Clinical Trials Medical Writer

This is a fully remote position, open to applicants in New York.

📋 Description

• Analyze intricate clinical study protocols as well as medical and scientific materials.

• Develop and organize laboratory specifications along with study-specific medical and technical documents for ACM Global Laboratories.

• Oversee the creation, revision, and upkeep of complex clinical study documents and amendments, ensuring compliance with SOPs and regulatory standards.

• Draft and finalize global laboratory specification documents and associated materials.

• Analyze scientific information, pinpoint and address documentation discrepancies, and guarantee client satisfaction.

• Act as a subject matter expert in medical documentation throughout the entire study lifecycle.

• Facilitate and manage both internal and external document review processes.

• Coordinate with stakeholders to ensure the production of high-quality technical documentation that aligns with business practices.

• Engage in client communications during the initiation and amendment phases of studies.

• Review Global Laboratory Specification Documents (GLSDs) and lab manuals in accordance with SOPs and Quality Assurance protocols.

• Direct the development, revision, and maintenance of lab manuals.

• Address challenges and foster consensus among cross-functional teams and collaborators.

• Maintain an up-to-date understanding of FDA, MHRA, NYSDOH, GCP, ICH, and other relevant regulations.

• Tackle complex study inquiries by leveraging knowledge of regional variations and internal ACM processes.

• Execute additional assigned responsibilities.

⛳️ Requirements

• BA/BS degree or equivalent experience in a scientific discipline.

• Minimum of 1 year of experience in clinical trials or related laboratory work.

• Practical understanding of routine document content preparation, including familiarity with style guides, medical dictionaries, regulatory guidance documents, and templates.

• Proficient in Microsoft Office, desktop publishing, or word processing software.

• Educational background in medical or technical writing.

• Strong communication skills.

• Ability to effectively influence others, collaborate in a team setting, and work across various business lines and functions.

• At least 1 year of experience drafting clinical trial documentation.

• Must reside on the East Coast.

• Capability to work 40 hours per week, following a Monday to Friday daytime schedule.

🏝️ Benefits

• Competitive salary and comprehensive benefits package.

• Opportunities for professional development and growth.

• Collaborative and supportive work environment.