Integrity department on resolution to ensure consistency and will be a local resource to assist in investigations. This position will participate in other ad hoc requirements and projects as they arise.

Primary Roles and Responsibilities:
Independently create relationships with Puerto Rico Senior Management to establish themselves and the department as a trusted business partner and the key resource for compliance questions and guidance. This is a significant and one of the most important aspects of the position as the role will be ineffective without establishing a trusted relationship. Develop, implement, and maintain local compliance program in Puerto Rico

Work with Senior Director, North America Ethics & Business Integrity and Puerto Rico General Manager to develop the framework and structure of local Compliance structure.

Execute local monitoring program in Puerto Rico

  • Leverage the North America Compliance monitoring program to develop and implement a local monitoring of field activity
    • Participate in the random and/or targeted identification of sales representatives to be included in the monitoring process, including communications with selected reps, their direct managers and others as required, and documentation of these activities and coordination with participating members of the NA, Ethics & Business Integrity team.
    • Participate in the random and/or targeted identification of speaker programs to be included in the monitoring process, including communication with sponsoring reps, their direct managers and others as required, and documentation of these activities and coordination with participating members of the NA Compliance team.
    • Periodic field observations of sales representative activities and speaker programs, which will require a strong understanding of US Corporate Policies, and experience interacting with sales force personnel as well as demonstrated ability to think dynamically to answer questions and scenarios
  • Leverage the North America Compliance monitoring program to develop and implement a local monitoring over non filed compliance activity.


Perform / Support local analysis of compliance deviations

  • Perform analysis of compliance deviations that arise and coordinate with North America Ethics & Business Integrity on resolution, action to be taken and documentation.

Conduct Compliance Training

  • Identification of training needs based upon monitoring results, audit results, or through communications with key commercial personnel and/or leadership.

Support other Compliance activity in North America (25% + of time)

  • Assist the North America Compliance Officer in supporting other compliance activities in another 'country'; business unit and/or EBI home office monitoring activities as needed.
  • Demonstrate Sanofi values and commitment to compliance on a consistent basis

Qualifications:
A minimum of a Bachelor's Degree from an accredited four-year college or university with a focus in Compliance; Finance/Audit, and/or Legal is required. Advanced Degree is preferred. A minimum of 10 years of professional work experience is required. A minimum of 2 years of professional work experience within a Sales and Marketing Pharmaceutical Compliance function is required. Fluency in Spanish and English (speaking and writing skills) are required. Auditing and monitoring experience in a pharmaceutical environment (Sales and Marketing) is preferred. Previous experience with partnering with cross-functional business teams: i.e. Legal, Regulatory, Medical, Commercial, and/or R&D, while maintaining strict compliance with company policies and procedures is required. Previous experience within a formal advisory position to senior Leadership Team members is preferred. Selected candidate will possess the following ket area of competencies: Track record of establishing a trusted business partner relationship; Significant knowledge and understanding of pharmaceutical compliance (Sales and Marketing) environment and requirements, including the Food, Drug, and Cosmetics Act, the False Claims Act, state and federal Anti-Kickback Statutes and the Foreign Corrupt Practices Act; Proficient computer skills, including experience with MS programs is required; data mining skills are highly desirable; Project management experience and/or skills is preferred. This position may require up to 20% overall travel (Domestic and International).

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

 Apply here
Posted 8/17/2018

ASSOCIATE DIRECTOR, COMPLIANCE - Avanir Pharmaceuticals
DEPARTMENT/FUNCTION: Compliance
LEVEL: 10
FLSA: Exempt


POSITION SUMMARY
The Associate Director Compliance, assists the Sr. Vice President, 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;
  • Ensures the company's compliance with all applicable federal and state health care laws and regulations, and industry codes of conduct; and
  • Meets or exceeds the standards set forth in the U.S. Sentencing Guidelines and 2003 OIG Compliance Program Guidance for Pharmaceutical Manufacturers.

This position is primarily responsible for the development and implementation of compliance written standards and communications. As a member of a collaborative team, this position also will contribute to the development and implementation of other components of the compliance program.

