MMS Holdings Inc. is a global pharmaceutical service organization (CRO) that focuses on regulatory submission support for the pharmaceutical, biotech and medical device industries. We support pharmaceutical and biotech industries with medical writing, biostatistics, clinical programming, data management, clinical development, regulatory affairs, regulatory submissions and pharmacovigilance.
Our mission is to deliver high-quality services, rooted in good science and decades of regulatory experience, that will assist our clients in developing and marketing life-changing therapies, thereby positively affecting patients' lives worldwide.
MMS is looking to expand regulatory services within the US. We are looking to add several regulatory strategists with experience in these regions to work with our clients who are planning to run clinical trials, file marketing applications and/or engage in regulatory activities with health authorities in these regions. Key activities for regulatory strategists are included below
Note: This is for a variable hours position (part- to full-time)
The Clinical Technical Editor / Scientific Document Reviewer will be a function of the Medical Writing team. Responsible for quality control of clinical documents and will work collaboratively with medical writers to ensure documents comply with regulatory guidelines.
Coordinate and perform quality control for clinical documents including, but not limited to, clinical protocols, investigator brochures, clinical study reports, patient narratives and clinical summaries of the common technical document intended for submission to regulatory agencies.
Proofread, review and edit clinical documents in support of clinical development projects in multiple therapeutic areas and at various stages of development in order to verify:
Completeness and accuracy of information
Accurate use of grammar and style
Internal consistency of document
Compliance with submission/ready standards
Application of format standards
Works within document management system to ensure security and version control
Ensures consistent QC across authors and documents.
Ability to follow sponsor processes