Senior Medical Writer - Medical Communications

Sr Medical Writer - Medical Communications/Pubs

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?

We are looking for passionate, resilient, and inspiring individuals to join our team. As a Sr Medical Writer, you will provide medical/clinical writing support for as part of a dedicated team servicing a particular pharmaceutical client. This includes development of outlines, manuscripts, abstracts, scientific posters, and slide presentations that are generally focused on a specific therapeutic area.

The role

• To independently write, edit and compile documents that are components of clinical/regulatory marketing approval applications for new biologics, drugs, or devices, and to direct other medical writers in the writing, editing and compilation of documents
• To assist in the management of medical writing resources
• Interpret clinical data
• Write clinical trial reports and other regulatory documents
• Provide additional writing and editing services as required (e.g. for publications)
• 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
  
• Be 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
• 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
• Interpret and summarise data from biostatistical summary tables and listings accurately, precisely, and concisely into narrative text

What you need

• Minimum of 3-5 years as Medical Writer in a Medical Communications/Publications Agency
• You must have an advanced science degree (PharmD, PhD or MD, etc)
• Excellent demonstrable understanding of ICMJE and GPP guidelines and regulations required.
• Ability to read, analyze, and interpret common scientific and technical journals.
• Ability to respond to common inquiries or complaints from customers.
• Ability to write presentations and articles for peer reviewed publications that conform to prescribed style and format.
• Must demonstrate a command of the English language (read, write and speak).
• Ability to work with mathematical concepts such as probability and statistical inference.
• To perform this job successfully, an individual should have knowledge of Internet software, Spreadsheet software, Word Processing software, Graphics software (eg, PowerPoint or Prism), Biliographic software eg, EndNote) and any other applicable software as may be needed by the job from time to time as it changes.
• Must demonstrate strong experience in relationship building and experience in collaborating with large and strategic accounts.