Contract Medical Writer

🔥 0 minutes ago

🇺🇸 United States – Remote

⏳ Contract/Temporary

🟡 Mid-level

🟠 Senior

🏥📝 Medical Writer

👻 Ghost score 11%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Evolution Research Group

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2014

💼 Consulting

🏥 Healthcare

🧬 Biotechnology

Consulting • Healthcare • Biotechnology

Evolution Research Group is a clinical research organization dedicated to advancing medical science through innovative clinical trials. Specializing in therapeutic areas such as psychiatry, neurology, pain management, addiction, and various chronic conditions, ERG collaborates with healthcare providers and advocacy organizations to ensure inclusivity and thorough patient recruitment. With a robust database of potential participants and expertise in early-phase trials, Evolution Research Group aims to transform healthcare by supporting the development of life-changing therapies.

📋 Description

• Assist in managing medical writing activities to ensure efficiency and regulatory compliance • Research, create, and edit protocols, investigator brochures, clinical study reports, pre-IND briefing books, and IND submissions and updates for Phase I-IV clinical trials/research • Assist with developing corporate practices related to document handling and guidance procedures • Collaborate with Programming, Biostatistics, Regulatory Operations, Quality Operations, Project Management, and external teams • Develop and maintain clinical trial document templates and writing guides • Lead development and implementation of study protocols and protocol amendments • Provide medical writing support throughout clinical trial lifecycles, including regulatory submissions and required documents • Prepare initial IND applications and amendments, protocols and amendments, investigator brochures and updates, interim and final clinical study reports, and IND annual reports • Ensure clinical study documentation complies with regulatory requirements • Coordinate and execute activities according to SOPs • Proactively manage project timelines and projections • Perform quality control of work • Participate in sponsor/project team meetings and departmental and organizational initiatives • Maintain communication with cross-functional groups and monitor project scope • Cultivate and maintain vendor relationships when applicable • Participate in SOP, standardization, methods, techniques, and evaluation-criteria initiatives • Perform other miscellaneous duties as required

🎯 Requirements

• BS/BA in a health-related or life science-related field • A minimum of 5 years of relevant experience in medical writing is required • Extensive experience in the design, execution, and analysis of clinical studies • Experience in the Contract Research Organization (CRO) industry is preferred • Excellent organizational skills • Strong written and verbal communication skills • Exceptional attention to detail • Familiarity with drug safety, US and international regulatory guidelines, drug development, biostatistics, pharmacology, and clinical trial methodology • Knowledge of clinical research including regulatory requirement GCP/ICH • Strong interpersonal skills • Proficiency in Microsoft Office and computer skills • Ability to perform the physical demands of the role, including periodically lifting and/or carrying up to 10 pounds • Ability to work under deadline pressure, handle multiple tasks simultaneously, and manage interruptions • Ability to practice safe use of cell phones and other mobile devices while driving on Company business and/or Company time, if applicable

🏖️ Benefits

• Contractor shall be responsible for their own insurance • May work in an office or home office environment • Noise level largely controlled by the contractor • Opportunity to work on clinical trials/research across Phase I-IV

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