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Technical Writer - LifeScience Domain

Salary undisclosed

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Job Description:

We are looking for a highly skilled and detail-oriented Technical Writer with expertise in the Lifescience domain. The ideal candidate will be responsible for creating clear, accurate, and compliant documentation to support scientific research, pharmaceutical development, medical devices, and healthcare solutions. You will collaborate with cross-functional teams to ensure that complex technical concepts are effectively communicated to both technical and non-technical audiences.

Key Responsibilities:

  • Develop and maintain comprehensive technical documentation, including user manuals, regulatory submissions, standard operating procedures (SOPs), clinical study reports, and research protocols.
  • Translate complex scientific and technical information into clear, concise, and accurate documentation tailored for various audiences, including regulatory bodies, healthcare professionals, and internal teams.
  • Write, edit, and format technical content for product releases, regulatory submissions, and compliance requirements.
  • Work closely with scientists, engineers, regulatory teams, and subject matter experts (SMEs) to gather information and understand technical processes, data, and results.
  • Collaborate with the Quality Assurance and Regulatory teams to ensure documentation complies with industry standards (e.g., FDA, EMA, ISO).
  • Ensure all written materials adhere to relevant regulatory and compliance standards such as Good Clinical Practice (Google Cloud Platform), Good Documentation Practice (GDP), Good Manufacturing Practice (GMP), and other lifescience regulations.
  • Assist in preparing documentation for regulatory submissions (e.g., FDA, EMA, CE Mark), including Investigational New Drug (IND) applications, New Drug Applications (NDA), and pre-market approval (PMA) documentation for medical devices.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
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