Senior Medical Writer

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works Remote for our Structural Heart division.  

Summary: Responsible for writing and editing technical documents including requirements documents, specifications, design history files, verification and validation protocols, etc. Constructs or secures the necessary analyses of metrics including quality system linkage and recommendations utilizing statistical methods and database tools available. Provide awareness of data anomalies and performance contrary to goal objectives to management.

What You’ll Work On

• Reviews Design Control documentation to assess compliance to processes and procedures and works with teams to address and correct deficiencies.

• Participates in product/process improvement, troubleshooting, complaint handling, and customer support.

• Technical Documentation Management: Maintain and update Non-conformance Reports (GQMS),Defect Tracking records, and Equipment Tracking records.

• Technical Writing: Write and edit technical documents including requirements documents, specifications, verification and validation documents, Failure Modes and Effects Analysis (FMEA) documents, Design Planning documents, Design Review records. etc.

• Convert relevant product data and information into a form that meets Quality and submission requirements.

• Review, circulate, edit, assemble, inspect and duplicate reports and documentation.

• Data Collection and Analysis: Collect data from functional areas.

• Provide management with reports highlighting data anomalies and performance contrary to goal objectives from review of the field and factory data and metrics published to determine instrument reliability and effectiveness of changes.

• Secure or construct an analysis of the metrics, synthesize the individual analyses into a global perspective by reviewing across- measures and looking for quality system linkages.

• Evaluate, develop, and validate spreadsheets and database infrastructure as needed to support site metrics collection, analysis, and reporting.

• Provide support for internal and external audits of metric and data analysis reports.

• Utilize Electronic Product Data Management (EPDM) system to query, hand-in, view and print technical documentation.

• The documents written and managed will be used throughout the product life cycle for on-market and future products.

• Data generated in the reports will be used to report status and issues to management for review and action.

• Accuracy of data and solid, well structured analyses is critical.

• Summaries and conclusions generated by this individual play a critical role in management decisions relative to the business processes and quality systems.

• The output provided by the incumbent/candidate is subject to external audit (e.g. FDA,ISO). The lack of accuracy and timeliness will impact the Quality system at