Regulatory Affairs Manager (R1065832) in Reading, UK at IQVIA™

Date Posted: 9/15/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Reading, UK
  • Experience:
    Not Specified
  • Date Posted:
    9/15/2019
  • Job ID:
    R1065832

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.

Lead a broad cross-functional Core Transition team, comprised of functional representatives appropriate for the deal.  SUPPLIER PM will act as the Patient Safety (PS) Regulatory Affairs (RA) Workstream lead in the Core transition team. SUPPLIER PM will lead a team of key functional activity leads to provide management of transition activities to relevant Project Milestones, as well as core SUPPLIER delivery activities including but are not limited to: Green Light Process, Regulatory Activities, Pharmacovigilance (PV) Agreement and Document/Information Transfer. If key activity leads are not assigned, the PM will assume those duties until completion of that activity. SUPPLIER PM may interface with the equivalent External Deal Partner counterpart to agree joint dashboard reporting for the workstream, as well as agree approach/ways of working for the joint workstream team, status discussions, issue/risk discussions, etc.

If assigned or delegated by PVA lead, Supplier PM will be working with designated client´s Stakeholders managing the drafting and approval of the PV Agreement; interface with cross functional team of PVA Stakeholders that will be responsible to provide inputs and be accountable for content accuracy from a functional perspective;  interface with the External Deal counterpart equivalent PVA lead to agree approach, timeline plan, facilitate comments resolution, and jointly agree PVA sub-milestones for status and dashboard reporting.

Lead efforts for issue resolution and proper escalation as needed.

Specific activities may include but not limited to:

  • Prepare material for and lead Workstream Kick-Off meeting, dashboard maintenance
  • Attend core transition team meetings to provide RA PS status updates, issue reports, etc and to communicate relevant cross functional updates back to RA PS workstream team
  • Collect and collate workstream team ‘sub-lead’ sub-milestone dashboards on regular basis
  • Maintain overall PS RA workstream risk/issue/action log and follow up with workstream ‘sub-leads’ for appropriate applicable resolution
  • Coordinate and engage in stakeholder communication
  • Engage client Buddy in appropriate issue escalation
  • Provide guidance and direction to the Workstream team, as well as SUPPLIER delivery team including Green Light Lead, Regulatory Affairs team, Pharmacovigilance Agreement Lead, Information Transfer team and other team members assigned, and continue status reporting upon transition
  • Maintain all project documentation in ERA Box, including documentation to substantiate mutual acceptance of milestone status with external workstream lead counterpart
  • Be proactive in ensuring the successful completion of the PS and RA activities required for the asset transfer to the project milestone plan
  • Prepare tracking tool and other methods for status reporting
  • Report on progress for Workstream to project milestones, as well as insure sub-milestone reporting for Green Light process, Information Transfer, Regulatory Affairs activities and other activities as assigned
  • Review PVA for consistency with milestone plan
  • Report on progress of PV Agreement completion
  • Plan, manage and lead PV Agreement team meetings, if delegated by PVA lead
  • Collect and collate comments and decisions on regular basis
  • Be proactive in ensuring the successful completion of the PV Agreement
  • Train client´s functional team for Data Transfer activities and system usage (ANGEL transfer, LSA training, Box training etc)
  • Maintain inventory of information exchange with support from the data/information reviewer and RDI/ISSA/AIM teams

Specific Skills required:

  • Highly organized, proactive, and detail oriented
  • Experienced communicator and facilitator
  • Effective time manager
  • Proficient in standard business productivity tools (e.g. Microsoft Office package)
  • Strong understanding of template standard language for PV Agreement
  • Working knowledge of Regulatory and Patient Safety legislation, worldwide, and standard documentation/document types including understanding of GDP, GPV
  • Strong team building capabilities
  • Good organization and problem-solving skills
  • Ability to establish and maintain effective working relationships with a diverse set of Global internal/external cross functional co-workers, managers and clients

Qualifications:

  • 2 or more years in a Project Management role leading similar sized efforts
  • 6 or more years working in a Regulatory (Regulatory Affairs and Patient Safety/Pharmacovigilance) role including assisting in the developing regulatory submission documents and coordinating delivery to submission plans
  • 4 or more years working in a Regulatory or Patient Safety role with exposure to (reviewing/authoring) PVAs
  • Experience in regulatory requirements for asset transfers

Knowledgeable in worldwide RA and PV Regulations, ICH guidance

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: R1065832