Regulatory Document Specialist
1 month ago
MMS Holdings Inc is a leading CRO that supports the pharmaceutical, biotech, and medical device industries with a data-focused approach to complex trial data and regulatory submission challenges.
Job SummaryWe are seeking an experienced Regulatory Document Specialist to join our team. This role will involve critically evaluating, analyzing, and interpreting medical literature to select primary resource materials for clinical development documents.
The ideal candidate will have a strong background in scientific, medical, or clinical disciplines and at least 6 years of experience in regulatory writing. Proficiency in MS Word, Excel, PowerPoint, and related tools is essential.
Key Responsibilities- Critically evaluate and analyze medical literature to select primary resource materials for clinical development documents.
- Write and edit clinical development documents, including protocols, investigator's brochures, study reports, and more.
- Maintain timelines and workflow of writing assignments.
- Collaborate with clients to coordinate project aspects and provide excellent communication skills.
- Bachelor's, Masters, or PhD degree in a relevant field with at least 6 years of experience in regulatory writing.
- Exceptional writing skills and proficiency in MS Office tools.
- Strong industry knowledge and understanding of clinical data.
The estimated salary for this position is around $90,000 - $110,000 per year, depending on experience and qualifications.
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