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City Burlington
State Massachusetts [MA]
Title Senior Compliance Manager
Job ID 43501
Overview
inVentiv Health offers best-in-class Clinical, Consulting and Commercial services to global companies seeking to accelerate performance. With 13,000 employees in 40 countries, we rapidly transform promising ideas into commercial reality. inVentiv has committed itself to hiring and retaining the very best talent in the healthcare industry, those who have a single common characteristic: the desire and aptitude to succeed. We are focused on hiring the best, those who possess unparalleled knowledge and experience as well as a passion for delivering exceptional ideas and service to our clients. In turn, inVentiv provides an opportunity-rich environment where employees can grow as professionals in one of many disciplines and pursue long-term career goals throughout our worldwide network of locations.
 
Responsibilities  
    
The Senior Manager, Compliance will report to inVentiv’s Associate General Counsel and Chief Compliance Officer and be based out of our headquarters in Burlington, MA or in Somerset, NJ. 
 
Purpose/Role Statement
Provide key support role for inVentiv’s global Compliance Program. Support creation and implementation of policies, procedures, processes and SOPs to maintain an effective Compliance Program. Drive training and communications. Develop, manage systems and databases. Handle day to day operations. Manage external vendors; negotiate vendor contracts. Support investigations, governance and clients’ compliance requirements.   Assess business issues and recommend solutions and process improvements.
 
Key Responsibilities
  • Support creation of and implement, maintain and train on procedures, processes and SOPs to facilitate a robust and effective Compliance Program
  • Support development, implementation and administration of compliance policies
  • Assessing user needs, and working with vendors as appropriate, develop and maintain relevant systems and databases
  •  Manage day to day Compliance Program operations, including reporting, tracking, training, communications. Assess need for, recommend, develop, drive process improvements
  • Administratively support anonymous help line; develop metrics, tracking, reporting system
  • Support compliance investigations, assess, implement remedies
  • Support development of metrics to measure Compliance Program effectiveness; maintain and report on metrics
  • Working with cross-functional internal partners, such as HR, Training, Legal and IT, and with external vendors as needed, support development and implementation of effective training and communications program. Manage all related tracking, reminders, client reporting, etc.
  • Manage external compliance vendors; negotiate contracts
  • Provide day to day guidance related to Code of Business Conduct and Ethics
  • Provide compliance governance support
  • Support clients’ compliance requirements, including related to client Corporate Integrity Agreements
  • Effectively partner with other compliance resources, including Legal Department attorneys and staff, Quality, Privacy resources, and the company’s businesses, toward the development and maintenance of a comprehensive Compliance Program
  • Support compliance diligence efforts
  • Support development of risk management tools and tracking; support identification of risk gaps and solutions to address
  • Support Privacy Program
  • May engage in auditing and/or monitoring
  • Provide assistance on special projects and other duties as assigned
  • Act as Compliance role model and ambassador to create awareness and increase program effectiveness throughout the company
Requirements

   

  
Qualifications :
 
Bachelor’s Degree, preferably a Masters, JD or other advanced degree; compliance credentials a plus
 
At least seven years of compliance experience, at least three of which have been with a global, regulated company, preferably in the healthcare (bio/pharma/med device) industry
 
Experience with:
  • Broad-based compliance program support
  • Development, implementation and maintenance (including systems maintenance) of compliance training programs; design development a plus
  • Compliance communications
  • Policy development and implementation
  • Business process improvements/project management
  • Database management
  • Interaction with regulators/agencies
  • Interaction with senior management
  • Managing external vendors; contract negotiation
  • Risk assessment; investigations; development and implementation of corrective actions
  • Legal, quality, privacy experience a plus
 
 

Benefits: At inVentiv Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality of life balance.

 

inVentiv Health & its Clients are equal opportunity employers and are committed to employing a diverse workforce.

 

Minimum Education Level Professional
Employment/Job Type Full Time
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