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Job Details

PRINCIPAL MEDICAL WRITER - United Kingdom

Company: PRA Health Sciences
Location: United Kingdom (London, Reading, Home-based)
Reference: CCr-2017-43350
Closing Date: 17 Dec 17
Type: Full Time
Salary (£): Competitive
Benefits: Excellent Salary and Benefits

Job Summary:

An outstanding opportunity to join one of the world’s leading contract research organisations and be part of a dynamic and growing international company. Join PRA Health Sciences as a Principal Medical Writer and help realize your career potential.

Requirements:

PRINCIPAL MEDICAL WRITER

Location: United Kingdom (London, Reading or Home-based)

Be part of our exciting new strategic partnership!

PRA Health Sciences is a top 5 CRO and winner of CRO of the year for Europe, Asia and North America in 2015 and 2016

Our strategic partner is the largest pharmaceutical company in Asia and a top 15 pharmaceutical company in the world.

Embedded within our newest strategic partner and reporting to the Senior Director of Medical Writing, you will be a highly motivated and dynamic medical writing professional with a strong commercial knowledge of the pharmaceutical industry, a positive attitude and ambition to make things happen. 

At PRA we are heavily focused on career development.  There is lots going on in the Medical Writing team, the role will grow and the selected applicant will be fulfilled.  The team is constantly reviewing the needs of the team - so, if you are a motivated and anbitious Medical Writer, the sky is the limit.

This position can be office based in London or Reading, or home based.

 

Responsibilities:

  • Researches, writes, and edits clinical documents by applying functional expertise and clinical drug development knowledge.
  • Leads a single team which guides medical writing activities within a designated therapeutic or functional area for key response documents and regulatory submissions.
  • Leads the writing strategy providing expertise including organization, content, timelines, and resource requirements.
  • Provides more complex advanced input for study designs, analysis plans, sections of INDs and marketing applications
  • Provides review and substantive editing of contributions, and ensures resolution of issues.
  • Within designated therapeutic or compound function, manages deliverables and preparation of documents for submission to FDA or other regulatory agencies, ensuring consistency of content within therapeutic areas and adherence to regulatory requirements and Sponsor requirements and processes across development programs.
  • Represents Medical Writing on cross-functional teams and task forces (related to projects, process, and standards).
  • As required, serves as lead writer for important regulatory response documents and key components of regulatory submissions.
  • Provides leadership on functional teams that address requirements or issues related to document preparation and production.
  • The Principal Medical Writer is seen as an expert in medical writing and performs work independently with minimal supervision.

Desired skills and qualifications:

Bachelor’s degree in science, health profession, or journalism required.  

You will need substantial experience writing for pharma or biotechnology required.  

Experience as lead writer for key documents included in major US and/or international regulatory submissions required.

Experience managing writing activities for a major US or international regulatory submission (project or people management) preferred.


Together with a competitive salary, PRA will offer a comprehensive range of benefits and an excellent working environment. As we continue to expand, there will be career opportunities on a truly global scale.

PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

If you have any questions please email recruiteruk@prahs.com or call our recruitment department at +44 (0) 1189 213652

Apply for this job: PRINCIPAL MEDICAL WRITER - United Kingdom

Contact Information:

Address:  Head Office
500 South Oak Way
Green Park
Reading
Berkshire
RG2 6AD
England
Tel:  +44 (118) 918 1000
Fax:  +44 (118) 918 1001
Website:  Visit Our Web Site

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