Duration: 2 months to start
Job Description:
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. This role contributes scientific knowledge and analytical skills to the development of clinical regulatory documentation, under minimal supervision.
Key Duties and Responsibilities:
- Authors moderately complex clinical regulatory documents (e.g., including clinical study protocols, clinical study reports, investigator’s brochures, and sections of regulatory submissions) in partnership with key cross-functional stakeholders
- Serves as the lead Medical Writing Scientist for moderately complex clinical studies
- Supports Medical Lead with review and interpretation of clinical study data and addressing questions from study team members
- Participates in developing key messages for moderately complex clinical regulatory documents
- Ensures medical and scientific consistency between related documents or studies in a clinical program
- Analyzes and interprets data thoroughly and critically to determine the best approach to composing each document
- Contributes to product development plans (e.g., provide information from previous studies, provide scientific input, integrate and review data) and serves as coordinating author for product development plans
- 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, form productive working relationships, and work through conflicts
- Excellent project management and organizational skills
- Ability to complete work in a resourceful, self-sufficient manner and design alternative approaches to achieve desired results, with some guidance and mentoring on new or complex issues
- Initiative and creativity in solving routine problems that affect multiple documents and in identifying and contributing to improvements in cross-functional process
- Advanced computer skills related to word processing, templates, table/figure creation, literature searches, electronic review systems, and document management systems; can act as a resource for others for these tools
Education and Experience:
- Ph.D. (or equivalent degree)
- Typically requires 4 years of experience or the equivalent combination of education and experience
