Medical Writer

ICON plc (Bangalore, KA, India) 9 days ago

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 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

We have roles open in the below 3 areas

Imaging (Medical Writer I)

  • 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

General Medical Writing (Sr Medical Writer)

  • Write clinical trial reports and other regulatory documents
  • Experience in writing CSRs, Protocols, Investigator Brochures, DSURs, PSURs (safety documents), submission documents
  • Provide additional writing and editing services as required (e.g. for publications)
  • Advise on the content and format requirements for clinical reports and regulatory documents

Narrative Writing (All levels)

  • Write patient narratives for serious adverse events and drop-outs due to non-serious adverse events; write the reports of clinical trials and other regulatory documents (including) according to ICON or client-specified formats
  • Provide additional writing and editing services (e.g. for publications) as required
  • Assist in the production of preclinical summaries, clinical summaries, pharmacokinetic reports, safety summaries, literature reviews, and other documents needed for regulatory submissions

Candidates are expected to

  • Perform quality control (review) of documents and assess whether specific project related documents comply with regulatory requirements, client requests and ICON SOPs
  • Participate in non-project specific activities, including assistance in maintaining the medical writing work schedule
  • Responsible for the daily management of assigned medical writing projects
  • Liaise with project managers and statisticians to ensure the timely implementation of activities related to the production of reports
  • Keep Medical Writing management informed of project status (e.g. in relation to quality, timelines, progress, and problems)
  • Participate in the training and supervision of new and junior medical writers
  • Represent Medical Writing at internal and external meetings
  • Assist Business Development with the preparation of proposals and cost estimates for medical writing tasks where applicable

What you need

  • Bachelor's degree in a life science/health related sciences, or equivalent
  • Medical/Technical writing experience of 3 to 14 years in a clinical research setting
  • Outstanding written and verbal interpersonal skills
  • Ability to work effectively and cooperatively with other team members
  • Understanding of clinical research, the drug development process, and applicable regulatory guidelines

Why join us

Other than working with an outstanding team of ambitious people, we also offer a very competitive benefits package. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.

We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.

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.

ICON is an equal opportunity employer and committed to providing a workplace free of any discrimination or harassment.

EOE race/colour/religion/sex/sexual orientation/gender identity/disability/vet/national origin

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Medical Writer

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