Technical writer • thornton co
About MMS MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory sub... Show more
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KORE1, a nationwide provider of staffing and recruiting solutions, has an immediate opening for a Technical Recruiter in Denver, Co.Being a strategic partner for hiring managers, capable of driving... Show more
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We are seeking a driven, high-performance Technical Recruiter to source, engage, and place top-tier tech talent in a fast-paced, metrics-driven environment.This opportunity offers uncapped earning ... Show more
Director, Technical Accounting.At Prologis, we don't just lead the industrywe define it with a 1.We create the intelligent infrastructure that powers global commerce, seamlessly connecting the digi... Show more
Founded in 1919, KJ has always looked to the future.With a talented team of professionals and a culture of continuous improvement, we deliver exceptional engineering, environmental consulting, and ... Show more
Crusoe is on a mission to accelerate the abundance of energy and intelligence.As the only vertically integrated AI infrastructure company built from the ground up, we own and operate each layer of ... Show more
We are collecting demographic data from applicants and employees to ensure nondiscrimination in all aspects of employment as well as for federal and/or state reporting purposes. Show more
Loft Federal is committed to delivering the U.At Loft, we empower our team with autonomy, ownership, and bold problem-solving opportunities while fostering a tight-knit, supportive environment.We b... Show more
ProSidian Seeks a Technical Writer (On-site Scribe & AAR) | Dam Operator Safety Training: Fundamentals, Inspection, Monitoring & Field Practicum [DOI0015014] for Training on a Exempt 1099 Contract:... Show more
This position is responsible for monitoring the technical aspects of the SGS Natural Resources, Energy, North American Operations in conjunction with requirements of the Quality Management System a... Show more
As a Technical Recruiter at Candid Health, you'll serve as a strategic partner and advisor to our Engineering, Product, and Design organizations, with a primary focus on full lifecycle recruiting f... Show more
KORE1, a nationwide provider of staffing and recruiting solutions, has an immediate opening for a Technical Recruiter in Denver, Co.Being a strategic partner for hiring managers, capable of driving... Show more
The Grant Writer And Coordinator.Maria Droste Counseling Center.Nonprofit, Part-time, Development, $34 - $38 per hour.The Grant Writer And Coordinator is a part time role based on-site in Denver, C... Show more
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San Francisco, CA/ New York, NY/ Denver, CO.Hightouch is an Agentic Marketing Platform powered by the industry-leading Composable CDP.With complete brand context, customer data, and performance his... Show more
As a Technical Coordinator, you serve as a critical link between technical expertise and operational execution, partnering closely with the planning team to enable efficient and effective service d... Show more
The average salary range is between $ 60,000 and $ 109,666 year , with the average salary hovering around $ 75,695 year .
About MMS MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges.
With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating.
Our mission is to deliver high-quality service and technology solutions – rooted in strong science and decades of regulatory experience – that will assist our clients in developing and marketing life-changing therapies to positively improve lives worldwide.
MMS recognizes that a talented staff is what drives our business forward.
Identifying and attracting top talent and continual training to strengthen core skills are essential to its core mission.
At MMS, enthusiasm, collaboration, and teamwork are fostered, knowing that a global and diverse talent pool makes the company stronger. For more information, visit www.mmsholdings.com or follow MMS on LinkedIn .
Responsibilities Under minimal supervision, the Medical Writer will critically evaluate, analyze, and interpret the medical literature to select primary resource materials for adequate study design, statistical significance, scientific rigor and absence of bias Write and edit clinical development documents, including but not limited to, clinical protocols, investigator’s brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, Module 2.7.1, 2.7.2, 2.7.3, 2.7.4, and 2.5 documents, presentation materials and publications to medical journals Complete writing assignments in a timely manner Maintain timelines and workflow of writing assignments Practice good internal and external customer service Highly proficient with styles of writing for various regulatory documents Expert proficiency with client templates & style guides Interact directly and independently with client to coordinate all facets of projects; competent communicator skills for projects Contribute substantially to, or manages, production of interpretive guides Take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance as necessary Mentor medical writers and other members of the project team who are involved in the writing process Requirements At least 3 years of previous experience in the pharmaceutical industry Must have at least 3-5 years of industry regulatory writing and clinical medical writing experience The ideal candidate would hold a Bachelors, Masters, or Ph.D. in scientific, medical, clinical discipline Substantial clinical study protocol experience, as lead author, required Experience leading and managing teams while authoring regulatory documents with aggressive timelines Experience in regulatory submissions (clinical study reports) presented to regulatory authorities a plus Understanding of clinical data Exceptional writing skills are a must Excellent organizational skills and the ability to multi-task are essential prerequisites Candidate must be an expert in MS Word, Excel, PowerPoint, and related word processing tools Experience being a project lead, or managing a project team Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus Not required, but experience with orphan drug designations and PSP/PIPs a plus Powered by JazzHR
