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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in preparing and reviewing clinical documentation, including patient safety narratives and clinical study reports, while adhering to regulatory guidelines and internal procedures. Strong communication and organizational skills are essential for effective collaboration with internal and external clients.
Highest-signal resume keywords
Narrative Writing ExperienceClinical Study Report PreparationKnowledge of MS WordExcellent Written and Verbal CommunicationLife Sciences Degree
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Patient Safety Narrative PreparationClinical Study Report CompilationDocument Review and EditingRegulatory Guidelines ComplianceClinical Documentation Preparation
Soft Skills
Good Organizational AbilityExcellent Interpersonal SkillsTime Management Skills
Industry Keywords
ICH GuidelinesClinical ResearchStandard Operating ProceduresProject ManagementInternal Processes Compliance
About the role
Key responsibilities & impact- Prepare and review patient safety narratives
- Provide support to project management of narrative projects
- Prepare and compile CSR appendices
- Prepare lower complexity documents such as synoptic or abbreviated CSRs, and skeleton CSRs, under guidance of more senior staff as appropriate
- Provide support to more experienced colleagues with the preparation of clinical study protocols and CSRs
- Prepare documents in accordance with Fortrea/Client Standard Operating Procedures and specifications, and relevant ICH and regulatory/industry guidelines
- Incorporate internal and/or external review comments on clinical documentation under guidance
- Communicate with internal/external clients as needed to facilitate achievement of project goals
- Comply with Fortrea internal processes and procedures
- Perform other duties as assigned by Management
- Ensure timely delivery of high-quality documents to internal customers and Sponsors
- Assist with archiving and filing clinical study protocols, CSRs, and associated documentation
- Foster excellent working relationships with internal and external clients
Requirements
What you’ll need- Minimum of first degree in life sciences (or equivalent)
- 1-2 Years of Narrative writing experience
- Excellent command of written and spoken English
- Good written and verbal communication skills
- Knowledge of MS Word
- Good organizational and time management ability
- Excellent interpersonal skills
- Scientific or Clinical research experience desirable
- Regularly required to sit
Benefits
Comp & perks- Overtime and weekend work as required
- EEO & accommodations request support