Medical Writing Manager (Hybrid)

General Summary:
The Medical Writing Science Manager prepares 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 (protocols, clinical study reports, investigator’s brochures, and regulatory submission sections) with cross-functional stakeholders
- Serves as lead Medical Writing Scientist for moderately complex clinical studies
- Supports Medical Lead with review/interpretation of clinical data and study team questions
- Develops key messages for moderately complex clinical regulatory documents
- Ensures medical and scientific consistency between related documents/studies
- Analyzes and interprets data critically to determine best document approach
- Contributes to product development plans and acts as coordinating author
- Participates in developing standard operating processes and procedures

Knowledge and Skills:
- Superior written and oral communication
- Experience writing/editing clinical regulatory documents
- Ability to analyze, interpret, and summarize moderately complex data
- Broad drug development/clinical research/regulatory knowledge (including study designs, biostatistics, pharmacology, terminology)
- Ability to manage project teams and resolve conflicts
- Excellent project management and organizational skills
- Resourceful, self-sufficient; designs alternative approaches with some guidance
- Initiative/creativity improving cross-functional processes
- Advanced computer skills (word processing, templates, table/figure creation, literature searches, electronic review/document management systems)

Education and Experience:
- Ph.D. (or equivalent)
- Typically 4 years of experience or equivalent combination of education/experience

Pay Range:
- $120,200 - $180,400 (annual bonus and annual equity awards mentioned)