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Senior Regulatory Affairs Consultant (Labeling Strategy) UK

Employer
Parexel
Location
United Kingdom
Salary
Competitive
Start date
17 May 2019
Closing date
4 Jun 2019

View more

Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

A Senior Consultant must:-

* have a comprehensive understanding of the organization's consulting models and methodologies, as well as, profound knowledge within a business context of what services PC provides
* develop specialist knowledge of a particular subject matter or market
* provide a broad range of consulting services and works within project guidelines to identify, refine, and address client issues and to achieve project objectives
* serve either as an individual contributor, a workstream lead or provides overall project leadership
* provide guidance to project team members on technical/process issues
* ensure the timely performance of work within a project scope to the quality expectations of PC and the client
* anticipate next client need and qualifies opportunity with the client or obtains introduction to other client decision makers

Qualifications

Knowledge and Experience:
  • Experienced in labeling strategy, PLR format, FDA requirements for drug product labeling; SPL creation or editing a plus
  • Extensive years of experience in a pharmaceutical industry-related environment; experience with a regulatory agency (such as FDA, MHRA) is a plus

    Skills:
  • High-level consulting skills
  • Critical thinking and problem-solving skills
  • Project leadership
  • Excellent interpersonal and intercultural communication skills, both written and verbal
  • Client-focused approach to work
  • Results orientation
  • Teamwork and collaboration skills

    Education:
  • Minimum of a Bachelor's Degree in a Scientific or Technical Discipline, Advanced Degree Preferred
  • Company

    Parexel International Corporation is a leading global biopharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, Parexel has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Parexel Informatics, Inc., a subsidiary of Parexel, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process.

     

    Mission: Parexel’s mission is to combine the strength of our expertise, experience and innovation to advance the worldwide success of the bio/pharmaceutical and medical device industries in preventing and curing disease.

     

    Company info
    Website
    Telephone
    +44 1895 238000
    Location
    The Quays
    101-105 Oxford Road
    Uxbridge
    Middx
    UB8 1LZ
    GB

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