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