Senior 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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OptiTrack is a global leader in 3D motion tracking solutions, delivering high-performance motion capture systems for a wide range of applications including virtual production, biomechanics, robotic... Show more
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The Integration Consultant works with Workday’s implementation projects, with a focus on the most strategic and complex projects in Financials.The Integration Consultant develops and maintains inte... Show more
Architectural Specification Writer.HOK is a collective of future-forward thinkers and designers who are driven to face the critical challenges of our time.We are dedicated to improving people's liv... Show more
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Senior Technical Program Manager (Sr TPM), Global IT PMO.This role will be based in Denver, CO, in alignment with Vantage's flexible work policy (3 days in-office, 2 days flexible).The Senior Techn... Show more
The average salary range is between $ 85,890 and $ 146,345 year , with the average salary hovering around $ 103,775 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
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