Sr Post Market Data Analyst

Job Title: Sr Post Market Data Analyst
Job Location: Acton, MA (Hybrid)
Job Duration: 06 Months

Candidates local to Acton, MA preferred

Description:

• This position is responsible for providing support in making strategic and tactical data-related decisions by analyzing, manipulating, tracking, internally managing, and reporting post-market surveillance data and leading and supporting post-market projects through a methodical approach of planning, executing, and tracking project deliverables from start to finish.
• The Senior Post Market Data Analyst works collaboratively with the Global Product Monitoring leadership team and other functions as needed to address key safety, quality, and compliance questions using the appropriate tools/skills to derive the best answers, to help drive required actions, and ensure project progress and success.
• The Senior Post Market Data Analyst will be expected to provide insight and recommendations based on analysis involving data, systems, and performance. This individual will identify opportunities for improvement within existing processes, partner on the development of reporting tools to support objectives , deliver analysis, track performance and productivity. This individual will provide strategic and tactical support by analyzing, maintaining , and cleansing data from various sources, including TrackWise.
• Additionally, the Senior Post Market Data Analyst may be asked to support post-market compliance by (a) assessing the need for new or revised procedures/instruction s and/or corrections or corrective actions and (b) helping to drive these changes forward ; and (c) leading or supporting non-routine / high-impact requests for additional information (RFAI) related to vigilance .

• Collaborate with cross-functional teams to identify and acquire data sources, refine and prepare data through ingestion, cleanup, and pre-processing scripts with an emphasis on dashboard creation using Power BI.
• Design and develop interactive, user-friendly dashboards within Power BI to visualize and explore data patterns, enabling stakeholders to derive actionable insights.
• Optimize the process for collecting and analyzing data across multiple systems to provide scheduled and ad hoc analysis and reporting to stakeholders.
• Develop and maintain reports and dashboards.
• Extract data and perform detailed data analysis. Produce and deliver reports on a routine basis to support the company's operational initiatives.
• Communicate the results of data analysis in written and verbal form to leadership.
• Support annual product review and generation of draft and finalized PSURs, CSRs, PMCF Evaluation Reports and other inputs/outputs of annual product review.
• Support patient safety review meeting s through data generation, analysis, and action management.
• Responsible for planning and tracking project performance in relation to short- and long-term goals and keeping actions on schedule.
• Aid in the preparation and delivery of status updates to management and other stakeholders.
• Create meeting agenda, coordinate meetings, and drive meeting minutes and actions.
• Adhere to all regulatory agency standards, company quality standards, and corporate policies.
• Perform other duties as required

• Bachelor's Level Degree
• At least 3 + years of demonstrated experience in post-market surveillance, quality assurance, regulatory compliance, data analysis/analytics or data reporting, and/or project management in the medical device and/or life sciences industry.
• Proficiency in Power BI, including data modeling, report creation, and sharing insights.
• Strong organizational skills.
• Ability to analyze problems and develop solutions.
• Ability to effectively communicate both internally and externally.
• Ability to foster teamwork, to work cooperatively and effectively with team members and to influence without authority . Positive, results driven, rational, logical, team player.
• Demonstrated flexibility and ability to function in a fast-paced, growth industry and work environment. Ability to accurately execute multiple tasks and prioritize effectively with high attention to detail and drive for getting results.
• Ability to work independently and on multiple projects against deadlines.
• Flexibility to move between routine operational and project tasks quickly and seamlessly.
• Working knowledge of MS Office products, Outlook, Word, Excel, and PowerPoint and project management software.
• Ability to understand medical/clinical and technical aspects of product.
• Knowledgeable of Medical Device Regulations.

• Advanced MS Excel skills
• Familiarity with Spotfire
• Excellent writing skills.
• Excellent influencing and negotiating skills.
• Ability to rapidly learn and take advantage of new concepts, business models, and technologies.
• Proficiency with Medical Device regulations, particularly as they relate to post-market surveillance , vigilance , complaint handling, and risk management.

Responsibilities:

• Collaborate with cross-functional teams to  identify  and  acquire  data sources,  refine  and prepare data through ingestion, cleanup, and pre-processing scripts with an emphasis on dashboard creation using Power BI.
• Design and develop interactive, user-friendly dashboards within Power BI to visualize and explore data patterns, enabling stakeholders to derive actionable insights.  
• Optimize  the process for collecting and analyzing data across multiple systems to provide scheduled and ad hoc analysis and reporting to stakeholders.  
• Develop and  maintain  reports and dashboards.
• Extract data and perform detailed data analysis. Produce and deliver reports on a routine basis to support the company's operational initiatives.  
• Communicate the results of data analysis in written and verbal form to leadership.  
• Support annual product review and generation of draft and finalized PSURs, CSRs, PMCF Evaluation Reports and other inputs/outputs of  annual product review.  
• Support patient safety review meeting s  through data generation, analysis,  and action management.  
• Responsible for planning and tracking project performance in relation to short- and long-term goals and keeping actions on schedule.  
• Aid in the preparation and delivery of status updates to management and other stakeholders.  
• Create meeting agenda, coordinate meetings,  and  drive  meeting minutes and actions.  
• Adhere to all regulatory agency standards, company quality standards, and corporate policies. 
• Perform other duties as  required