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2017-43581

2017-43581

Title 
Regulatory Information Manager - Deerfield, IL
Job Locations 
-
US-IL-Chicago
Posted Date 
12/8/2017

More information about this job

Overview

Do you want to watch clinical development change, or be the one to shape it?

 

We’re hoping you’re here for the latter.

 

Who are we?

We Are PRA.

 

We are 13,000+ employees strong, operating in more than 85 countries. We are committed to saving lives and  constantly striving to be the best at what we do. Our impact is real and we see it every single day. We are getting life-saving drugs into the hands those who need them most.

 

Who are you?

You are a forward thinker. You are an innovator who refuses to settle. You want to push the boundaries and change not just what it means to be an Information Manager, but also the future.  You want to learn from the best, grow your knowledge and your skill set, and you want to build your career here. You want to use the latest technology and tools in the industry to push forward the momentum of an already growing company. You want to find a balance that still lets you be, well, you. Most of all, you want to do it at a place where you’re more than an employee number, a place you love to work at.

 

Still here? Good. Because if this is you, we’d really like to meet you.

Responsibilities

What will you be doing?
As an Information Manager, you will ensure that data stored and maintained in the Global Regulatory Affairs (GRA) Regulatory Information Management (RIM) environment is current, accurate, reliable, and generally fit for purpose at any given point in time. The function secures the integrity of data that is used internally for business intelligence / reporting purposes, and externally to comply with global Regulatory agency information requests and obligations. This function acts as the custodian of GRA’s information management landscape, and will input to / align with Global Master Data Management strategies, as appropriate.

 

  • Focus on enabling delivery of one or more service lines offered by the Information Management team. Examples of such service lines are:

 -Business intelligence and compliance reporting.
 -Data provision and submission to external databases such as eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) and ISO Identification of Medicinal Products database (IDMP).
 -Data quality management and remediation.
 -Coordination of data entry work undertaken by Information Analysts.

  • Will be Subject Matter Expert in one or more of the service lines that are offered by the function.
  • Information Managers are likely to have direct line management responsibility and / or may be required to supervise contingency workers.
  • Daily management / oversight of local staff and professional development of IM staff at the site ensuring alignment with the core competencies of the RIM role(s). Responsible for setting goals and measuring performance against such goals and expectations through the effective use of company performance management tools and processes.
  • As an expert in the field of Regulatory Information Management, manages (Snr) Information Analysts to ensure that data is entered and verified in the company’s RIM system(s) and submitted to external agency databases (i.e. XEVMPD, ISO IDMP, etc.). 
  • Has overall accountability for ensuring data is maintained in compliance with company / agency processes and standards and that data errors are effectively remediated.
  • Accountable for any response activity generated as a result of making submissions to external agency databases (i.e. XEVMPD, ISO IDMP, etc.); ensures that all such responses are satisfactorily closed-out with the relevant Regulatory authorities.
  • In collaboration with key customers, will define, create, and validate business intelligence reports to support Regulatory strategies and drive internal / external compliance activities.
  • Manages the team to continuously review support requests to identify recurring issues and trends; facilitates the identification of business process / system change and makes recommendations to line management accordingly.
  • Builds strategic partnerships with information providers / key stakeholders across the company to ensure Regulatory Information is managed in an effective and compliant manner.
  • Accountable for ensuring that system dictionaries / code lists are aligned to the appropriate company / industry / agency standard(s).
  • Creates and delivers educational offerings (training materials, quick reference guides, newsletter, etc.) to support accurate, timely and reliable management of Regulatory information both internally and externally.
  • Provides input to initiatives and systems projects to ensure that evolving Information Management requirements are understood and implemented (where appropriate).
  • As needed, supports and facilitates the creation, review and administration of departmental / company business process documentation.
  • Is an SME in areas such as IDMP, XEVMPD, business intelligence reporting or Regulatory information quality management.
  • Maintains an expert, current knowledge of regulations, legislation, best practices and guidelines relating to RIM (i.e. GxP, Annex 11, 21 CFR Part 11, ISO standards, etc.).
  • Represents the company at relevant industry forums.

Qualifications

What do you need to have?

 

          Education: 

  • First degree in Information Management, Life Sciences, Computer Science or similar; these requirements can be waived for exceptional candidates who can demonstrate substantial, relevant work experience over a sustained period (minimum 5 years).

          Experience

  • 5+ years’ experience of working in a Global Regulatory Affairs function demonstrating an awareness of global Regulatory authority procedures.
  • Experience of managing 1 – 3 members of staff (FTE or contractor).
  • Demonstrable experience of Regulatory information quality management / implementation of data standards in a RIM context.

         Knowledge and Skills:

 

         Systems / RIM Knowledge

  • Demonstrated experience of using and administrating RIM systems.
  • Extensive experience of managing Regulatory Information in controlled Regulatory Information Management systems to defined quality standards. Extensive experience of working with external pharmaceutical data standards (pharmacopeia, standard terms, ISO, MedDRA, EDQM etc).
  • Extensive experience of interrogating information held in RIM systems, developing validated reports and managing complex query definition in response to customer requests.

         Regulatory Familiarity:

  • Strong background in Global Regulatory Affairs as well as understanding of European, U.S., and international regulations relative to RIM.

         Industry Knowledge:

  • Sound awareness of industry trends and benchmarks as they pertain to RIM.
  • In-depth understanding of operating philosophy, structure and ways of working including a thorough knowledge of the local operating company network and relationships with affiliates / partners.

         Analytical Skills:

  • Able to efficiently determine the root cause of a problem, identify viable, risk-balanced solutions and implement such solutions appropriately.


PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

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