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Compliance Operations Specialist - Pharmaceutical

Updated: December 12, 2017
Location: Somerset, NJ, United States
Job ID: 67540
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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 Compliance Operations Specialist will report to the Sr. Compliance Manager and provides assistance on client activities, interacts with internal departments, fielding issues and functions as secondary contact for routine Compliance matters. More specifically:

  • Supporting the Commercial Compliance Department to help ensure the objectives are met
  • Assist in the coordination and completion of government, regulatory, and compliance documents for field sales teams in Selling Solutions
  • Provides monitoring for Compliance Training completion - Live and Learning Management System
  • Performs a variety of tasks in support of the Commercial Compliance department as required.to include:

Client Teams:
  • Assists manager in launch of client teams
  • Creation of Compliance Business Rules Documents
  • Create Training and Business Rules Modules
  • Participate in Weekly Workstream status meetings (internal) and assist in updating Workstream slides
  • Business Meals Guide and Roster
  • Assist with Vendor Credentialing
  • D.C. licensing
  • Acts as Project Assistant for department projects

Investigations and Direct Marketing Expense (DME) Auditing
  • Create File: Form, log, folder
  • Schedule investigation interviews
  • Background investigation and information gathering; Note taker, as needed
  • Maintains Investigation Log
  • Review emails from Auditors
  • Escalates potential Compliance investigations to management
  • Updates Master Guidelines
  • Provides communication with Field/Operations Management


Requirements
Along with demonstrated initiative, uncompromised integrity and a results-oriented mindset, the ideal candidate has:
 
BA/BS Degree or 3 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
  • Excellent knowledge of MS Word, Excel, PowerPoint
  • Relies on experience and judgment to plan and accomplish goals
  • A certain degree of creativity and latitude is required
  • 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)  

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.