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Full Time
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Job description

Position: Technical Writer (Medical Device & Combination Products)

Location: Cambridge, MA (100% remote)

Duration: 6 Months

Time Commitment: Ideally 20-30 hours/week; willing to negotiate

Job Description:

Our large pharma client is looking to bring on additional support for their upcoming submissions. They are looking for an individual with experience with medical devices/combination products, specifically within the US, to provide technical summaries of reports on device testing, frame and address FDA questions, and provide a summary of what is in the technical documents.

Minimum Qualifications:

  • Bachelor's degree and a minimum of 1-2 years working with FDA submissions.
  • Experience working with Medical Device or Combination Product Submissions for the US.
  • Experience supporting pharmaceutical submissions and applications, addressing FDA questions, and summarizing technical documents.

Responsibilities:

  • Develop high-quality medical device (Point of Care) product labeling & documentation content for a diverse audience, including end users, system administrators, and medical professionals.
  • Produce technically precise and well-written content for use in online help, user guides, Quick Start Guides, IFUs, and other labeling documentation to support POC products.
  • Work with product managers, engineers, regulatory, Marketing and other cross functional staff to gather content; proactively engage with subject matter experts.
  • Manages the writing, reviewing and maintenance of controlled documentation according to regulatory requirements.

What’s In It For You:

The opportunity to work for a client that is reimaging medicine to improve and extend people's lives using innovative science and digital technologies to create transformative treatments in areas of great medical need. This company's products reach nearly 800 million people globally - impacting about 180,000 people of more than 140 nationalities around the world.

Job Types: Part-time, Contract

Pay: $45.00 - $55.00 per hour

Benefits:

  • Dental insurance
  • Health insurance
  • Vision insurance

Schedule:

  • 4 hour shift
  • 8 hour shift

Application Question(s):

  • Have you been employed by either a Medical Device or a Pharmaceutical company?

Education:

  • Bachelor's (Required)

Experience:

  • Technical writing: 2 years (Required)
  • FDA submissions: 2 years (Required)

Work Location: Remote

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