Parexel - Medical Writer II - UK / Ireland / Spain / Poland / Czech

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Headline


This role can be based at either our Head Office situated in Uxbridge, Madrid or Dublin or be fully home-based anywhere in the UK, Ireland, Spain, Poland or Czech Republic. As a Medical Writer II you will research, create, edit, and coordinate the production of clinical documents associated with submissions to regulatory authorities. You will also be responsible for the production of clinical study documentation associated with clinical trials that may not be included in a regulatory submission. You may also serve as the primary client contact.


Responsibilities

  • Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize clinical documents for submission to regulatory authorities.
  • Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input.
  • Perform literature searches/reviews as necessary to obtain background information and training for development of documents.
  • Review statistical analysis plans and mock statistical output to determine appropriateness of content at for clinical writing.
  • Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize clinical documents for submission to regulatory authorities.

Knowledge and experience

  • Demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g., ICH-GCP.
  • Extensive clinical/scientific writing skills.
  • Scientific background essential; writing experience includes multiple clinical documents: study reports, study protocols, or CTD documents or similar.
  • Advanced word processing skills, including MS Office (expertise in Word); software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring and file conversion and databases (Excel).
  • Fluent in written and spoken English with appropriate attention to phraseology, grammar, and punctuation.

Your profile

  • Bachelor's degree in Life Sciences / Health related Sciences or equivalent.
  • Excellent interpersonal, negotiation, verbal, and written communication skills.
  • A flexible attitude with respect to work assignments and new learning.
  • Motivation to work consistently in a fast-paced, rapidly changing environment.
  • Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail, e.g., organizational skills.

In return we will be able to offer you a structured career pathway and development within the role including awareness and understanding of the industry. Your hard work will be rewarded with a competitive salary, as well as a benefits package including 25 days holiday per year, a strong contributory pension scheme, life assurance, long term disability insurance, private medical and private dental cover


Are you ready for your Parexel Journey?


Are you ready to be part of a dynamic team that is making a difference in the lives of patients worldwide?

APPLY HERE

Upcoming Conference

Cascais Save the Date

The 52nd EMWA conference will take place on 4 - 6 November 2021 at the Hotel Cascais Miragem.