Senior Quality Control Reviewer - United States - Remote (Project-Based)
Canton, MI jobs
Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.
Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit ******************* or follow MMS on LinkedIn.
This is a project-based opportunity and not full time employment.
Senior Quality Control Reviewer
Job Specific Skills:
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
Job Requirements:
College graduate in a scientific, medical, clinical discipline or related field is preferred, but relevant QC experience is acceptable
Minimum of 5 years' experience in Quality Control or similar field required.
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.
Should you not have received a response within 14 days of your application, please consider your application unsuccessful.
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