Senior Medical Writing & Regulatory Manager

MMS Holdings Inc. is seeking an experienced Medical Writer to join our regulatory documentation team. You will ensure compliance with CFR Part 11, FDA, GCP; mentor junior staff; lead complex writing projects from start to finish.

The role requires a strong background in regulatory and medical writing, familiarity with ISO 9001/27001, and ability to manage client expectations and deliver high-quality submissions across clinical trial programs.

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