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Outlier
Jacksonville, FL, United States
FOR DANISH WRITING EXPERTS ONLY Are you interested in helping to train AI models to become better writers? How it works: We have several open projects where we are looking for talented writers to help train generative artificial intelligence models to become better writers. You can work on all of our projects remotely. Hours are flexible, so yo
Job Source: OutlierOutlier
Jacksonville, FL, United States
FOR RUSSIAN WRITING EXPERTS ONLY Are you interested in helping to train AI models to become better writers? How it works: We have several open projects where we are looking for talented writers to help train generative artificial intelligence models to become better writers. You can work on all of our projects remotely. Hours are flexible, so you c
Job Source: OutlierOutlier
Jacksonville, FL, United States
FOR SIMPLIFIED CHINESE WRITING EXPERTS ONLY If you are looking for the Traditional Chinese writing role you can find it here. Are you interested in helping to train AI models to become better writers? How it works: We have several open projects where we are looking for talented writers to help train generative artificial intelligence models to
Job Source: OutlierNemours Children's Health
Jacksonville, FL, United States
Job Description Nemours is seeking a Executive Content Manager & Senior Speech Writer. Please submit your cover letter, resume and three to five (3-5) writing samples, at least two (2) of which should be a strategic leadership speeches. Primary Functions: The Executive Content Manager & Senior Speech Writer's primary responsibility is to resear
Job Source: Nemours Children's HealthColliers Engineering & Design
Jacksonville, FL, United States
Overview Colliers Engineering & Design is seeking a full-time Grant Writer who can assist Client Managers and engineers in grant research and grant writing. The selected candidate will work with city and county clients and other government agencies as well as a team of engineers and planners across multiple offices and geographic regions to secure
Job Source: Colliers Engineering & DesignFortune 500 Companies
jacksonville, fl
Job Title: Technical Writer Job Location : Deerfield Beach FL & Jacksonville FL 1. Tech writer experience of 4+ years 2. Familiar with writing user stories for technical projects 3. Familiar with cloud technology (AWS or Azure) 4. Comfortable with Excel, ADO board/ Jira board 5. Consolidate task updates from multiple sources and provide daily/week
Job Source: Fortune 500 CompaniesFresenius Kabi USA, LLC
Jacksonville, FL, United States
Job Summary The Senior Director, Medical Affairs will provide global medical leadership for the R&D function of the Fresenius Kabi MedTech business, which includes medical devices and solutions associated with transfusion, cell therapies, and infusion technology. Participate in and guide risk management inputs for development projects, support defi
Job Source: Fresenius Kabi USA, LLCValnet Freelance
Jacksonville
This position will operate on a remote, freelance basis. To be eligible for this opportunity, you must be located in the US or Canada. Are you an NBA enthusiast with experience in sports publishing? GIVEMESPORT.COM is looking for writers to cover impactful NBA content for the website . GIVEMESPORT is one of the world’s largest independent sports me
Job Source: Valnet FreelanceJacksonville, FL, United States
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. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating, and the company has been recognized as a leading CRO inGlobal Health & Pharma’sinternational awards programs for the last three consecutive years. 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
Substantial clinical study protocol experience, as lead author, required
Experience leading and managing teams while authoring regulatory documents with aggressive timelines
Not required, but experience with orphan drug designations and PSP/PIPs a plus
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Senior Medical Writer (Remote) jobs in Jacksonville, FL, United States
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