Jonathan Lopez
Rosenberg,TX
Summary
Dynamic leader with a proven track record at Edwards Lifesciences and Applied Medical Resources, adept in research methodology and team management. Spearheaded medical writing projects, enhancing team retention and streamlining regulatory compliance. Excelled in data analysis and mentoring, significantly impacting revenue and operational efficiency.
Overview
11
11
years of professional experience
Work History
Manager, Medical Writer
Edwards Lifesciences
Irvine, CA
11.2021 - Current
- Plan, develop, and lead the completion of complex medical writing projects in a fast-paced environment, with accountability for successful completion within the scope of project deliverables, including negotiating timelines and resolving project-related issues with cross-functional partners (e.g., Regulatory Affairs, Quality, Clinical Project Managers, Clinical Data Management, Biostatistics, etc.).
- Act as a technical expert to key stakeholders to develop and lead the implementation of corporate, business unit, and departmental process updates and improvements (e.g., MDR, compliance, etc.).
- Provide direction and guidance for smaller projects to execute medical writing projects and/or initiatives.
- Provide mentoring and knowledge transfer for the Medical Writing team members.
- Act as a representative in core team meetings for the development of reporting plans and regulatory submissions (U.S. and international) for clinical studies.
- Created and aided in the implementation of a team member retention plan to improve team member retention. Team member retention has doubled, and continues to increase.
- Lead the entire department during my upper management maternity leave, ensuring team members felt supported and empowered during this time of transition. Completed this transition successfully while maintaining team morale and ensuring department tasks were completed on time.
- Successfully performed resource planning, performance reviews, and created succession plans to ensure the continued success of the team. Recruited and onboarded team members, ensuring smooth transitions and projects timelines were completed on scheduled.
Manager, Clinical Writer and Processes
Applied Medical Resources
Rancho Santa Margarita, CA
10.2013 - 11.2021
- Determined the company's strategic objectives and policies for the creation of the Clinical Writing team at Applied Medical.
- Created the Clinical Writing team's growth structure, yearly budget analysis, and daily operations to ensure productivity for Applied Medical Resources.
- Created and monitored the progress toward achieving the objectives and policies of the Clinical Writing team.
- Performed a regulatory gap analysis to ensure that Standard Operating Procedures (SOPs) were following new regulations.
- Managed several high-priority initiatives for Applied Medical, ensuring products are available according to executive staff timelines, ensuring over $1,000,000 in revenue.
- Managed and led the development and completion of scientific protocols and reports, including, but not limited to, Clinical Evaluations (per MDD and MDR) and Post Market Clinical Feedback, as part of design validation for medical devices to support product registrations internationally.
- Generated protocols and reports using a well-defined scientific/research methodology.
- Conducted scientific literature reviews and compiled reports, such as annual literature updates and periodic safety updates, to provide to global regulatory agencies.
- Collaborated with cross-functional teams, such as Regulatory Affairs, Quality Systems, Engineering, and the Branding team, to develop new and insightful analytics and data visualization concepts to address unique problems in clinical research.
- Created and maintained standard operating procedures, and work instructions for the preparation and maintenance of compliant medical writing deliverables.
- Managed timelines and communicated with team members to maintain awareness of expectations, milestones, and deliverables.
Manager, Material Management/Planner
Applied Medical Resources
Rancho Santa Margarita, CA
10.2013 - 11.2021
- Created, implemented, and maintained a Product Configuration Management (PCM) program at Applied Medical, saving the company over $1,000,000 in inventory yearly.
- Managed a team of supply chain professionals and oversaw all aspects of the Supply Chain for the Business Unit, delivering status reports, acting with a sense of urgency in response to crucial requirements, and applying supply chain knowledge and experience to successfully navigate high-paced and high-level expectations.
- Worked with the Engineering and Clinical Development department to manage project timelines for new and changing products.
- Collaborated with the Engineering department to determine the most cost-effective, and efficient methods for implementing their project.
- Performed ad hoc analysis using SAP and MS Excel.
- Created and established statistical forecast methods such as exponential smoothing, regression analysis, and time series analysis to reduce Applied Medical overhead costs and improve logistic planning.
- Managed and coordinated the planning for multiple product lines based on ERP/MRP requirements.
- Created and maintained production floor schedules, and worked with manufacturing plants to ensure on-time delivery of products.
- Worked with Strategic Procurement to coordinate with vendors on raw materials availability and shipment.
Education
Master of Science - Applied Statistics
California State University of Long Beach
Long Beach, CA05.2022
Bachelor of Science - Applied Mathematics
California State Polytechnic University Pomona
Pomona, CA06.2013
Skills
- Research methodology
- Data analysis
- CEP CER, PMCF Report/Plan Design
- Statistical analysis and programming (MATLAB, Mathematica, Minitab, C, Python, and R)
- Business administration
- Team member management, onboarding, coaching, and mentoring
- Inventory management
- Decision-making
- Schedule preparation
- Verbal and written communication
- Performance management
- Regulatory compliance and policy implementation
- Resource allocation
References
Available Upon Request
Timeline
Manager, Medical Writer
Edwards Lifesciences
11.2021 - Current
Manager, Clinical Writer and Processes
Applied Medical Resources
10.2013 - 11.2021
Manager, Material Management/Planner
Applied Medical Resources
10.2013 - 11.2021
Master of Science - Applied Statistics
California State University of Long Beach
Bachelor of Science - Applied Mathematics
California State Polytechnic University Pomona