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Medical Writer I – CSR Narrative
Syneos Health. Compile, write, and edit medical writing deliverables with moderate supervision .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in medical writing, including clinical study reports and narrative writing, while adhering to regulatory guidelines such as ICH-E3 and FDA standards. Proficient in utilizing tools like Word and Excel to produce high-quality deliverables within budget and time constraints.
Highest-signal resume keywords
Medical Writing ExperienceClinical Study Report (CSR) Narrative WritingBachelor of Science or Bachelor of Arts DegreeUnderstanding of FDA and ICH RegulationsProficiency in Word, Excel, and PowerPoint
ATS Keywords
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Hard Skills
Medical WritingNarrative WritingClinical Study Protocol DevelopmentStatistical Analysis Plan ReviewClinical Literature SearchesEditing and ProofreadingData InterpretationRegulatory Guidance KnowledgeBudget ManagementTime Management
Soft Skills
Effective Presentation SkillsInterpersonal SkillsTeam-Oriented Approach
Tools & Technologies
Microsoft WordMicrosoft ExcelMicrosoft PowerPointEmailInternet
Industry Keywords
ICH-E3 GuidelinesAMA Style GuideClinical Research PrinciplesFDA RegulationsMedical AffairsBiostatisticsData Management
About the role
Key responsibilities & impact- Compile, write, and edit medical writing deliverables with moderate supervision
- Serve as a medical writer within and across departments
- Develop or support clinical study protocols and amendments, clinical study reports, patient narratives, and investigator brochures
- Review statistical analysis plans and table/figure/listing specifications for content, grammar, format, and consistency
- Provide feedback to define required statistical output
- Interact with department heads and staff in data management, biostatistics, regulatory affairs, and medical affairs
- Adhere to ICH-E3 guidelines, company standard operating procedures, client standards, and approved templates
- Complete medical writing projects on time and within budget
- Perform online clinical literature searches as applicable
- Continue professional development regarding regulatory guidance and client expectations
- Work within budgeted hours and communicate changes to medical writing leadership
- Complete required administrative tasks within specified timeframes
- Perform other assigned work-related duties
Requirements
What you’ll need- Minimum 1 year of medical writing and narrative writing experience
- Well versed in CSR Narrative writing, including drafting and authoring
- Bachelor of Science degree with relevant writing experience, or Bachelor of Arts degree in Social Sciences, English, or Communications with relevant scientific and/or medical knowledge and expertise
- Extensive knowledge of English grammar
- Familiarity with AMA style guide
- Understanding of FDA and ICH regulations and guidelines strongly preferred
- Effective presentation, proofreading, and interpersonal skills
- Team-oriented approach
- Strong proficiency in Word, Excel, PowerPoint, email, and Internet
- Familiarity with principles of clinical research
- Ability to interpret and present clinical data and other complex information
- Minimal travel may be required (less than 25%)
Benefits
Comp & perks- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Inclusive culture
- Reasonable accommodations when appropriate for employees or applicants with disabilities