Posted to MedZilla on 2/17/2018

inVentiv Health

Compliance Operations Manager- Pharmaceutical 68474-MZ


City Somerset
State New Jersey [NJ]
Zip 08873
Date Open 1/24/2018
Title Compliance Operations Manager- Pharmaceutical
Job ID 68474
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 21,000 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.
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.
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 Medical Affairs and Commercial Compliance programs 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.
  • Prepares Compliance reports to present to management.

Medical Affairs (includes but not limited to MSL & Clinical Nurse Educators) and Field Sales (Client) Teams:

  • Conducts Commercial Compliance capabilities presentations for potential clients and kickoff meetings for new client teams.
  • Collaborates and interacts with Medical Affairs personnel in preparing and delivering training and guidance.
  • 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.
  • Collaborates with clients to develop and approve client-specific Healthcare Compliance Business Rules
  • Develop, review and approve Compliance Training and Modules
  • Creates applicable compliancse 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
  • Oversee and assign projects to Compliance Specialists
  • Manage compliance projects to meet departmental objectives;
  • Identify, develop and implement processes to improve Compliance oversight and monitoring efforts
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

Along with demonstrated initiative, uncompromised integrity and a results-oriented mindset, the ideal candidate has:
  • 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
  • Familiarity with working under a Corporate Integrity Agreement (CIA) preferred
  • 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.
Syneos 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 Syneos Health position

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