Medical Writer II
About The Position
Medical Writer II Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and 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 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists. The Opportunity Our location in Abbott Park (Lake Bluff), Illinois currently has an opportunity for a Medical Writer II. This role serves as medical writing subject matter expert on cross-functional teams responsible for medium risk product submissions (e.g., Class II) with global agencies (e.g., FDA). Helps ensure new/on-market products are cleared/approved. What You’ll Work On Creates/updates technical documents for medium-risk product international regulatory submissions (e.g., IVDR Class B). Creates/updates technical documents for medium-risk product domestic regulatory submissions (e.g., Class II). Prepares associated product labeling and clinical labeling (vial, kit labels), instructions for use and clinical brochures for medium risk products (e.g., IVDR Class Bor US Class II). Completes templated verification and stability records for medium risk products. Creates and updates troubleshooting guides. Interfaces with key stakeholders on tasks (e.g., Regulatory, Technical, Quality, Marketing, GSS, Assay Integration, Medical Affairs, Product Safety). Coordinates all activities related to the tasks above by locating inputs for documents, navigating systems related to international and domestic regulatory submission, labeling, records, and troubleshooting guides, utilizing and proposing updates to templates, tools, and best practices for assigned tasks, and scheduling and running cross-functional team meetings.
Requirements
- Bachelor's Degree in Science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred OR an equivalent combination of education and work experience
- 3 years' experience in Medical Writing or a related field
Responsibilities
- Creates/updates technical documents for medium-risk product international regulatory submissions (e.g., IVDR Class B).
- Creates/updates technical documents for medium-risk product domestic regulatory submissions (e.g., Class II).
- Prepares associated product labeling and clinical labeling (vial, kit labels), instructions for use and clinical brochures for medium risk products (e.g., IVDR Class Bor US Class II).
- Completes templated verification and stability records for medium risk products.
- Creates and updates troubleshooting guides.
- Interfaces with key stakeholders on tasks (e.g., Regulatory, Technical, Quality, Marketing, GSS, Assay Integration, Medical Affairs, Product Safety).
- Coordinates all activities related to the tasks above by locating inputs for documents, navigating systems related to international and domestic regulatory submission, labeling, records, and troubleshooting guides, utilizing and proposing updates to templates, tools, and best practices for assigned tasks, and scheduling and running cross-functional team meetings.
Benefits
- 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 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
