Senior Director, Ethics & Compliance US

Location
Cambridge, MA, United States
Posted
Aug 10, 2018
Ref
R-00541
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Title:
Senior Director, Ethics & Compliance US

Company:
Ipsen Biopharmaceuticals Inc.

Job Description:

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
  • Bachelor Degree required
  • MBA, JD, or professional degree is preferred
  • Minimum of 7-10 years of healthcare compliance experience

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.

IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.