19 days old

Regulatory Compliance Specialist

Kelly Services
Horsham, PA 19044
**Kelly Services** is currently seeking a **Lead Compliance Investigator** in **Horsham, Pa** to work a contract assignment **12 month duration** for one of our top clients. Kelly is a full service workforce solutions provider to 98% of the Fortune 100 companies. We provide employment to more than 700,000 people annually and we deal with some of the largest and best companies both nationally and locally.

**Primary Responsibilities includes:**

The Lead, Compliance Investigator is responsible for ensuring accuracy and consistency of compliance investigations, investigation categorizations and corrections / corrective actions taken related to late Individual Case Safety Reports, Late Aggregate Reports and any other compliance investigations performed by the Compliance Operations team and/or preliminary investigations performed by vendors. This role acts as the Subject Matter Expert for investigations and is responsible for handling day to day issues and answering process questions from Compliance Investigators and/or Vendor Resources. He/she manages complex investigations related to Vendors and Alliance Partners.


+ Performs investigations of complex compliance issues related to Vendors and Alliance Partners and other complex investigations as needed. Provides input into corrective/preventative actions and effectiveness measures for late ICSR and AR CAPAs and other compliance related CAPAs as appropriate.

+ Reviews compliance documentation, including categorizations, corrections, corrective actions and deviation memos for accuracy and consistency.

+ Handles day to day process issues and queries from Compliance Investigators and Vendor resources per documented procedures.

+ Participates in and/or leads compliance initiatives within internal stakeholders.

+ As Subject Matter Expert, creates compliance presentations and presents compliance data in various forums to all levels of management.

+ Under direction of Alliance Partner Process manager, may develop training and guidance documents for resources and vendors performing compliance investigations

+ Other duties as assigned.


Minimum of Bachelors Degree in relevant discipline (Business, Science, Medical, Operations, etc.) with 6 years of pharmaceutical industry experience or advanced academic degree with 4 years of pharmaceutical industry experience.

Minimum of 4 years of experience in pharmacovigilance case processing and/or PV compliance monitoring.

Understanding of GxP requirements.

Global pharmacovigilance experience required with knowledge of global PV laws and regulations.

Ability to function in a global matrix environment.

Excellent communication and writing skills. Ability to influence without authority.

Ability to lead global workstreams, drive teams to make decisions, achieve deliverables and manage and resolve issues independently.

Proven experience developing and conducting presentations for different levels of management; ability to tailor presentations to the appropriate level of detail.


**For immediate consideration, please send your resume in a WORD document to**

**Why Kelly** **** **?**

As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.

**About Kelly** ****

At **Kelly** , were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

Posted: 2020-05-08 Expires: 2020-06-08

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Regulatory Compliance Specialist

Kelly Services
Horsham, PA 19044

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