Senior Associate, Clinical Pharmacology Scientific Support & Reporting Writing

Role Summary

Senior Associate, Clinical Pharmacology Scientific Support & Reporting Writing. Responsible for building data and information for internal scientific reports related to clinical trials, moving multiple reports forward through multi-tasking, and mentoring therapeutic area personnel.

Responsibilities

• Prepare scientific reports and presentations related to clinical trials using available software and templates.
• Assist in constructing Phase 1 clinical study planning documents and write Phase 1 protocols.
• Review clinical protocols and key decisions impacting project timelines with management.
• Comply with procedures in IQS documents, study protocols, and directives issued by management regarding clinical/preclinical studies.
• Analyze clinical study data, including statistical data using available software, to assist with ongoing blinded efficacy and safety reviews and ensure scientific integrity of processes.
• Receive and complete tasks and assignments from Therapeutic Area MD or Scientific Staff within timelines with minimal supervision.
• Ensure scientific integrity of all processes by applying current electronic document conventions and processes consistently and accurately.
• Integrate clinical trial data across studies and identify issues impacting projects; communicate findings to internal peers and therapeutic area management.
• Perform literature/competitive intelligence searches to recognize/resolve scientific and technical problems using current electronic document conventions and processes.
• Participate on teams for process improvement initiatives and review key decisions impacting project timelines with management.

Qualifications

• Bachelor's or Master’s degree in a science-related field with 7+ years’ experience in the pharmaceutical industry.
• Understanding of clinical study principles.
• Strong oral and written communication skills.
• Proficiency in analyzing clinical study data, generating reports, and creating presentations, posters, and manuscripts.
• Knowledge of complex scientific analyses, business-related procedures, and project leadership.
• Experience supporting clinical research, drug development, and/or therapeutic area operations.
• Proven track record of successful projects.
• Attention to detail and ability to produce high-quality work.
• Ability to use resources effectively to complete tasks and meet timelines.
• Independent expertise/experience analyzing clinical study/statistical data using available software.

Education

• Bachelors/Master’s degree in Science related to Field

Additional Requirements

• Hybrid opportunity requiring onsite presence 3x/week in the Lake County, IL office.