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Contract Medical Writer
Evolution Research Group. Assist in managing medical writing activities to ensure efficiency and regulatory compliance .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in medical writing for clinical trials, ensuring compliance with regulatory requirements and effective communication across cross-functional teams. Proficient in developing clinical trial documents and managing project timelines while maintaining high attention to detail.
Highest-signal resume keywords
Medical WritingClinical Trial DocumentationRegulatory ComplianceProject ManagementClinical Research
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Study ReportsProtocolsIND SubmissionsBiostatisticsDrug DevelopmentGCP/ICH GuidelinesQuality ControlDocument HandlingClinical Trial MethodologyStatistical Analysis
Soft Skills
Organizational SkillsWritten CommunicationVerbal CommunicationAttention to DetailInterpersonal Skills
Tools & Technologies
Microsoft OfficeDocument TemplatesWriting Guides
Industry Keywords
Contract Research OrganizationRegulatory GuidelinesDrug SafetyClinical TrialsHealth-Related Field
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Assist in managing medical writing activities to ensure efficiency and regulatory compliance
- Research, create, and edit protocols, investigator brochures, clinical study reports, pre-IND briefing books, and IND submissions and updates for Phase I-IV clinical trials/research
- Assist with developing corporate practices related to document handling and guidance procedures
- Collaborate with Programming, Biostatistics, Regulatory Operations, Quality Operations, Project Management, and external teams
- Develop and maintain clinical trial document templates and writing guides
- Lead development and implementation of study protocols and protocol amendments
- Provide medical writing support throughout clinical trial lifecycles, including regulatory submissions and required 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 according to SOPs
- Proactively manage project timelines and projections
- Perform quality control of work
- Participate in sponsor/project team meetings and departmental and organizational initiatives
- Maintain communication with cross-functional groups and monitor project scope
- Cultivate and maintain vendor relationships when applicable
- Participate in SOP, standardization, methods, techniques, and evaluation-criteria initiatives
- Perform other miscellaneous duties as required
Requirements
What you’ll need- BS/BA in a health-related or life science-related field
- A minimum of 5 years of relevant experience in medical writing is required
- Extensive experience in the design, execution, and analysis of clinical studies
- Experience in the Contract Research Organization (CRO) industry is preferred
- Excellent organizational skills
- 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
- Knowledge of clinical research including regulatory requirement GCP/ICH
- Strong interpersonal skills
- Proficiency in Microsoft Office and computer skills
- Ability to perform the physical demands of the role, including periodically lifting and/or carrying up to 10 pounds
- Ability to work under deadline pressure, handle multiple tasks simultaneously, and manage interruptions
- Ability to practice safe use of cell phones and other mobile devices while driving on Company business and/or Company time, if applicable
Benefits
Comp & perks- Contractor shall be responsible for their own insurance
- May work in an office or home office environment
- Noise level largely controlled by the contractor
- Opportunity to work on clinical trials/research across Phase I-IV