Regulatory Information Analyst

  • InternetJobs.com
  • Deerfield, IL, USA
  • Sep 03, 2017

Job Description



Information Analyst Deerfield, IL





Kelly Services is currently seeking an experienced Information Analyst for a 6+ month contract role in Deerfield, IL.





This is a great opportunity to work for a company that among the top 15 pharmaceutical companies in the World!



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.
This position is recruited by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must submit your resume to [Click Here to Email Your Resum ]. Due to the high volume of responses anticipated, only qualified candidates will be contacted.
OBJECTIVES:
The Information Management team ensures that data stored and maintained in GRA s Regulatory Information Management (RIM) environment(s) 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 custodians of GRA s information management landscape and will input to / align with the companies global Master Data Management strategy/ies as appropriate.
Project Details:
Currently migrating data from a legacy system into our current regulatory tracking system. There will be loads of data analysis and population of spreadsheets.
Top 3 Qualities/Skills for someone that will be most successful in this role:




  • MUST know the regulatory landscape.
  • MUST be detail-oriented
  • MUST have top-notch communication skills.


The Information Analyst role is focused on 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.
  • Co-ordination of data entry work undertaken by Information Analysts.


Individuals fulfilling the role of Information Analyst are likely to be generalists looking to develop their skills and experience within the RIM landscape.
Information Analysts have no direct line management responsibility.
ACCOUNTABILITIES:




  • Proactively works with the GRA business to maintain and align system dictionaries / code lists to the appropriate company / industry / agency standard(s).
  • As a professional in the field of Regulatory Information Management collaborates with data owners to ensure that data is entered into the company s RIM system(s) in compliance with company / industry / agency standard(s).
  • Acts as a quality gate to ensure compliance with the company s Regulatory Information data standard is maintained at all times. Manages resolution of any resulting Quality Investigations or CAPAs with internal stakeholders / QA.
  • Prepares and ensures the submission of data and supporting documentation to external agency databases (i.e. XEVMPD, ISO IDMP) in compliance with agency requirements and standards. Actively contributes to responses to agency queries raised as a result of making these submissions.
  • Builds strong working relationships with information providers / verifiers (primarily) within GRA to encourage and support accurate, timely and reliable entry of Regulatory information into the company s RIM system(s).
  • Supports the RIM team in the interrogation of Regulatory Information to identify trends that can be presented in business intelligence reports to management.
  • Proactively monitors relevant agency guidelines / regulations that are noticed in the course of everyday business to ensure that potential impacts / new requirements are identified and managed at the optimum time.


EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
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 2 years).
1-3 years experience of working in a Global Regulatory Affairs function demonstrating an awareness of global Regulatory authority procedures.
Preferred:
Experience of working with data in RIM systems and of performing advanced queries in such systems.
Knowledge and Skills:




  • Systems / RIM Knowledge:
    • Some experience of using and administrating RIM systems.
    • Some experience of managing Regulatory Information in controlled Regulatory Information Management systems to defined quality standards. Extensive experience of working with external data standards (pharmacopeia, standard terms, ISO, MedDRA etc).





  • Regulatory Familiarity:
    • Some background in Global Regulatory Affairs as well as understanding of European, US and international regulations relative to RIM.





  • Industry Knowledge:
    • Some understanding of how the pharmaceutical industry works.
    • Some awareness of industry trends and benchmarks as they pertain to RIM.





  • Analytical Skills:
    • Able to efficiently determine the root cause of a problem, identify viable, risk-balanced solutions and implement such solutions appropriately.
    • Able to interrogate structured information to identify trends and issues; able to present findings / results in a concise and clear manner.





  • Communication Skills:
    • Able to express oneself clearly and concisely to audiences at all levels of the organization; documents issues and / or concerns concisely and comprehensively. Ability to work collaboratively and effectively with internal and external company functions to supply data or receiving information from the team.





  • Team Working:
    • Excellent team player with an affinity to culture strong relationships in a matrix / remote environment with colleagues at all levels of the organization.
    • Able to work effectively in cross-functional and cross-regional teams to achieve results in a matrix setting.





  • Knowledge Sharing:
    • Ability to capture knowledge within (and from outside) the organization; offer solutions, improve processes and deliverables through use of information; improves information capital by contributing experience, deliverables and models for others to use.





  • Interpersonal Flexibility:
    • Ability to adapt to other personalities in a respectful manner that is conducive to achieving team / company goals and objectives.




LICENSES/CERTIFICATIONS:




  • No essential licenses / certifications necessary.
  • Project management qualifications (i.e. PRINCE2) and ITIL are relevant.


TRAVEL REQUIREMENTS:




  • Willingness to travel to various business meetings / training courses including overnight trips. International travel may be required.
  • Requires approximately 5% travel.


Kelly Employee Perks:




  • Group medical, prescription, vision, dental, life, and short-term disability insurance options that are available for purchase and the coverage is portable*
  • Service bonus plan
  • Holiday pay plan
  • Weekly electronic pay options
  • Free online training campus available
  • Exclusive online employee community
  • Corporate discounts


Apply Now!





Why Kelly?

With Kelly, you ll have direct connections to leading IT organizations in the best companies around the globe offering you the chance to work on some of today s most intriguing, innovative and high-visibility projects. In a field where change is the only constant, our connections and opportunities will help you take your career exactly where you want to go. We work with 95 of the Fortune 100 companies, and more than 9,000 IT hiring managers turn to us each year to access the best talent: people like you.

Last year we found 10,000 opportunities for IT professionals. Let us help advance your career today.



AboutKelly Services

As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.



Associated topics: chief program officer, cpo, manage, manager, management, monitor, product manager, project manager, relationship manager, task

Company

Kelly Services