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Drug Device Combination CMC support

  • Location: Boston
  • $ Salary: US$48.00 - US$52.00 per hour per hour
  • Job Type:Contract

Posted 17 days ago

  • Sector: Life Sciences
  • Contact: Yasmin Sweeney
  • Duration: 6 Months
  • Start Date: ASAP
  • Expiry Date: 17 June 2023
  • Job Ref: 18894

*Please email your up to date CV to "yasminsweeney@hydrogengroup.com" if interested in this position*

Job Description

A leading Biotech company are actively seeking a motivated candidate to fill their Drug Device Combination CMC support opportunity. This is an initial 6-month contract, with opportunity to extend/ convert to FTE. This is an onsite role based out of Boston, MA with a salary range of $48-52/hr depending on experience. This role involves providing Combination Device CMC support for Quality Assurance processes.

Qualifications:

  • Bachelor's degree and 0 - 3 years of relevant work experience in the Biotech or Pharmaceutical industry, or relevant comparable background.
  • Good Understanding of regulations, guidelines, procedures, and policies relating to development, registration, and manufacturing of drug-device to expedite the submission, review and approval of global CMC applications.

Key Responsibilities:

  • Assists in CMC QA activities to support clinical development, submission, and approval of drug-device combination product.
  • Support device design control activities and documentation reviews.
  • Preparation of Device History File.
  • Preparation of Human Factor Risk Analysis.

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