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Job Details

Regulatory Affairs Officer 2 - Office based, Reading, UK

Company: IQVIA
Location: Reading
Reference: 1807721
Closing Date: 23 Sep 18
Type: Full Time
Salary (£): Negotiable
Benefits:

Job Summary:

PURPOSEPrepares and/or reviews regulatory submissions to support clinical trial and marketing authorisation activities for either internal and/or external clients. With guidance from senior staff, provides regulatory support for more complex projects.RESPONSIBILITIESActs as a Regulatory Team Leader on more complex projects, which may include technical writing.Prepares and/or reviews regulatory documentation in area of expertise, as appropriate. ...

Requirements:

PURPOSE


Prepares and/or reviews regulatory submissions to support clinical trial and marketing authorisation activities for either internal and/or external clients. With guidance from senior staff, provides regulatory support for more complex projects.


RESPONSIBILITIES

  • Acts as a Regulatory Team Leader on more complex projects, which may include technical writing.
  • Prepares and/or reviews regulatory documentation in area of expertise, as appropriate.
  • Establishes relationships with many customers; may meet face to face without rest of the team to discuss regulatoryissues, present lessons learned and discuss customer comments.
  • Understands the Scope of Work, deliverables and management of budget for any given project and manages workload asappropriate.
  • May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in theirtraining and development.
  • May present to clients on complex regulatory processes at large full service bid defence meetings by phone or in person.
  • May act as reviewer for regulatory SOPs, as assigned and appropriate.
  • May prepare and deliver regulatory training to IQVIA small groups or individuals.
  • Performs other tasks or assignments, as delegated by Regulatory management.


All responsibilities are essential job functions unless noted as nonessential (N).

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES


Possesses a specific regulatory or technical expertise

Good, solid interpersonal communication (oral and written) and organisation skills

Strong software and computer skills, including MS Office applications

Demonstrates self-motivation and enthusiasm

Demonstrates negotiation skills and is confident in making decisions with minimal supervision

Ability to work on several projects, retaining quality and timelines

Ability to follow SOPs consistently; provides independent thought to assist in process improvements


MINIMUM REQUIRED EDUCATION AND EXPERIENCE


•Degree in life science-related discipline or professional equivalent plus at least 3 years relevant experience* or high schooldiploma plus at least 7-9 years experience* (*or combination of education, training and experience)


PHYSICAL REQUIREMENTS


Extensive use of telephone and face-to-face communication requiring accurate perception of speech

Extensive use of keyboard requiring repetitive motion of fingers

Regular sitting for extended periods of time

Travel will be required

Apply for this job: Regulatory Affairs Officer 2 - Office based, Reading, UK

Contact Information:

Address:  London Office
210 Pentonville Road London
N1 9JY
England
Tel:  +44 (0) 20 3075 5000
Website:  Visit Our Web Site

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