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Insulet Corporation Senior Technical Writer in Acton, Massachusetts

The Senior Technical Writer is responsible for planning and executing the generation of new and maintaining released end-user, product related documentation for all Insulet’s devices. The Senior Technical Writer will collaborate and coordinate with key stakeholders and representatives from all technical disciplines, commercial and marketing functions, regulatory and clinical groups, legal counsel, and others to develop instructional materials for Insulet’s global customer base.

  • Plan, coordinate, collaborate, and execute with inputs from all company stakeholders on the creative development, production release, and market launch of all new products’ customer facing product instructional materials.

  • Organize and drive timely reviews and iterations with all subject matter experts and stakeholders (both internal and external) of all instructional documents being developed.

  • Maintain, in a detailed and organized manner, the electronic and hardcopy libraries of all materials used in the development of product labels and instructional materials from development phases through release to production.

  • Compile necessary research and inputs, and write technical documents to support the end use of Insulet’s products and Insulet’s customers.

  • Ensure efficient release and quality hand-off of outputs (documents and materials) to Document Control for sustained design control and production.

  • Manage external resources participating in the generation of customer facing product instructional materials.

  • May perform administrative duties relative to the development and launch of technical publications; such as filing, copying, binding, and archiving, as required and assigned.

  • Actively participate on improvements to relevant SOP’s and on general advancements of processes for operational efficiency and effectiveness.

  • Ensure design, review, production, and maintenance methods and processes are consistent and follow/support the Quality Policy as well as all pertinent ISO Quality System procedures and guidelines.

  • Originate Engineering Change Orders (ECOs) and coordinate technical documentation change efforts to ensure timely completion of change packages through approval.

  • Provide counsel to Purchasing and Operations disciplines for their document production ownership.

  • Conduct Labeling Design Review and participate in Engineering Design Review meetings as required.

  • Report on all tasks and progress on execution following organizational practices and standards established by project leadership.

  • Support and maintain documentation links between Insulet and all external Insulet partners.

  • Performs other duties as required

Minimum Requirements:

  • Bachelor of Arts degree

  • Minimum of 5 years’ related experience writing technical documents or product instructional materials.

  • Minimum of 2 years’ experience within the medical device industry writing/editing scientific/medical material.

  • Ability to understand medical/clinical and technical aspects of diabetes management/care and drug delivery products.

Preferred Skills and Competencies:

  • Bachelor of Science degree in a technical discipline

  • Experience with products marketed to or used by diabetes patients.

Physical Requirements (if applicable):

  • None

External Company Name: Insulet Corporation

External Company URL: http://www.myomnipod.com/

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