Contract Medical Writer

This is a fully remote position, open to applicants in United States.

📋 Description

• Support the management of medical writing tasks to ensure efficiency and adherence to regulatory standards.

• Conduct research, develop, and revise protocols, investigator brochures, clinical study reports, pre-IND briefing documents, and IND submissions and updates for Phase I-IV clinical trials/research.

• Aid in formulating corporate practices concerning document management and guidance procedures.

• Collaborate with teams in Programming, Biostatistics, Regulatory Operations, Quality Operations, Project Management, and external partners.

• Create and maintain templates for clinical trial documents and writing guides.

• Lead the development and execution of study protocols and protocol amendments.

• Provide medical writing assistance throughout all phases of clinical trials, including regulatory submissions and necessary documentation.

• Prepare initial IND applications and amendments, protocols and amendments, investigator brochures and updates, interim and final clinical study reports, and IND annual reports.

• Ensure that clinical study documentation meets regulatory standards.

• Coordinate and execute activities in accordance with SOPs.

• Actively manage project timelines and forecasts.

• Conduct quality control of written work.

• Attend sponsor/project team meetings and participate in departmental and organizational initiatives.

• Maintain communication with cross-functional teams and supervise project scope.

• Develop and sustain vendor relationships when necessary.

• Engage in initiatives related to SOP, standardization, methods, techniques, and evaluation criteria.

• Perform additional miscellaneous tasks as required.

⛳️ Requirements

• BS/BA degree in a health-related or life science-related discipline.

• At least 5 years of relevant experience in medical writing is essential.

• Extensive experience in the design, execution, and analysis of clinical studies.

• Experience in the Contract Research Organization (CRO) industry is preferred.

• Excellent organizational abilities.

• 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.

• Understanding of clinical research, including regulatory requirements such as GCP/ICH.

• Strong interpersonal abilities.

• Proficient in Microsoft Office and possess general computer skills.

• Capable of meeting the physical demands of the role, including occasionally lifting and/or carrying up to 10 pounds.

• Ability to work effectively under deadline pressure, manage multiple tasks concurrently, and handle interruptions.

• Capable of safely using cell phones and other mobile devices while driving on Company business and/or Company time, if applicable.

🏝️ Benefits

• Contractors are responsible for their own insurance.

• Flexibility to work in an office or home office setting.

• Noise levels are primarily controlled by the contractor.

• Opportunity to engage in clinical trials/research spanning Phase I-IV.