argenx

United in our commitment to improve the lives of patients

Senior Medical Writer

Medical writerMedical writerFull TimeRemoteTeam 1,001-5,000Since 2008H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

9 days ago

Salary

$128K - $176K / year

Bachelor Degree3 yrs expEnglishVault

Job Description

• Author and project manage SME contribution to develop content for regulatory submissions that is well-organized, consistent, accurate, and compliant with argenx 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 lead writer and project teams to ensure project deadlines are met • Executes corporate objectives, goals, measures, and strategies • Capable of working on multiple deliverables simultaneously

Job Requirements

  • Bachelor’s degree in a scientific or clinical discipline or related field is required; Ph.D. preferred
  • Minimum of 3 years of related, sponsor-level pharma or biotech clinical/regulatory medical writing experience required; CRO experience considered
  • Native/bilingual or fluent American English proficiency
  • Experience with Veeva 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 within a clinical development environment from protocol design through regulatory submission
  • Familiarity with pharmacovigilance guidelines and developing aggregate reports
  • Ability to work precisely 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

Benefits

  • Health benefits
  • 401(k) matching
  • Short-term and long-term incentive programs
  • Retirement savings plans

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