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Manager, Ethics & Compliance NA

Employer
Ipsen Biopharmaceuticals, Inc.
Location
Cambridge, MA, United States
Start date
Dec 16, 2018

View more

Discipline
Regulatory, Legal/Compliance
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Genetown

Job Details

Title:
Manager, Ethics & Compliance NA

Company:
Ipsen Biopharmaceuticals Inc.

Job Description:

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
  • Bachelor's degree in related discipline
  • Advanced degree preferred - JD or Graduate


Experience
  • 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.

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.

Company

Ipsen (Euronext: IPN; ADR: IPSEY) is a global, biopharmaceutical group focused on innovation and specialty care. The group develops and commercializes innovative medicines in three key therapeutic areas - Oncology, Neuroscience and Rare Diseases. At Ipsen, we focus our resources, investments and energy on discovering, developing and commercializing new therapeutic options to provide hope for patients whose lives are challenged by difficult-to-treat diseases. Ipsen's North American operations and headquarters are located in Cambridge, Massachusetts, where our fully integrated biopharmaceutical team across External Innovation and Partnering, Research & Development (R&D), Manufacturing and Commercial collaborate. Cambridge is home to Ipsen's third global hub, in addition to R&D centers in Paris-Saclay in France and Oxford in the United Kingdom. With additional offices in Basking Ridge, N.J. and Mississauga, Ontario, Ipsen employs approximately 600 people in North America. For more information on Ipsen in North America, please visit www.ipsenus.com or www.ipsen.ca.

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Company info
Website
Phone
617-679-8500
Location
1 Main Street
Unit 700
Cambridge
MA
02142
United States

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