Principal Medical Writer

Employer
ICON Clinical Research
Location
Raleigh, North Carolina
Salary
Not a constraint
Closing date
10 Oct 2020

View more

Discipline
Clinical Research, Clinical Operations
Hours
Full Time
Contract Type
Permanent
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Medical Writer who specializes in clinical trials with imaging endpoints. 
• Writes and revises study-specific documents including Independent Review Charters
(IRC), Site Imaging Manuals (SIM) and Independent Review Training Manuals
(IRTM).  
• Understands key reading criteria such as RECIST, mRECIST, Choi, RANO, Cheson,
Lugano Classification, Halleck, iRECIST, RECIL, iRANO/bmRANO/pedRANO,
PCWG, and PCWG3. 
• Knowledge of current industry regulations and standards. 
• Experience in the oncology therapeutic area. 
• Develops imaging document templates as required by operational leadership to create
efficiencies and development of standard look and feel across documents. 
• Provides input to Standard Operating Procedures and Work Instruction documents for
the medical writing group as necessary. 
• Performs quality control review for other writers as necessary. 
• Attends internal technical team and client team meetings as required. 
• Serves as medical writing representative on assigned project teams. 
• Regularly communicates project related issues with medical and scientific teams and
the project team, as appropriate. 
• Mentors and develops junior Medical Writers.  
• Participates in other non-billable activities as required, including assistance in
maintaining the medical writing work schedule. 
• Strong written and oral communications skills, as well as excellent interpersonal and
negotiation skills. 
• Strong word processing skills including familiarity with MS Office products for
documentation and presentation development. 
Qualifications: 
• Bachelor's degree in Life Sciences/Health Related Sciences or equivalent. 
• Medical/technical writing experience of 5+ years in a clinical research setting. 
• Demonstrated understanding of clinical research, the drug development process, and
applicable regulatory guidelines. 
• Able to work independently. 
• Attention to detail and ability to multitask. 

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life.

We are a global provider of outsourced development and commercialisation services to pharmaceuticalbiotechnologymedical device and government and public health organisations. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas. ICON has been recognised as one of the world’s leading Contract Research Organisations through a number of high-profile industry awards.

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Contact Us
  • 3rd Floor
  • Marlow International
  • Marlow
  • SL7 1YL
  • United Kingdom
  • 01628 496300
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