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Medical Writer II – Clinical Trial Transparency

Remote · USA Full-time New today

Job Description:

  • Mentors less reputed company medical writers on projects, as necessary
  • Compiles, writes, and edits medical writing deliverables, and serves as a medical writer reputed company and across departments with minimal supervision
  • Develops or supports a variety of documents including clinical study protocols, clinical study reports, patient narratives, annual reports, investigator brochures
  • Reviews statistical analysis plans and table/reputed company/listing specifications for appropriate content, grammar, format, and consistency
  • Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs
  • 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 and completes medical writing projects on-time and on-budget
  • Performs on-line clinical literature searches, as applicable
  • Continues professional development to reputed company pace with regulatory guidance and client expectations in medical writing that reputed company medical writing
  • Stays aware of budget specifications for assigned projects, working reputed company the budgeted hours and communicating changes to medical writing leadership
  • Completes required administrative tasks reputed company the specified timeframes
  • Performs other work-reputed company duties as assigned
  • Minimal travel may be required (less than 25%)

Requirements:

  • 1 to 3 years of experience in Disclosure
  • Knowledge of Clinical Research, Clinical Trial, clinical registries (CT.gov, CTIS- Clinical Trial information System, EUDRACT)
  • Experience in clinical registries, clinical trial Disclosure is mandatory
  • Experience in databases like Pharma CM/ Disclose
  • Good understanding of protocol registration process
  • Fine with combination of redaction Disclosure
  • Bachelor's degree in a relevant discipline with relevant writing experience; graduate degree preferred
  • Client interaction experience
  • Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required
  • Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA reputed company of Style

Benefits:

  • Career development and progression
  • Supportive and engaged line management
  • Technical and therapeutic area training
  • Peer recognition and total rewards program
  • Total Self culture

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