Medical Writer I / Medical Writer II, CSR Narratives
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Medical writer creating clinical narratives, study reports, and regulatory documents for Syneos Health’s life sciences services. Reviewing clinical data and ensuring compliance with FDA, ICH-E3, and client standards.
Responsibilities:
- Mentor less experienced medical writers on projects as necessary
- Compile, write, and edit medical writing deliverables with minimal supervision
- Develop or support clinical study protocols, protocol amendments, clinical study reports, patient narratives, annual reports, and investigator brochures
- Review statistical analysis plans and table/figure/listing specifications for content, grammar, format, and consistency
- Interact with data management, biostatistics, regulatory affairs, and medical affairs teams to produce writing deliverables
- Serve as a peer reviewer and address team comments for scientific content, clarity, consistency, and format
- Follow ICH-E3 guidelines, company SOPs, client standards, and approved templates while completing projects on time and on budget
- Perform online clinical literature searches as applicable
- Continue professional development related to regulatory guidance and client expectations
- Monitor project budget specifications and communicate changes to medical writing leadership
- Complete required administrative tasks and perform other assigned duties
- Travel minimally when required (less than 25%)
Requirements:
- Minimum 1 year of experience working in narratives with a master's qualification, or 2 years of experience with graduation
- Postgraduate (Masters / Mpharm) or bachelor's degree
- Good experience in drafting and reviewing narratives
- Extensive knowledge of English grammar, FDA and ICH regulations and guidelines, and familiarity with AMA style guide
- Effective presentation, proofreading, interpersonal, and leadership skills
- 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
- Working knowledge of the drug development process and regulatory guidelines
Benefits:
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Inclusive culture
- Minimal travel (less than 25%)
Similar Jobs
Medical Writer
Medical Writer generating synthetic clinical trial data and authoring CSRs. Helping Mercor train frontier AI models through expert clinical documentation.
Medical Writer I
Medical Writer supporting ICON’s global healthcare intelligence and clinical research organization. Managing clinical and regulatory document QC, EDMS workflows, and submission readiness.
Medical Writer – Medical Information
Medical Writer crafting clinical study reports, protocols, and regulatory documents for Thermo Fisher Scientific's pharmaceutical and CRO clients. Supporting scientific communication, quality compliance, and deliverable planning.
Clinical Documentation Specialist – Session Checker
Session Checker reviewing healthcare service sessions and documentation for accuracy and compliance. Identifying discrepancies and coordinating corrections across clinical, administrative, scheduling, and billing teams.
Clinical Documentation Specialist
Clinical Documentation Specialist reviewing inpatient charts for accurate documentation and DRG coding. Supporting Guidehouse’s healthcare services through compliant physician queries and clinical documentation improvement.
Principal Medical Writer – Publications
Principal Medical Writer developing clinical and regulatory publications for Syneos Health’s life-sciences services. Leading complex documents, reviews, client coordination, and regulatory-compliant medical writing.
Clinical Documentation Integrity Specialist
Remote CDI Specialist reviewing clinical records, querying providers, and managing appeals. Supporting Mosaic Life Care’s mission as a Missouri health care system through accurate coding.
Associate Medical Writer – Neuroscience Publications
Associate Medical Writer creating neuroscience publications and scientific content for BOLDSCIENCE, a medical communications agency. Supporting slide decks, manuscripts, digital materials, and meeting materials while developing expertise across therapy areas.
Clinical Documentation Specialist
Clinical Documentation Specialist ensuring accurate patient medical records for a healthcare organization. Applying coding and compliance expertise to support quality outcomes and provider education.
Clinical Documentation Integrity Specialist I, Relief, Non-benefitted
Clinical Documentation Integrity Specialist improving inpatient and outpatient records for Stanford Health Care. Reviewing documentation, coding, physician queries, and DRGs to support accurate healthcare outcomes.
Clinical Documentation Specialist
Clinical Documentation Specialist improving inpatient records for Tidelands Health, South Carolina’s largest nonprofit healthcare provider. Reviewing clinical documentation, supporting coding accuracy, and educating medical staff on documentation requirements.
Clinical Documentation Integrity Specialist I, Relief
Clinical Documentation Integrity Specialist improving medical-record accuracy, severity capture, and coding compliance for Stanford Health Care. Reviewing records, querying physicians, and partnering with coding teams on patient outcomes and reimbursement.
Sponsor Dedicated Medical Writer II/Sr
Medical writer leading clinical, regulatory, and scientific documents for Syneos Health, a life sciences services organization. Collaborating with biopharmaceutical clients and cross-functional clinical teams.
Clinical Documentation Integrity Specialist
Remote RN clinical documentation specialist improving inpatient medical records for Memorial Hermann. Supporting accurate coding, DRG assignment and physician documentation through review, education and coaching.
Clinical Documentation Auditor, Educator
Memorial Hermann CDI Auditor/Educator auditing clinical documentation and coding across acute-care facilities. Educating physicians and CDIS staff while improving record quality, severity capture, and compliance.
Senior Medical Writer – FSP
Medical Writer producing clinical study reports, protocols, and regulatory documents for Thermo Fisher Scientific. Supporting pharmaceutical/CRO projects through scientific writing, quality compliance, and program coordination.
Health Plan Document Writer
Health plan document writer translating complex self-funded benefit information into compliant SPDs, amendments, SBCs, and restatements for CVS Health. Ensuring accurate, customer-ready documentation.
Co-Founder & CEO – AI Clinical Documentation Compliance
Co-Founder & CEO leading Concordance, an AI clinical documentation compliance venture auditing healthcare charts in real time. Driving customer pilots, product development, fundraising, and founding-team formation.
Co-Founder & CEO – AI Clinical Documentation Compliance
Co-Founder & CEO leading Concordance, an AI venture auditing healthcare charts for payer-specific documentation compliance. Driving pilots, product development, fundraising, and founding-team recruitment.
Co-Founder & CEO – AI Clinical Documentation Compliance
Co-Founder & CEO building Concordance, an AI platform auditing healthcare charts for payer-specific documentation compliance. Leading customer pilots, product development, fundraising, and founding-team recruitment with FutureSight.