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MMS
San Antonio
Job Description Job Description 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
Job Source: MMSMbSolutions Inc
San Antonio
Job Description Job Description Protocol Support San Antonio, Texas Job Qualification: A high school diploma with a minimum two year administrative support experience Ability to clearly communicate in writing and orally, organization skills, time management Able to work professionally with individuals, diverse groups, and the public Proficient i
Job Source: MbSolutions InciNovex Information Systems
San Antonio, TX, United States
Job Brief iNovex is seeking Protocol Analysts to support a program within iNovex's Next-Gen portfolio. Job Description We're searching for talented individuals who provide intelligence, statistical analysis and programming expertise for the Government. This program will maximize the effectiveness and efficiency of our country's most important mi
Job Source: iNovex Information SystemsPyramid Consulting, Inc
san antonio, tx
Immediate need for a talented Senior Technical Writer. This is a 12+ months Contract opportunity with long-term potential and is located in San Antonio, TX (Remote). Please review the job description below and contact me ASAP if you are interested. Job ID: 24-20776 Pay Range: $40 - $45/hour. Employee benefits include, but are not limited to
Job Source: Pyramid Consulting, IncOutlier
San Antonio, TX, United States
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Job Description Job Description Description Become a Medical Scribe First Scribe-X offers unparalleled clinical experience and preparation for medical school. Work from home and gain clinical experience! Receive extensive paid training that will help you master EMR systems and patient documentation procedures. Develop professional mentorsh
Job Source: Scribe-XCareHarmony
san antonio, tx
CareHarmony works comprehensively with providers to deliver value-based care management initiatives for their patients. Our team is driven by their passion for the level of care delivered; experts in assisting patients and caregivers to navigate a sometimes-fractured healthcare system and consistently prioritize a high-quality standard so patients
Job Source: CareHarmonySan Antonio, TX, 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, mostly focusing on clinical protocols but the overall role mayinclude, but is not limited to, 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 andstyle 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 (Protocols) - Remote jobs in San Antonio, TX, United States
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