100% remote. Candidates sitting in PST timezone preferred. Duration: 1 year to start. Possibility of extension. Purpose:

• Under limited supervision, the Data Analyst (will use the term "Analyst" going forward in this document) is responsible for designing, creating and verifying data reports, metrics and visualizations of post market surveillance and sales data.
• The work product supports management reviews and regulatory submissions, as well as other diverse areas of the business.
• The Analyst is responsible for project management of the reports, including defining and negotiating reporting requirements with various clients.
• The Analyst works in a highly collaborative manner, often educating clients on ways to address their data oriented problems. They document workflow, status, appropriate verification and approvals of reports.
• They also ensuring work product meets the requirements of clients, incorporating learning into future continuous improvement.
• The Analyst uses a wide variety of tools, especially SAC, Business Objects, advanced spreadsheet work and statistical packages.
• Support key business initiatives as required, providing statistical analysis, application design and interactive visualizations of data

Responsibilities:

• Creates complex data reports (ad hoc and validated standard reports) for various internal and external clients. Internal clients include Medical Safety, Post Market Quality, Product Surveillance, R&D and CAPA teams. External clients include health ministries (MOH), FDA and other regulatory bodies. Work supports areas such as regulatory submissions, Signal Detection, CAPA, Risk Management and other clients.
• Performs verification (QC) and documents the verification of reports and responses to regulatory authorities related to post-market data. Provides tracking and status.
• Ensures appropriate sign-off, report verification, distribution, and archival of completed reports and correspondence.
• Collaborates with clients to outline strategies to address regulatory questions or formal "Requests for Information" by researching and preparing reports on safety data for regulatory agencies, etc. Serves as team member (along with Medical Safety, Post Market Surveillance, Regulatory, etc.) in defining and executing requests and mandatory reporting, including both ad-hoc requests and establishing new re-occurring reports.
• Facilitates report request across a variety of functional groups to meet the clients requirements, including collaborating across different functional departments to attain the necessary information.
• Design and runs database queries and collects supporting documentation for report preparation.
• Drafts SOPs, DOPs, presentations and work instructions for departmental practice.

Required:

• SAP Analytics Cloud (SAC) - 4yrs
• SAP Analysis for Office (AO) - 2yrs
• Excel -2 yrs
• SQL - 2 yrs
• TIBCO or Business Objects - 1 yr

Required Skills : Data Analysis Basic Qualification : Additional Skills : Data Analyst Background Check : No Drug Screen : No