Clinical & Regulatory Medical Writing Senior Manager (Hybrid)

Role Summary

Clinical & Regulatory Medical Writing Senior Manager (Hybrid) – The Medical Writing Science Senior Manager is responsible for independently authoring complex clinical study documents and sections of regulatory submissions to support all phases of clinical drug development. This role may represent Medical Writing Science as a cross-functional team member for study-level and program-level activities.

Responsibilities

• Authors complex clinical regulatory documents (e.g., clinical study protocols, clinical study reports, investigator‚Äôs brochures, documents to support meetings with regulatory agencies, and sections of marketing authorization applications) in partnership with key stakeholders
• Serves as the lead Medical Writing Scientist for complex or pivotal clinical studies for multiple programs or therapeutic areas
• Provides expert review of study-level and program-level documents
• Participates in developing key messages for complex clinical regulatory documents
• Provides leadership on teams responsible for defining the direction and regulatory strategy for a clinical development program
• Provides strategic and scientific contributions to regulatory documentation in support of the clinical development pipeline
• Contributes to content and strategy of presentations for regulatory agency advisory committee meetings; may prepare advisory committee briefing documents
• Ensures document preparation is compliant with company and industry standards
• Strong contributor on cross-functional teams working on standard operating procedures, process improvements, and integration of new tools and technologies

Knowledge And Skills

• Outstanding written and oral communication skills
• Extensive experience writing and editing clinical regulatory documents
• Ability to analyze, interpret, and summarize highly complex data
• Advanced understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology
• Ability to mediate conflicts by negotiating, compromising, persuading, and facilitating the open exchange of ideas and opinions
• Highly developed project management and organizational skills
• Ability to manage challenging, high-value projects
• Initiative and creativity in solving complex problems; ability to have a substantial role in developing and implementing improvements in cross-functional processes

Education

• Ph.D. (or advanced degree in a relevant life science field)
• Typically requires 6 years of experience or the equivalent combination of education and experience.