Sr. Non-Compliance REMS Analyst

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Updated: November 1, 2021
Location: Somerset, NJ, United States
Job ID: 137223


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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 Syneos Health where we surround ourselves with the most talented and agile professionals in the industry, but we check our egos at the door.

 

Responsibilities

This opportunity is with our Deployment 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. More specifically:

The Syneos Health Senior Non-Compliance REMS Analyst will support multiple Engagement Center REMS programs by investigating potential non-compliance of REMS program guidelines, interacting with and advising key internal and external stakeholders, verifying completion of non-compliance response plans, tracking timelines for key metrics and writing reports and entering key data to document the lifecycle of non-compliance events.  The Senior Non-Compliance REMS Analyst will play an integral role in the escalation, communication, and investigation of any reported Non-Compliance identified by the REMS Engagement Center.

JOB RESPONSIBILITIES

Key job responsibilities include:

  • Supporting the Engagement Center REMS program to help ensure their FDA mandated objectives are met.
  • Conducts internal investigations of alleged non-compliance within REMS programs.  
  • Manages and is responsible for ensuring prompt, thorough, confidential and objective investigations in accordance with Company expectations, policies and protocols.
  • Engages in fact-finding activities, including but not limited to, assessment of allegations, collection and review of relevant documents, witness interviews and written summaries of same, analysis of facts and preparation of investigation reports within specified timeframes.
  • Collaborates with peers and business partners and assists in maintaining relationships to improve and implement solutions and service delivery.
  • Coordination and completion of government, regulatory, and compliance documentation for REMS programs.
  • Engages in REMS program auditing and/or monitoring activities.
  • Coordinates corrective actions with stakeholders and follows through to ensure they are implemented in a timely manner.
  • Provides timely reports, both orally and in writing regarding the status of non-compliance events.  Collaborates with Commercial Compliance and Ethics and business partners.
  • Performs other projects and duties as assigned.

 

Job Requirements

Along with demonstrated initiative, uncompromised integrity and a results-oriented mindset, the ideal candidate has:

Required Education:

  • BA/BS Degree or 3-5 years in a healthcare related field and relevant work experience in a compliance role with a company, preferably in the healthcare (bio/pharma/med device) industry

Required Skills/Abilities:

  • Experience working with PHI and PII required    
  • Experience with learning Tracking and Documentation CRM systems
  • Demonstrate current working knowledge of various rules, regulations and industry guidance relevant to healthcare compliance.
  • Excellent analytical, problem-solving and organizational skills required
  • A certain degree of creativity and latitude is required
  • 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 work independently and use good judgment while also collaborating frequently with team members from legal and compliance, human resources, other business units, and external stakeholders.
  • Ability to maintain confidentiality involving compliance and company information and activities.
  • Proficient in Microsoft Word, Excel, PowerPoint, Outlook or similar electronic mail program. 
  • Proficient with investigation databases and case management systems and tools
  • The drive for self-development, the ability to collaborate, and an action-oriented work ethic
As a healthcare company we have an important responsibility to protect individual and public health. This position will require individuals to be fully vaccinated against COVID-19 as part of their job responsibilities, unless an exemption can be confirmed based on a medical condition or sincerely held religious belief. Submission & Approval of an Exemption does not guarantee that an exemption can be accommodated.

At Syneos 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.

Why Syneos Health? Join a game-changing global company that is reinventing the way therapies are developed and commercialized. Here, you’re essential in solving and executing against today’s toughest commercialization challenges facing the world’s leading healthcare companies. From the very beginning, you’ll be supported by team members who, like you, aren’t afraid to try something new. You'll gain exposure and work in a dynamic environment to create better, smarter, faster ways to get biopharmaceutical therapies to patients.



WORK HERE MATTERS EVERYWHERE | How will you accelerate biopharmaceutical commercialization?

Syneos Health companies are affirmative action/equal opportunity employers (Minorities/Females/Veterans/Disabled)


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