Erin Cheney
Pennsville,NJ
Summary
Experienced Pharmaceutical Operations Project Manager with a proven track record of overseeing projects within a pharmaceutical company's operational functions. Specializing in managing projects related to drug development, manufacturing, supply chain, and other operational areas, with a keen focus on timelines, budgets, and regulatory compliance. Dedicated to ensuring efficiency and compliance in all project endeavors.
Overview
7
7
years of professional experience
Work History
Project Manager- Operations
Clinigen
11.2019 - Current
- Successfully managed multiple projects simultaneously by prioritizing tasks according to urgency, resource availability, and alignment with organizational goals.
- Planned, designed, and scheduled phases for large projects.
- Extensive experience in pharmaceutical distribution.
- Monitored project performance to identify areas of improvement and make adjustments.
- Developed comprehensive project plans with clear timelines, milestones, and budget requirements, ensuring timely delivery of high-quality results.
- Maintained accurate documentation of batch records, equipment logs, inventory reports, ensuring traceability throughout the manufacturing process.
- Skilled in biological packaging and labeling, ensuring stability and preventing degradation, often requiring cold chain storage and enhanced security features.
- Managed risk assessments and implemented mitigation strategies to minimize potential issues during project execution.
Medical Coordinator
ORTHOPEDIC
03.2018 - 03.2019
- Liaison between staff and surgeon
- Client consultations to resolve billing and/or insurance conflicts
- Direct interaction with attorneys to resolve disputes
- Overseeing and verifying proper workers compensation billing and distribution of benefits
- Managing daily administrative tasks
- Developed education materials for patients on various health topics to improve their overall understanding of conditions or treatments involved in their care plan.
- Improved patient satisfaction by promptly addressing concerns, answering questions, and providing clear explanations of treatment plans.
- Coordinated clinical research projects by liaising between investigators, sponsors, and ethics committees, ensuring all necessary documentation was completed accurately and on time.
- Scheduled surgeries, managed pre-certifications and verified insurance coverage.
- Developed and updated policies and procedures, maintaining compliance with guidelines relating to HIPAA, benefits administration and general liability.
Skills
- Expertise in Good Manufacturing Practices (GMP) and current Good Manufacturing Practices (cGMP)
- Logistics coordination for domestic and international shipping
- Extensive experience in international distribution compliant with FDA and DEA regulations
- Strong decision-making skills that enhance problem resolution processes
- Experienced pharmaceutical expert with a strong understanding of Standard Operating Procedures (SOPs)
Timeline
Project Manager- Operations
Clinigen
11.2019 - Current
Medical Coordinator
ORTHOPEDIC
03.2018 - 03.2019
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