Medical Writing Manager (Hybrid)

General Summary

The Medical Writing Science Manager is responsible for preparing moderately complex clinical and regulatory documents and represents Medical Writing Science as a cross-functional team member at clinical study level activities.
Key Duties and Responsibilities

Authors moderately complex clinical regulatory documents (e.g., clinical study protocols, clinical study reports, investigator’s brochures, and sections of regulatory submissions) with cross-functional stakeholders
Serves as the lead Medical Writing Scientist for moderately complex clinical studies
Supports Medical Lead with review/interpretation of clinical study data and study team questions
Develops key messages for moderately complex clinical regulatory documents
Ensures medical and scientific consistency between related documents/studies in a clinical program
Analyzes and interprets data to determine best approach to composing each document
Contributes to product development plans (providing prior study information, scientific input, integrating/reviewing data) and serves as coordinating author
Participates in developing standard operating processes and related procedures
Knowledge and Skills

Superior written and oral communication skills
Experience writing and editing clinical regulatory documents
Ability to analyze, interpret, and summarize moderately complex data
Broad understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology
Ability to manage project teams, build relationships, and work through conflicts
Excellent project management and organizational skills
Self-sufficient, resourceful approach with guidance/mentoring as needed
Initiative/creativity in solving problems affecting multiple documents and improving cross-functional processes
Advanced computer skills (word processing, templates, table/figure creation, literature searches, electronic review systems, document management systems)
Education and Experience

Ph.D. (or equivalent degree)
Typically 4 years of experience or equivalent education/experience

#J-18808-Ljbffr