ESSENTIAL JOB FUNCTIONS
This position may include, but not be limited to, the following tasks:

  • Develops, revises, updates and maintains 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.
  • Develops, implements, tracks and measures employee training on all compliance policies, applicable laws, regulations and industry developments impacting the company's health care compliance.
  • Develops and implements the compliance component of new employee orientation and initial sales training, collaborating with relevant other departments of the company to do so.
  • Develops and delivers compliance training at company and departmental meetings, including the national sales meeting and sales managers meetings.
  • Develops, maintains and publicizes the Compliance department's internal compliance SharePoint page.
  • Partner with key stakeholders in Sales, Marketing and Medical Affairs (including management) to address questions and issues, and to implement compliance work plans.
  • Assists the CCO in preparing the annual compliance work plan based upon a comprehensive, annual compliance risk assessment of relevant functional areas of the company.
  • Assists the CCO in preparing reports to the Compliance Committee of the Board of Directors and otherwise executing the responsibilities of the Compliance Committee and CCO set forth in the Compliance Committee Charter.
  • Assists the CCO in developing and executing the agenda, meetings and responsibilities of the company's Compliance Committee.
  • 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.
  • Other responsibilities and duties as may be assigned.

QUALIFICATIONS
The person performing in this position is expected to possess the following qualifications:

  • 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, approximately 5% of working time.

EDUCATION and EXPERIENCE

  • Bachelors degree required. Advanced degree, e.g. J.D., Masters, PhD, etc., a plus.
  • Minimum of five (5) years experience in the pharmaceutical industry and five (5) years experience in a pharmaceutical manufacturing health care compliance program
  • Experience working with corporate integrity agreements highly preferred

The above is intended to describe the general content and to identify essential functions and requirements for performing this job, and it is not an exhaustive statement of duties, responsibilities or requirements. Avanir Pharmaceuticals, Inc. complies with the ADAAA and considers reasonable accommodation measures that may be necessary for eligible applicants/employees to perform essential job functions. Employment with Avanir is "at-will," meaning that either Avanir or an employee may terminate the employment relationship at any time, with or without cause, notice, reason or justification.

 Apply here
Posted 8/13/2018

DIRECTOR/SENIOR DIRECTOR, COMPLIANCE - Avanir Pharmaceuticals
DEPARTMENT/FUNCTION: Compliance
REPORTS TO: Chief Compliance Officer
LEVEL: 10
FLSA: Exempt


POSITION SUMMARY
The Director Compliance, assists the Senior Vice President, 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 applicable regulatory guidance for compliance programs, including the standards within the OIG Guidelines for an Effective Compliance Program, Department of Justice guidance, and the U.S. Federal Sentencing Guidelines
  • 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, experience and knowledge to support all elements of a state of the art pharmaceutical Corporate Compliance Program.

ESSENTIAL JOB FUNCTIONS
Manages elements of the Avanir Compliance Program, including but not limited to:

  • Managing the company's compliance infrastructure and oversight controls and mechanisms
  • Overseeing the company's internal and external compliance monitoring and auditing, including external reporting as necessary
  • Developing and delivering compliance training at company and departmental meetings
  • Assisting the CCO in preparing and presenting reports and dashboards to the Compliance Committee and the Board of Directors 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 compliance program.
  • Assisting the CCO in preparing the annual compliance work plan based upon a comprehensive, annual compliance risk assessment of relevant functional areas of the company.
  • 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.
  • Managing team members and projects to ensure inter and intra department coordination
  • Other responsibilities and duties as may be assigned.

QUALIFICATIONS
The person performing in this position is expected to possess the following qualifications:

  • Strong ethics and integrity
  • Ability to work independently with no routine supervision.
  • Demonstrated ability to exercise independent judgment with significant knowledge of the pharmaceutical industry and the regulatory enforcement environment
  • 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
  • Ability to manage people and third party vendors effectively
  • Ability to manage budgets effectively
  • Ability to manage complex cross functional initiatives

EDUCATION & EXPERIENCE - Bachelors degree required. Advanced degree, e.g. J.D., Masters, PhD, etc., a plus.

