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Medical Writer I

Bangalore Urban
Permanent
Reference: JR066523
Description

At ICON, it's our people that set us apart.

As a global provider of drug development solutions, our work is serious business. But that doesn't mean you can't have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry! Are you one of them?

At ICON, we have an incredible opportunity for an expert Medical Writer (Imaging) to join our team in Bangalore office. This is a rare opportunity to join our friendly global Medical Writing team which sits within ICON's Clinical Research Services group. Our remit is to produce high quality documents supporting clinical studies and regulatory submissions.

The Role

  • Writes and revises study-specific documents including Independent Review Charters (IRC), Site Imaging Manuals (SIM) and Independent Review Training Manuals (IRTM)

  • Develops imaging document templates as required by operational leadership to create efficiencies and development of standard look and feel across document

  • Understands key reading criteria such as RECIST, mRECIST, Choi, RANO, Cheson, Lugano Classification, Halleck, iRECIST, RECIL, iRANO/bmRANO/pedRANO, PCWG, and PCWG3

  • Writing of documents according to agreed contractual obligations and timelines using client or ICON templates and style guides, and adhering to regulatory or other guidance

  • Regularly communicates project related issues with medical and scientific teams and the project team, as appropriate

  • Serves as medical writing representative on assigned project teams

What you need

  • Bachelor's degree in a life science/health related sciences, or equivalent

  • Medical/Technical writing experience of 2 to 4 years in a clinical research setting

  • Ability to assimilate and summarize large volumes of scientific data accurately, clearly and concisely

  • Strong written and oral communications skills

  • Strong word processing skills including familiarity with MS Office products for documentation and presentation development

  • Understanding of clinical research, the drug development process, and applicable regulatory guidelines

Why join us

Ongoing development is vital to us, and as a Medical Writer, you will have the opportunity to progress your career, with the potential to move into other related areas to improve your skillset. Our benefits package is competitive, our scope is international and we sincerely care about our people and their success.

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