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.
- 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.
- 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.
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