Associate Director Regulatory Affairs Labeling (R1092010) in Reading, UK at IQVIA™

Date Posted: 10/9/2019

Job Snapshot

  • Employee Type:
  • Location:
    Reading, UK
  • Experience:
    Not Specified
  • Date Posted:
  • Job ID:

Job Description

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

Required knowledge, skills and abilities

  • Subject Matter Expert in pharmaceutical product labelling
  • Ability to provide strategic input to develop technology-enabled labelling services
  • Ability to provide strategic input to expand GRA labelling capabilities
  • Ability to provide strategic input based on planned and draft regulatory changes related to labelling (e.g. move to electronic Product Information)
  • Proven expertise in global labelling processes (including European Centralised, Mutual Recognition and Decentralised Procedure requirements for MAAs and variations) from initial change request through to implementation in the local market
  • Proven expertise in global labelling outputs, including Company Core Data Sheets (CCDS), justification document, Reference Safety Information (RSI), basis and reference labels, core and local labelling including artwork
  • Proven expertise in CTD Module 1 Product Information and Module 2.5 (clinical overview addendum)
  • Proven expertise and experience in chairing Global Labelling Committee meetings for the review of CCDS and RSI
  • Good understanding of US labelling requirements, including SPL format
  • Good understanding of process for preparation of initial CCDS from clinical trial data and Target product profile
  • Good understanding of pharmacovigilance activities related to Reference Safety Information for marketed products
  • Proven expertise for regulatory review of promotional material (AdPromo) for local market
  • Prepare and provide labelling training, including AdPromo for both regulatory and medical reviewers
  • Preferably, experience in labelling technology systems e.g. ZINC for AdPromo review and approval, RIM system with Labelling Module

Minimum required education and experience

  • Degree in life science-related discipline or professional equivalent plus at least 8 years regulatory experience, including 6 years labelling experience (or similar skill set)

Soft skills

  • Self-motivated individual
  • Excellent communication skills (verbally, written and providing clear progress updates)
  • Open and communicative personality
  • Ability to drive a programme of work
  • Be able to manage peaks of workload and prioritise workload with minimal supervision for self and assigned project team members
  • Ability to work to tight timelines
  • Good team player
  • Good negotiating skills
  • Be able to identify and resolve issues, using flexible adaptable approach
  • Strong computer skills, including MS Office applications, data and document management systems
  • Adaptable to change

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.

Job ID: R1092010