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Compliance Operations Manager- Pharmaceutical

Updated: December 12, 2017
Location: Somerset, NJ, United States
Job ID: 67541
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Overview
You're driven, resourceful, and above all else - remarkably smart.
 
You love a good challenge. You are the first to roll up your sleeves and work with relentless energy until you solve the unsolvable, beat the unbeatable and you always come out on top. Passable doesn't cut it - you've got fire in your belly to learn more, do more and be more. For you, the sweetest success is shared success and you're known for your good nature. You'll fit right in at INC Research/inVentiv Health where we surround ourselves with the most talented and agile professionals in the industry, but we check our egos at the door.
 
Why INC Research/inVentiv Health? Join our groundbreaking global network of more than 22,000 employees with the ability to service clients in over 110 countries. As part of the only fully integrated biopharmaceutical solutions organization, you'll be connected to a multitude of career paths and employment opportunities. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work with endless energy in a dynamic environment to over-deliver and outperform. You'll integrate seamlessly with our clients and do what's best for their success. In a recent five-year period, INC Research/inVentiv Health has helped to develop or commercialize 82% of novel new drugs approved by the FDA and 70% of products granted marketing authorization by the EMA.
 
Here, there's no shortage of challenging work, learning and opportunities. Because we offer many services to varied clients, our knowledgeable professionals gain experience across a large section of the industry. Our client roster consists of more than 550 organizations including all 50 of the largest global biopharmaceutical companies.

Responsibilities
This opportunity is with our Selling Solutions team, which partners with top tier pharmaceutical, medical device and biotechnology companies to provide better, smarter, faster solutions for the industry. Take part in leading the transformation of healthcare by joining the largest provider of outsourced commercial solutions to the healthcare industry. The Manager of Compliance Operations will report to the Senior Director of Commercial Compliance and is responsible for the development, implementation and management of the Commercial Compliance program for clients and department-wide operations. More specifically: 
 
  • Manages and implements programs, policies, and practices to ensure that all departments are in compliance with HIPAA and accreditation standards
  • Designs and implements programs, policies, and practices to ensure that all business units are in compliance with federal, state, and local regulatory requirements
  • Tracks and documents laws and regulations that might affect the organization's policies and procedures
  • Prepares Compliance reports to present to management
  • Responsible for the direct management and professional development of the Compliance and Senior Compliance Operations Specialist(s)
 
Field Sales (Client) Team:
 
  • Conducts Commercial Compliance capabilities presentations for potential clients and kickoff meetings for new client teams
  • Provides leadership and management for all compliance activities in support of client teams
  • Ensures client team activities are in compliance with company policies and industry standards
  • Delegates team lead for clients
  • Approves client-specific Healthcare Compliance Business Rules
  • Approves Compliance Training and Modules
  • Creates applicable compliance SOPs and policies in collaboration with internal departments to ensure compliance to applicable healthcare laws, rules, regulations and client business rules
  • Deliver live training at Client/project launches
  • Approve Client Compliance training materials as well as Selling Solutions Compliance trainings
 
Department Projects:
 
  • Lead and direct Selling Solutions employees/departments on Healthcare Compliance-related matters
  • Assign projects to Specialists and direct reports
  • Manage departmental projects to meet departmental objectives
  • Assist Senior Director of Commercial Compliance to assess risk mitigation strategies in partnership with the business
  • Identify, develop and implement processes to improve Compliance oversight and monitoring efforts
 
Investigations and Direct Marketing Expense (DME) Audit
 
  • Review reported matters to determine if alleged incident requires formal investigation and forward to Lead Investigation Specialist as deemed necessary
  • Oversees investigation from initiation to closure within appropriate timeline; Leads investigation interviews
  • Develops and implements corrective actions in partnership with Human Resources counterpart
  • Assigns Client teams to Auditing Specialists
  • Develops and approves Client Audit Plan
 

Requirements
Along with demonstrated initiative, uncompromised integrity and a results-oriented mindset, the ideal candidate has:
 
  • BA/BS Degree
  • In lieu of Bachelor's degree must have a minimum of 7 years related experience
 
Required Skills/Abilities:      
  • Demonstrate current working knowledge of various rules, regulations and industry guidance relevant to healthcare compliance
  • Familiarity with components of compliance programs; specific experience in training, communications and/or business process development
  • Possess strong interpersonal skills with the ability to interact upwardly and downwardly in the organization
  • Ability to forge strong working relationships with employees in different disciplines and at all levels of the organization
  • Possess strong communication writing, analytical and organizational skills
  • Demonstrate high standards of conduct and ethics as well as appropriate judgment, independence, and discretion
  • Ability to maintain confidentiality involving compliance and company information and activities
  • Familiar with a variety of the field's concepts, practices, and procedures.
  • Relies on extensive experience and judgment to plan and accomplish goals.
  • The drive for self-development, the ability to collaborate, and an action-oriented work ethic
 
Full INC Research/inVentiv Health benefits which include:
  • Competitive compensation and bonus
  • Generous paid time off and company paid holidays
  • Comprehensive medical, dental, and vision package
  • Matching 401K
  • Dedicated training and support
  • Tuition reimbursement
  • Referral bonuses and other personalized quality of life conveniences
 
Make your work matter everywhere. Be a driving force in a rapidly evolving healthcare industry.
 
INC Research/inVentiv Health is an affirmative action/equal opportunity employer (Minorities/Females/Vet/Disabled)  

Years Exp
8-10

Position Type/Category
Compliance

Minimum Education Level
Bachelor's Degree

Employment/Job Type
Full Time

Employment Type
INC Research/inVentiv Health position

“INC Research/inVentiv Health is a place where I can get things done, ensure my client is successful and make a difference for patients.