Contract Medical Writer

Evolution Research Group•CRO Remote, US,

About The Position

The Contract Medical Writer supports medical writing activities for clinical trials and research from Phase I through Phase IV, including researching, creating, and editing clinical and regulatory documents. These documents include protocols and amendments, investigator brochures and updates, clinical study reports, pre-IND briefing books, IND applications and updates, and annual reports. The role also supports corporate practices for document handling, creates guidance procedures, and ensures clinical writing adheres to regulatory requirements, SOPs, and corporate standards. The Medical Writer collaborates with internal and external teams, coordinates project activities and timelines, performs quality control, participates in sponsor and project meetings, maintains communication across functions, monitors project scope, and cultivates vendor relationships when applicable. The contractor is responsible for their own insurance.

Requirements

Bachelor of Science or Bachelor of Arts degree in a health-related or life science-related field.
At least 5 years of relevant medical writing experience.
Extensive experience in the design, execution, and analysis of clinical studies.
Excellent organizational skills.
Strong written and verbal communication skills.
Exceptional attention to detail.
Familiarity with drug safety principles, US and international regulatory guidelines, drug development, biostatistics, pharmacology, and clinical trial methodology.
Knowledge of clinical research and GCP/ICH regulatory requirements.
Strong interpersonal skills.
Proficiency in Microsoft Office and computer skills.
Ability to meet the stated physical demands, including regularly reaching with hands and arms, periodically lifting or carrying up to 10 pounds, and occasionally stooping, bending, kneeling, crouching, and pushing or pulling filled wheeled carts.
Required vision abilities include close vision, color vision, and ability to adjust focus.

Nice To Haves

Master’s degree.
Experience in the Contract Research Organization (CRO) industry.

Responsibilities

Collaborate with Programming, Biostatistics, Regulatory Operations, Quality Operations, Project Management, and other internal and external teams.
Develop and maintain document templates tailored for clinical trials.
Create and maintain clinical-trial-specific writing guides.
Lead the development and implementation of study protocols and protocol amendments.
Provide medical writing support throughout clinical study lifecycles, including regulatory submissions and required study 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 in accordance with SOPs.
Proactively manage project timelines and projections.
Perform quality control to ensure project quality.
Participate in sponsor and project team meetings.
Contribute to departmental and organizational meetings and initiatives.
Communicate with cross-functional groups throughout project lifecycles and monitor project scope.
Cultivate and maintain key vendor relationships when applicable.
Participate in corporate initiatives related to SOPs, standardization, methods, techniques, and evaluation criteria for projects, programs, and personnel.
Perform other duties as required.