Senior Medical Writer: Lead Regulatory Docs

OpenKrill; United States; Teletrabalho; USD 110 000 - 150 000; Tempo integral

Resumo da oferta

TransPerfect is seeking a senior medical writer to lead planning and preparation of high-quality clinical regulatory documents. You'll collaborate with Clinical Development, Regulatory, and other teams to deliver protocols, reports, and modules on brisk timelines.

Responsibilities include managing timelines, coordinating contributors, and ensuring templates and templates align with client processes. Strong English and MS Word skills are essential.

Qualificações

• 5+ years of medical writing experience in CRO/biotech/pharma.
• Bachelor’s degree or higher in a relevant field.
• Experience writing protocols, study reports, regulatory documents.
• Ability to work independently and with competing priorities.
• Familiarity with ICH and US regulatory requirements.

Responsabilidades

• Lead the execution of documents and manage timelines.
• Coordinate cross-functional contributors and internal resources.
• Ensure documents follow client processes and templates.
• Serve as expert on document management systems and tools.
• Lead kickoff meetings and manage review feedback.
• Ensure consistency across programs in messaging and formatting.
• Conduct literature searches and perform peer QC as needed.

Conhecimentos

Project management

Cross-functional collaboration

Regulatory writing

Excellent communication

English proficiency

Conflict resolution

Lean authoring

Structured content

Independent worker

Formação académica

Bachelor’s degree or higher

Ferramentas

Microsoft Word

Document management systems

Collaborative authoring tools

Review tools

Descrição da oferta de emprego

TransPerfect is seeking a senior medical writer to lead planning and preparation of high-quality clinical regulatory documents. You'll collaborate with Clinical Development, Regulatory, and other teams to deliver protocols, reports, and modules on brisk timelines.

Responsibilities include managing timelines, coordinating contributors, and ensuring templates and templates align with client processes. Strong English and MS Word skills are essential.