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Regulatory Affairs Specialist (France, Home-Based) - IQVIA Biotech

Employer
IQVIA Biotech
Location
France
Salary
Competitive
Start date
20 May 2019
Closing date
19 Jun 2019

Job Details

Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

Here at IQVIA Biotech we have a vacancy within our Regulatory Team for an experienced Regulatory Affairs Specialist. This is a home based position in France working as part of a Global team. You must have clinical research regulatory experience ideally within a CRO environment. 

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

  • Assist Associate Director, Regulatory Affairs, in assuming primary or secondary regulatory responsibility for assigned clinical research projects by providing to the project team regulatory information, guidance, training, support and strategic planning based on applicable regulations and guidance issued by the applicable regulatory agency(ies).
  • Identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organizations.
  • Review protocols, consent forms, reports, scientific documents, publications, and related papers, etc., as appropriate for various clinical research projects to ensure compliance with regulations.
  • Ensure the compilation and maintenance of pertinent documentation (e.g., files) required for regulatory compliance for assigned clinical research projects. 
  • Serve as a member of groups, teams, or committees related to regulatory affairs, and quality assurance or other designated IQVIA Biotech activities, as appropriate.
  • Serve as IQVIA Biotech liaison with central IRBs.
  • Perform other related duties as assigned.

KNOWLEDGE, SKILLS AND ABILITIES:

  • Working knowledge of and aptitude for activities related to regulatory affairs and quality assurance, both domestic and international.
  • Familiarity with or ability to become familiar with regulatory documents, general contents, organization and the methods of filing and tracking.
  • Familiarity with or ability to become familiar with principles of Good Clinical Practice, Good Laboratory Practice and Good Manufacturing Practice., ISO standards.
  • Extensive knowledge of clinical research; knowledge and familiarity with 21CFR11 and EDC systems.
  • Experience in preparation of audit plans and checklists against applicable standards, execution of audits, and preparation of comprehensive written audit reports.
  • Good interpersonal skills with the ability to communicate effectively, both orally and in writing, with all levels of staff, and with the public. 
  • Ability to be detail oriented with background adequate to deal with scientific issues related to technical regulations and SOPs.
  • Ability to read and synthesize technical material and to prepare clear and concise written documents.
  • Computer literate at a level allowing utilization of event tracking programs, data loading and information processing related to regulatory affairs and quality assurance.

CRITICAL JOB FUNCTIONS IN ACCORDANCE WIH ADA CRITERIA:

  • Ability to travel domestically
  • Very limited physical effort required to perform normal job duties

Please apply by following the link to our website. 

Please ensure your CV is submitted in English language.

Company

IQVIA Biotech is the global, enterprise-wide solution that provides flexible, tailored, integrated clinical and commercial solutions to small biotech and pharmaceutical companies, from planning through trial design and implementation to launch and commercialization.

We recognize that the needs of small companies are different than large companies, so we developed a separate business unit within IQVIA which provides a high-touch solution with high levels of service and hands-on attention, with the benefits of IQVIA’s data and expertise – including powerful analytics, resources, therapeutic experts and global footprint.

IQVIA Biotech has five therapeutic divisions. Complementing our successful history in Oncology, we have dedicated delivery teams in General Medicine – which includes Dermatology, Cardiovascular/Renal/Metabolics, Central Nervous System and Immunology.

Interested in being a part of this exciting and dynamic team?

Contact us today to find out more!

 

Company info
Website
Telephone
+44(0)1438 221122
Location
Ground Floor
Abel Smith House
Gunnells Wood Road
Stevenage
Herts
SG1 2ST
United Kingdom

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