Compliance Operations Manager - Pharmaceutical

Updated: December 14, 2018
Location: Somerset, NJ, United States
Job ID: 2320

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 Syneos Health where we surround ourselves with the most talented and agile professionals in the industry, but we check our egos at the door.
 
Why Syneos Health? Join a game-changing global company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies - INC Research and inVentiv Health - we bring together more than 23,000 clinical and commercial minds to create better, smarter, faster ways to get biopharmaceutical therapies to patients. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment where you'll be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. Grow your career with a global company committed to shortening the distance from lab to life.

Responsibilities

The Manager of Compliance Operations will report to the Director of Commercial Compliance and is responsible for the development, implementation and management of Commercial Compliance programs for clients and department-wide operations.   More specifically:

Job Responsibilities:

  • Manages the day to day compliance program operations across multiple contracted commercial field teams and internal departments to ensure adherence to federal, state and local regulatory requirements and company policies.
  • Creates applicable SOPs, work instructions, training, and other documents related to the compliance program; this may involve any or all of the seven elements of an effective compliance program.
  • Identifies, develops and implements processes to improve compliance oversight and monitoring efforts.
  • Develops and delivers training programs regarding compliance-related regulatory requirements for contracted commercial field teams.
  • Initiates, facilitates, and promotes activities to foster compliance awareness and to encourage reporting of compliance issues within the organization and related entities.
  • Monitors for new developments in state and federal health care laws and regulations to ensure the compliance program is current on legal requirements.
  • Collaborates with clients to create and implement Compliance Business Rules and direct marketing expense audit plans for respective commercial field teams.
  • Partners effectively with business leaders to develop, implement, and monitor key compliance functions and risk areas for contracted commercial field teams.
  • Conducts Commercial Compliance Capabilities presentations for potential clients and kickoff meetings; lead compliance work streams and meet deliverables for launching new contracted commercial field teams. 
  • Delivers live training at client/project launches.
  • Provides guidance to Selling Solutions employees/departments and clients on Healthcare Compliance-related matter.
  • Leverages familiarity and understanding of PhRMA Code, OIG-DHHS seven elements of an effective compliance program, and the AdvaMed Code.
  • Maintains a fundamental understanding of compliance laws and regulations related to promotional activities.

Job Requirements

Along with demonstrated initiative, uncompromised integrity and a results-oriented mindset, the ideal candidate has:
  • BA/BS Degree and 5 years related experience
  • In lieu of Bachelor's degree must have a minimum of 8 years related experience
  • Demonstrate working knowledge of Federal, State and local regulatory requirements and industry standards relevant to healthcare compliance and promotional field activities.
  • Familiarity with components of compliance programs; specific experience in training, communications, monitoring and/or business process development.
  • Strong ability to prioritize, manage multiple commercial field teams and perform multiple projects concurrently.
  • Experience and ability to initiate, develop, maintain, and review policies and procedures for the operation of a healthcare compliance program and other similar activities to minimize unethical, illegal, or improper conduct.
  • Healthcare compliance evaluation and auditing/monitoring experience to be able to discover potential problems; recommend and execute strategies to mitigate risk. 
  • Strong communication, written, analytical and organizational skills to effectively assess and alleviate project risks and report progress to senior management, colleagues and clients.
  • Proven ability to collaborate and advice management and clients on compliance matters; ability to develop practical business solutions and to facilitate risk assessment.
  • 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.
Full Syneos Health benefits which include: 
  • Generous paid time off and company paid holidays
  • Domestic Partner Coverage for: medical, dental, vision, and voluntary life insurance
  • Medical – Cigna; Dental – Delta Dental; Vision - EyeMed
  • Company Match 401K - $0.50 per dollar up to 9% of salary
  • Eligible to participate in Employee Stock Purchase Plan
  • Flexible Spending Accounts: Health Care and Dependent Care
  • Company-paid Basic Term Life Insurance at 2x base salary
  • Optional Supplemental Term Life Insurance (100% employee paid): for employee, spouse/domestic partner, and children.
  • Company-paid Short and Long Term Disability
  • Optional Supplemental Short and Long Term Disability (100% employee paid): employee only
  • Employee Assistance Program
  • Referral bonuses
  • Dedicated training and support
Make your work matter everywhere. Be a driving force in a rapidly evolving healthcare industry.
 
Syneos Health companies are affirmative action/equal opportunity employers (Minorities/Females/Vets/Disabled)
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