Clinical Trials Medical Writer

**Job Title:** Medical Writer **Department:** Study Set Up **Location:** Remote East Coast \| Must Sit in East Coast **Hours Per Week:** 40 hours **Schedule:** Days, Monday – Friday **SUMMARY** The Medical Writer is responsible for interpreting complex clinical study protocols and other medical/scientific documentation to prepare and coordinate laboratory specification and study‑specific medical/technical documents for ACM Global Laboratories. They will partner with internal departments in the development, drafting, review, editing, and finalization of documents used to conduct clinical studies. **RESPONSIBILITIES** * Lead the development, revision, and maintenance of complex clinical study and amendments in accordance to standard operating procedures (SOPs) and regulatory requirements. * With support of a mentor, work on the development, revision, and maintenance of high profile and expedited complex study documents and amendments in accordance to SOPs and regulatory requirements. * Responsible for authoring and finalizing global lab specification documents (GLSD) and other related documents, as needed. * Interpret, understand, and contribute to the scientific details of the protocol/technical documentation; identify and resolve gaps to ensure client satisfaction. * Serve as a subject\-matter expert (SME) for medical documentation utilized throughout the study lifecycle. * Lead, initiate, and manage multiple rounds of internal and external document review. * Liaise and drive timely collaboration between key stakeholders to ensure technical documentation meet high quality standards and aligns with business process. * Participate in client interactions during study start\-up activities and/or during study amendment process. * Review of low to medium complexity GLSD in accordance to SOPs and Quality Assurance processes. * With support of a mentor, work on the review of high complexity GLSD in accordance with SOPs and Quality Assurance processes. * Lead the development, revision, and maintenance of lab manuals in accordance to SOPs and regulatory requirements. * Review lab manuals to ensure alignment with SOPs and Quality Assurance processes. * Resolve challenges and build consensus between all cross\-functional groups and collaborators in a timely manner. * Maintain a general working knowledge of Food \& Drug Administration (FDA), Medical \& Healthcare Regulatory Agency (MHRA), New York State Department of Health (NYSDOH), Good Clinical Practice (GCP), ICH and other pertinent regulations. * Demonstrate initiative in professional self\-development to improve job performance to maintain relevant working knowledge of clinical trials. * Resolve queries for complex studies by using knowledge of regional differences and internal ACM processes for low and medium complexity GLSD and understanding of department responsibilities. * Perform other duties and/or tasks as assigned. **REQUIRED QUALIFICATIONS** * BA/BS, or equivalent experience in sc