FBL ClinWriters
Published
February 1, 2021
Location
Telecommute
Job Type
Work Setting
Remote / Home-based

Description

Serves as a senior medical writer on clinical study or regulatory project teams. Plans and coordinates report-writing activities with dependent staff roles to ensure satisfactory completion of all writing projects, as well as mentors and leads less experienced medical writers on complex projects.

Position Responsibilities

  • Mentors and leads less experienced medical writers on complex projects, as necessary.
  • Compiles, writes, and edits medical writing deliverables, and serves as a medical writer on internal and external project teams with minimal supervision. Provides medical writing deliverables covering late-stage phases of clinical research (Phase 2 and 3) and in immunology and infectious disease therapeutic areas.
  • Creates writing deliverables that include, but may not be limited to: clinical study reports; integrated summary reports; and NDA and (e)CTD submissions.
  • Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
  • Interacts with client department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
  • Serves as peer reviewer on internal review team.
  • Performs on-line clinical literature searches, as requested.

Requirements

  • PhD, MD, or PharmD degree with a minimum of 3 years of industry regulatory writing and clinical medical writing experience.
  • Master’s level degree with a minimum of 7 years of industry regulatory writing and clinical medical writing experience.
  • Understanding of clinical data.
  • Exceptional writing skills are a must.
  • Excellent organizational skills and the ability to multi-task are essential prerequisites.
  • Candidate must be an expert in MS Word, Excel, PowerPoint, and related word processing tools.
  • Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus. Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.
  • Substantial Oncology, Immunology, and/or Infectious Disease experience required.
  • Substantial eCTD authoring, as lead author, required.
  • Experience leading and managing teams while authoring regulatory documents with aggressive timelines.
  • Regulatory or medical writing certification a plus.
  • Experience in regulatory submissions (pivotal clinical study reports) presented to regulatory authorities a plus.

Travel Requirements

0 to <5%

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