Senior Medical Writing Specialist - Spark Life Solutions Inc
Deerfield, IL 60015
About the Job
Roles & Responsibilities:
" With oversight, develops high quality clinical documents ensuring scientific excellence and regulatory compliance. The development process includes writing, interpreting, and summarizing clinical and non-clinical data, compiling information, and ensuring delivery within timelines.
" Clinical documents may include investigator brochures, protocols, clinical study reports, integrated reports, clinical sections of core technical documents/new drug applications/briefing documents per regulations, manuscripts/abstracts for publication and/or presentation.
" Ensure compliance of clinical documents with national and international regulatory requirements and guidelines and procedures.
" Work closely with cross functional team members and serve as MW representative at study team meetings.
" Prepare document timelines, with guidance from manager, as needed.
" Conduct literature searches.
" Develop deeper knowledge of specific therapeutic areas.
Education & Experience:
" The Senior Medical Writing Specialist must have a BS or MS in scientific or clinical discipline with excellent writing skills. 5 years of on-the-job experience in scientific/medical writing (e.g., clinical trial and regulatory documents) preferred but not mandatory.
" Experience in scientific and/or medical writing.
" Experience in the analytical evaluation of scientific data and written or oral presentation in a logical, clear, concise manner.
" Strong organizational skills and meticulous attention to detail.
" Familiarity with clinical trial-related and regulatory clinical submission templates and documents.
" Ability to apply global regulatory authority regulations and/or guidance.
" Manage multiple projects with competing priorities.
" Medical statistics knowledge
" Proficient in Mircosoft Office Suite (Word, Excel, PowerPoint, OneNote, Outlook, Teams
" With oversight, develops high quality clinical documents ensuring scientific excellence and regulatory compliance. The development process includes writing, interpreting, and summarizing clinical and non-clinical data, compiling information, and ensuring delivery within timelines.
" Clinical documents may include investigator brochures, protocols, clinical study reports, integrated reports, clinical sections of core technical documents/new drug applications/briefing documents per regulations, manuscripts/abstracts for publication and/or presentation.
" Ensure compliance of clinical documents with national and international regulatory requirements and guidelines and procedures.
" Work closely with cross functional team members and serve as MW representative at study team meetings.
" Prepare document timelines, with guidance from manager, as needed.
" Conduct literature searches.
" Develop deeper knowledge of specific therapeutic areas.
Education & Experience:
" The Senior Medical Writing Specialist must have a BS or MS in scientific or clinical discipline with excellent writing skills. 5 years of on-the-job experience in scientific/medical writing (e.g., clinical trial and regulatory documents) preferred but not mandatory.
" Experience in scientific and/or medical writing.
" Experience in the analytical evaluation of scientific data and written or oral presentation in a logical, clear, concise manner.
" Strong organizational skills and meticulous attention to detail.
" Familiarity with clinical trial-related and regulatory clinical submission templates and documents.
" Ability to apply global regulatory authority regulations and/or guidance.
" Manage multiple projects with competing priorities.
" Medical statistics knowledge
" Proficient in Mircosoft Office Suite (Word, Excel, PowerPoint, OneNote, Outlook, Teams
Source : Spark Life Solutions Inc