Clinical Trials Medical Writer

🔥 4 minutes ago

🗽 New York – Remote

🗽 New York – Remote

💵 $77k - $92k / year

⏰ Full Time

🟢 Junior

🏥📝 Medical Writer

👻 Ghost score 0%

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ACM Global Laboratories

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

ACM Global Laboratories is a leading provider of clinical trial testing services, supporting clinical trials globally in over 65 countries. The company offers a range of bioanalytical services, including small and large molecule analysis, biomarker analysis, and various laboratory testing solutions such as routine safety testing, flow cytometry, and advanced sample tracking. ACM Global Laboratories is recognized for its expertise in bioanalysis and toxicology services, ensuring high sensitivity and accuracy in drug and metabolite measurements across diverse biological samples. The company is dedicated to delivering actionable clinical insights and reliable toxicology services to healthcare providers, partnering with clinical trials to optimize development projects through state-of-the-art laboratory services, specimen management, and global logistics.

📋 Description

• Interpret complex clinical study protocols and medical/scientific documentation • Prepare and coordinate laboratory specifications and study-specific medical/technical documents for ACM Global Laboratories • Lead development, revision, and maintenance of complex clinical study documents and amendments in accordance with SOPs and regulatory requirements • Author and finalize global lab specification documents and related documents • Interpret scientific details, identify and resolve documentation gaps, and ensure client satisfaction • Serve as a subject-matter expert for medical documentation throughout the study lifecycle • Lead and manage internal and external document review rounds • Coordinate stakeholders to ensure high-quality technical documentation aligned with business processes • Participate in client interactions during study start-up and amendment processes • Review GLSDs and lab manuals according to SOPs and Quality Assurance processes • Lead development, revision, and maintenance of lab manuals • Resolve challenges and build consensus across cross-functional groups and collaborators • Maintain working knowledge of FDA, MHRA, NYSDOH, GCP, ICH, and other relevant regulations • Resolve complex-study queries using knowledge of regional differences and internal ACM processes • Perform other assigned duties

🎯 Requirements

• BA/BS, or equivalent experience in scientific field • 1 yrs clinical trials or other laboratory experience required • Applied knowledge of routine document content preparation, including the use of style guides, medical dictionaries, regulatory guidance documents, and templates • Proficient in Microsoft Office and desktop publishing or word processing • Education in medical or technical writing • Excellent communication skills • Ability to effectively influence others, work in a team environment, and collaborate across lines of business and functions • 1+ years’ experience drafting clinical trials documentation • Must sit on the East Coast • Ability to work 40 hours per week, Monday–Friday days schedule