Skip to main content

This job has expired

Principal Specialist, Global Regulatory Affairs /Clinical Trial Applications and SSU /Home based

Employer
Turner Regulatory
Location
Homeworking
Salary
60,000 - 75,000
Start date
7 Jun 2019
Closing date
4 Jul 2019

View more

Discipline
Clinical Research, Study Start Up, Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

Job Details

Principal SSU & Regulatory Specialist
Home-based
Permanent role

I am seeking a Principal SSU & Regulatory Specialist for a leading CRO.

Clinical Trial Applications, and other Clinical Regulatory activity – Liaison with Regulatory Authorities and Ethics Committees.

You will perform assigned activities within the country that lead to start-up of investigative sites in all phases of clinical trials. You will be responsible for providing delivery and expertise, with minimal oversight from the SSU Country Manager in a number of the following functional areas: investigator site contracts, ethics and regulatory submissions, and review and finalization of essential documents required for site initiation. Accountable local activities are undertaken in accordance with agreed timelines, allocated budgets, and required quality standards. Ensures an efficient start-up process on assigned studies. May act as main contact with Regulatory Authorities (RA) and Central/Regional Ethics Committees (ECs). Under the direction of the Project Lead (PL) or SSUL as appropriate, may directly interact with Customers when receive requirements from RA or other local regulatory party. Accountable to the PL/SSUL at the project level and line manager for deliverables. May act as the Country Start-Up Advisor (CSA) or as a line manager / mentor for less experienced staff. At a project level, may act as SSUL for local or regional studies.

The ideal candidate will need the following experience / skills to be considered:

  • Bachelor’s Degree
  • Excellent understanding of clinical trial process across Phases II-IV and ICH GCP
  • Good understanding clinical protocols and associated study specifications
  • Excellent understanding of clinical trial start-up processes
  • Project management experience in a fast-paced environment
  • Good vendor management skills
  • Strong organizational skills with proven ability to handle multiple projects
  • Excellent communication, presentation and interpersonal skills
  • Quality-driven in all managed activities
  • Strong negotiating skills
  • Strong problem-solving skills
  • Ability to mentor, lead and motivate more junior staff
  • Demonstrate an ability to provide quality feedback and guidance to peers
  • Contribute to a training and Quality assurance plan within SSU and update SOPs/WI

A highly competitive salary package is offered to the right candidate..

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 9477/07447 977 330, or julian@turnerregulatory.com, or submit an application by clicking Apply Now.

Company

Find out more about working for our company

Turner-Regulatory-Recruitment -hub-button

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.

 

 

 Follow us on LinkedIn...

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

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert