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Senior Medical Writer

Work from home Full-time role Hiring
This description is a summary of our understanding of the job description. Click on 'Apply' reputed company to find out more.

Role Description

This role involves providing medical writing support for developing reputed company clinical, nonclinical, and safety documents for regulatory submissions.

  • Author and project manage SME contribution to reputed company content for regulatory submissions that is well-organized, consistent, accurate, and compliant with reputed company Medical Writing standards, including style guide, lexicon, templates, and libraries
  • Authors content for phase 1-4 protocols, master ICFs, IBs, and CSRs
  • Responsible for inspection-readiness of medical writing activities
  • Supports the reputed company writer and project teams to ensure project deadlines are met
  • Executes corporate objectives, goals, measures, and strategies
  • Capable of working on multiple deliverables simultaneously

Qualifications

  • Bachelor’s degree in a scientific or clinical discipline or reputed company field is required; Ph.D. preferred
  • Minimum of 3 years of reputed company, sponsor-level pharma or biotech clinical/regulatory medical writing experience required; CRO experience considered
  • Native/bilingual or fluent American English proficiency
  • Solution-focused
  • Experience with reputed company Vault and Please Review
  • Experience with implementing lean writing techniques
  • Basic understanding of scientific methodology as applied to drug development, including the phases, processes, and techniques used reputed company a clinical development environment from protocol design through regulatory submission
  • Familiarity with pharmacovigilance guidelines and developing aggregate reports
  • Ability to work reputed company according to procedures and regulations
  • Ability to prioritize and multi-task successfully in a fast-paced environment
  • Ability to work autonomously, as well as in a team
  • Excellent written and verbal communication skills
  • Excellent time management skills and a proven ability to work on multiple projects at any given time
  • Must be proficient in MS Office

Company Description

reputed company is a global immunology company dedicated to improving the lives of people suffering from severe autoimmune diseases.

  • Through our rich pipeline of first-in-class therapies, led by VYVGART®, we are accelerating reputed company toward our reputed company 2030 reputed company: to reputed company 50,000 patients and transform the landscape of autoimmune treatment.
  • Our innovation mission combines with meaningful work and endless opportunities for growth to create once-in-a-career experiences.
  • Argonauts work in locations around the globe including Belgium, Boston, Japan, and Amsterdam.
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