MMS · 8 hours ago
Senior Quality Control Reviewer - United States - Remote (Project-Based)
United States
Full-time
Remote
Senior Level
5+ years expMMS is an award-winning, data-focused clinical research organization (CRO) that supports the pharmaceutical, biotech, and medical device industries. They are seeking a Senior Quality Control Reviewer to ensure the quality and correctness of various regulatory documents and to contribute to a collaborative and innovative team environment.
BiotechnologyHealth CareLife Science
Responsibilities
Proficient with templates, toolbars, and macros
Able to adapt to different client style guides and document formatting requirements
Proficient with correcting grammar & spelling errors, with ensuring intra- and inter-document consistency
Proficient with ensuring scientific sense and the correctness of data interpretation
Proficient with the QC of a wide range of regulatory documents, including Investigators Brochure, Protocols, protocol amendments and summaries of changes, ICFs and ICF amendments, CSRs (synoptic, abbreviated, interim, full, addendum), Briefing Documents and Meeting Requests, Assessment Aids, Health Authority Responses, CTD clinical modules (especially strong experience with 2.7.1, 2.7.2, ISI)
Additionally, proficient with the QC of a wide range of med comms documents would be advantageous but not necessary, including Slide Decks, Posters, Abstracts, Manuscripts
Qualification
Required
Minimum of 5 years' experience in Quality Control or similar field required
Proficient with templates, toolbars, and macros
Able to adapt to different client style guides and document formatting requirements
Proficient with correcting grammar & spelling errors, with ensuring intra- and inter-document consistency
Proficient with ensuring scientific sense and the correctness of data interpretation
Proficient with the QC of a wide range of regulatory documents, including Investigators Brochure, Protocols, protocol amendments and summaries of changes, ICFs and ICF amendments, CSRs (synoptic, abbreviated, interim, full, addendum), Briefing Documents and Meeting Requests, Assessment Aids, Health Authority Responses, CTD clinical modules (especially strong experience with 2.7.1, 2.7.2, ISI)
Proficiency with MS Word and Excel
Clear and timely communication, able to work with others to clearly understand needs and solve problems
Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process
Preferred
College graduate in a scientific, medical, clinical discipline or related field is preferred, but relevant QC experience is acceptable
Additionally, proficient with the QC of a wide range of med comms documents would be advantageous but not necessary, including Slide Decks, Posters, Abstracts, Manuscripts
Company
MMS
MMS Holdings (MMS) is an award-winning, data-focused clinical research organization (CRO) that supports the pharmaceutical and biotech industries with a proven, scientific approach to complex trial data and regulatory submission challenges.
501-1000 employees
H1B Sponsorship
MMS has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (2)
2023 (2)
2022 (8)
2021 (9)
2020 (5)
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
Lindsay Goldberg
2022-06-28Private Equity
Leadership Team
Christopher Schoonmaker
Chief Operating Officer
Kevin Chartier
Principal Advisor, Biostatistics and Submission Planning
Recent News
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