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Medical Writing II (CSR Narrative, QC review)
Syneos Health
posted 4 days ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
Mentors less experienced medical writers on projects, as necessary.
Compiles, writes, and edits medical writing deliverables, and serves as a medical writer within and across departments with minimal supervision.
Develops or supports a variety of documents that include but not limited to: o Clinical study protocols and clinical study protocol amendments; o Clinical study reports; o Patient narratives; o Annual reports; o Investigator brochures.
Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
Serves as peer reviewer on internal review team. Addresses team comments accurately to ensure document scientific content, clarity, overall consistency, and proper format.
Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as we'll as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget.
Performs on-line clinical literature searches, as applicable.
Working knowledge of drug development process and regulatory guidelines.
Continues professional development to keep pace with regulatory guidance and client expectations in medical writing that affect medical writing.
Stays aware of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.
Completes required administrated tasks within the specified timeframes.
Performs other work-related duties as assigned.
Minimal travel may be required (less than 25%).
Qualifications
- Min 3 years of medical writing experience and minimum 3yrs of relevant experience in Narrative writing
- Good Experience of independent authoring and reviewing CSR Narratives only.
- Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise.
- Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as we'll as a familiarity with AMA style guide.
- Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team-oriented approach.
- Strong proficiency in Word, Excel, PowerPoint, email, and Internet.
- Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information.
Employment Type: Full Time, Permanent
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Flexible timing
Monday to Friday
No travel
Day Shift
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