Medical Digital Content Writer

Cambridge, MA | Contract to Hire

Post Date: 04/06/2018 Job ID: 226025 Industry: IT
This position will generate textual content for the TryME4U™ app which serves as digital reference for patients considering enrollment into a clinical a clinical trial and to support them during the clinical trial if they enroll. 


Key Responsibilities:
 
• Taking complex scientific medical text such as protocols and informed consent documentation and generating easily understood explanatory text for the TryME4U™ app being developed by the Takeda Digital Accellerator team. 

• Ensuring grammatical accuracy of generated text. 

• Ensuring generated content meets all regulatory requirements for language for documents that support clinical trials. 

• Actively participate in and contribute to generation of content for an app that will be used by patients for facilitate their enrollment process into the clinical trial. 

• Ensure content meets regulatory required standard for content that will undergo review by Institutional Review Boards 

• Ensuring generated content meets all regulatory requirements for language for documents that support clinical trials. 


Key Requirements:
 
• Bachelor Degree or higher-level degree in Creative Writing with a Biological or Medical Background. 

• Advanced knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents. 

• Extensive knowledge of FDA and ICH regulations and industry standards applicable to the design, analysis of clinical trials and regulatory submissions. 

• Extensive knowledge of FDA and ICH regulations and industry standards applicable to the design, analysis of clinical trials and regulatory submissions associated with medical apps. 

• Excellent oral and written communications skills. 

• Strong collaborative skills and ability to work with a cross-functional team. 

• Ability to sit and stand for long periods of time. 

• Carrying, handling and reaching for objects. 

• Ability to lift and carry over 25 pounds. 

• Manual dexterity to operate office equipment i.e. computers, phones, etc. 
• Access to transportation to attend various meetings held in close proximity to the company’ s main offices.


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