  • Minimum of ten (10) years' compliance experience in the pharmaceutical or device industry.
  • Significant experience managing compliance within the context of a Corporate Integrity Agreement highly desirable
  • 3+ Years Experience in people management
  • 3+ Years Experience in managing budgets

The above is intended to describe the general content and to identify essential functions and requirements for performing this job, and it is not an exhaustive statement of duties, responsibilities or requirements. Avanir Pharmaceuticals, Inc. complies with the ADAAA and considers reasonable accommodation measures that may be necessary for eligible applicants/employees to perform essential job functions. Employment with Avanir is "at-will," meaning that either Avanir or an employee may terminate the employment relationship at any time, with or without cause, notice, reason or justification.

 Apply here
Posted 8/13/2018

ETHICS AND COMPLIANCE MANAGER NA - Ipsen


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

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

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

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

ESSENTIAL FUNCTIONS

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

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

QUALIFICATIONS

Education and experience

  • Bachelor's degree in related discipline
  • Advanced degree preferred - JD or Graduate
  • 3+ years Pharmaceutical industry experience required
  • A history that shows an increase in responsibility and complexity (progression in responsibility and level)
  • 2-4 years of Compliance experience

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

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

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

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

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

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

 Apply here
Posted 8/10/2018

ETHICS AND COMPLIANCE SPECIALIST NA - Ipsen


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

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

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

Position Summary
The position will take significant responsibility in Ipsen's NA Ethics & Compliance Program by supporting various Compliance initiatives and the overall function of the department. This position requires a well-organized, highly detailed, self-motivated individual with excellent oral & written communication skills. The role will involve working with NA and International colleagues on a wide variety of ethics, compliance and administrative matters.

ESSENTIAL FUNCTIONS

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

  • Manage the Ethics & Compliance Budget including creating new vendors in the financial system, opening POs, routing invoices and balancing the budget
  • Support the Ipsen Transparency Program and systems by coordinating collection efforts, entering data into the aggregate spend system, auditing data and running reports
  • Manage the Compliance Curriculum in the Ipsen Learning Management System (LMS) by assigning training, running completion reports, and following up with incomplete training items
  • Provide general administrative support to the Ethics & Compliance Department including meeting planning, travel coordination and expense reporting
  • Aid in the Ethics & Compliance budget development and oversight including monthly tracking.
  • Coordinate the Policy Committee activities and organize policies throughout development and the policy lifecycle
  • Assist in monitoring activities, as needed
  • Provide project-level support and vendor management as needed

QUALIFICATIONS

Education and experience

  • Bachelors required
  • 2+ years of pharmaceutical industry
  • Experience working with vendors and getting results and reports from outsourcing partners
  • Experience working in Healthcare Compliance preferred
  • Experience with learning management systems preferred
  • Experience with aggregate spend systems and reporting highly favored

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

  • Excellent verbal and written communication skills
  • Work independently
  • Strong presentation and public speaking skills
  • Ability to manage projects, risks, cost, and time
  • Work effectively with team members to achieve company goals in effective ways
  • Strong planning and organizational skills and techniques
  • Communicate effectively with different functions
  • Good negotiating skills
  • Build strong relationships, understand organizational complexities and manage conflict
  • Work entails typical physical demands involved in office work

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

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

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

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

 Apply here
Posted 8/10/2018

SR. DIRECTOR ETHICS & COMPLIANCE US - Ipsen


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

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

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

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

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

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

ESSENTIAL FUNCTIONS

Responsibilities:

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

Travel: Approximately 25% domestic and international

QUALIFICATIONS

Education and experience

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

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

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

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

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

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

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

 Apply here
Posted 8/10/2018

DIRECTOR/COMPLIANCE COUNSEL - Heron Therapeutics


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

ESSENTIAL DUTIES & RESPONSIBILITIES:

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

REQUIREMENTS:

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

EOE

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

 Apply here
Posted 7/13/2018