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Salary range: 
£30,000 to £35,000
Job/scheme locations: 
Kidlington, Oxfordshire.
Type of opportunity: 
Immediate job
Application deadline: 
14/07/2020
Background
Developing a new drug can take up to 15 years and cost in excess of $1 billion. Regulatory writers are specialist medical writers, whose role it is to prepare the formal and scientific documents that pharmaceutical companies need during the development of a drug. Such documents are required by drug licensing authorities, such as the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). Hence, regulatory writers play an important role in helping to get new drugs to the market and in improving patient care.
 
Main responsibilities
  • Preparing medical writing documentation to a high standard with supervision from a more experienced writer
  • Participating in client project teams and meetings as appropriate
  • Liaising with client personnel and external contacts to ensure that documentation is produced to a high standard and in accordance with agreed timelines
  • Performance of quality control review of medical writing documentation to a high standard
  • Ensuring medical writing activities comply with regulatory guidelines and company/client standard operating procedures.
Your profile:
If you would like to move away from research and academia but still apply your scientific knowledge and skills, regulatory writing might be the right career for you.
Ideal candidates will have:
  • PhD in Life Sciences or similar
  • Excellent command of spoken and written English
  • Meticulous attention to detail
  • Strong interpersonal skills, and an ability to interact confidently with colleagues, clients, and external experts
  • Ability to work independently and as part of a team
  • Proficient use of Word, Excel, PowerPoint and literature databases including PubMed
  • Exceptional time-management and organisational skills, including the ability to manage a workload across multiple projects
  • Excellent research ability: to quickly get to grips with new therapeutic areas
  • Ability to evaluate, interpret and present scientific data with clarity.
 
Why Insight MW?
By joining Insight MW you will become a part of a dynamic team which is committed to providing excellence in regulatory documentation. Our writers are among the best available and you can benefit from their wealth of experience with in-house training and support, supplemented with external training provided by the European Medical Writers Association. All new writers are assigned a mentor to support them in their personal and professional development. We also offer a generous remuneration package and benefits to successful applicants. 

For more information, or to apply, please send your CV and cover letter via the 'Apply by email' button.
Selected applicants will be invited to interview and to complete a 30-minute writing test.

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More about this vacancy

Region: 
South East
Number of vacancies: 
Up to 5
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