Medical Writer II(Plain Language Summary

Description

JOB SUMMARY

Serves as medical writer on Lay Summary (LS) project teams. Writes, edits, perform quality checks (QC), and coordinates the preparation of LS with dependent staff roles to ensure satisfactory completion of all writing projects. A level of client interaction is expected.

Skills Requirements:

• Minimum 2 years of regulatory writing, preferable with Clinical study reports(CSRs).
• Preferable experience writing LS or other patient facing documents, such as Informed Consent Forms (ICFs), Patient information leaflets (PIL)
• Good in English Verbal/ Writing skills.

JOB RESPONSIBILITIES

• Compiles, writes, and edits LS deliverables, and serves as a medical writer within and across programs with minimal supervision.
• Develop a variety of plain language documents such as 2-page protocol lay summary,plain language summary of publications , and other patient-facing materials.
• Interacts with the Sponsor clinical teams and LS Specialist as necessary to produce LS deliverables, coordinate review cycles, attend and run kick-off meetings, and create and track timelines.
• Addresses team comments accurately to ensure document scientific content, clarity, overall consistency, and proper format.
• Adheres to health literacy, and numeracy and readability principles to produce deliverables that are understood by the general public.
• Serves as QC reviewer on internal QC reviews.
• May support with preparation of a variety of documents that include but not limited to:
• Clinical study protocols and clinical study protocol amendments;
• Clinical study reports;
• Patient narratives;
• Investigator brochures.

• Adheres to established regulatory standards, including but not limited to ICH guidelines, as well 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 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.

Qualifications

QUALIFICATION REQUIREMENTS

• Bachelor of Science degree with relevant writing experience.
• Minimum 2 years of regulatory writing, preferable with Clinical study reports(CSRs).
• Preferable experience writing LS or other patient facing documents, such as Informed Consent Forms (ICFs), Patient information leaflets (PIL)
• Good in English Verbal/ Writing skills.
• 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.