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Project Manager and Business Analyst RIM (Regulatory Information Management) / Large Pharma Group

Employer
Turner Regulatory
Location
Essex/Hertfordshire/Flexible, UK
Salary
Competitive
Start date
29 Sep 2021
Closing date
29 Oct 2021

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Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Project Manager and Business Analyst RIM (Regulatory Information Management) - this desirable role is for a Large Pharma in Hertfordshire/Essex.

The RIM Project Manager will be responsible for Development and implementation of the Regulatory Affairs business systems strategy required to ensure that Global Regulatory Affairs (GRA) systems continue to meet ongoing and emerging business needs. In addition, providing the expert business analysis input required for the development of strategic system roadmaps and for the successful implementation of the projects.

Additional responsibilities are:
  • Liaising with queries on xEVMPD data and reconcile xEVMPD data with the Affiliates
  • Provision of expertise during xEVMPD audits/inspections
  • Generate, monitor, and ensure adherence to compliance metrics and Key Performance Indicators.
  • Provide reports to senior leadership/stakeholders
  • Discuss and resolve annual PV Fee Advice Note review with European Affiliates and accordingly adjust the xEVMPD database
  • Maintain SOP's
  • Maintain an in-depth knowledge of xEVMPD, IDMP, SPOR, TOM, etc.; participate in external working teams (Health Authorities, Industry Forums, etc.); Communicate changes to ensure RIMS Steering Committee and other key stakeholders are kept well informed of any potential impacts
  • Ensure all necessary Training and Mentoring for Staff is in place and for the development of the Team
  • Appropriate Assessment of Staff in line with their development and responsibilities
  • Support of internal project teams to identify and resolve issues while developing opportunities to reduce inefficiencies through new and/or improved IT solutions, business processes or tools
  • Successfully operate within multi-functional teams

Experience you will need for this position:
  • Life Science Degree
  • In-depth knowledge and understanding of pharmaceutical science processes and standards, including xEVMPD, ISO IDMP, SPOR, Standard Terms etc. Understanding of Regulatory Life-cycle management.
  • Experience using and administrating xEVMPD
  • Team Management
  • Working in Cross-functional Teams
  • An eye for detail
  • Must be proficient in Microsoft Word and Excel

A highly competitive salary package including good bonus and leading benefits awaits the successful candidate. Flexible working is offered after the period of the Lockdown.

If you are interested in this, or any other Regulatory Affairs roles, please get in touch with Julian Turner, at Turner Regulatory Recruitment, on 0203 695 9477/07 447 977 330, or by julian@turnerregulatory.com, or apply by clicking Apply Now.

Company

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Brief Company Description; 

Turner Regulatory Recruitment is headed by Julian Turner, whose knowledge of Regulatory Affairs Recruitment is significant, and connections with talented candidates in this area unsurpassed.

Julian Turner started his regulatory recruitment career in 2005, since when Julian and his team have created an outstanding database of candidates and other contacts who are always happy to take our calls.

Our candidates willingly engage with us because we have taken the time to get to know them and to understand their plans and their career ambitions. Indeed, it is quite likely we placed them in one of their roles over the past 15 years.

We work closely with our clients’ regulatory line/senior management, HR and talent acquisition/internal tecruitment teams. When they have a Regulatory Affairs vacancy, they rest assured knowing we will put forward on average ten or more exceptional candidates.

We are often called in where other recruiters have failed and are able to fill long-standing vacancies quickly and effectively.

We are proud to work with clients such as Roche, Norgine, BioMarin, Vertex, Shire, ReNeuron, Seqirus/CSL and numerous other organisations, successfully placing candidates in permanent and contract roles within Regulatory Affairs.

If you have a Regulatory Affairs vacancy and would like the opportunity to select from a pool of excellent candidates, please contact Julian and the team at Turner Regulatory Recruitment.

 

 

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Company info
Website
Mini-site
Turner Regulatory
Telephone
0203 695 9477
Location
71-75 Shelton Street
Covent Garden
London
WC2H 9JQ
United Kingdom

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