Softworld Medical Digital Content Writer in Cambridge, Massachusetts

Medical Digital Content Writer

Cambridge, MA

| Contract to Hire

Post Date: 04/06/2018

2018-04-06 2018-05-20

Job ID: 226025

Industry: IT

Job Description

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.