Job Details

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 out of our Alameda, CA location in the Diabetes Care division where we're focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We're revolutionizing the way people monitor their glucose levels with our new sensing technology.

The Clinical Scientist II serves as subject matter expert to build and improve the scientific presence in the marketplace and support the marketing strategies on a worldwide basis by providing technical expertise. Helps protect or promote sales of products by reviewing contents for Clinical/Medical and Scientific Affairs functions to ensure claims are substantiated appropriately and consistent with medical terminology and practice.

What You'll Work On

• Review Ad-Promo content for Clinical and Scientific Affairs function. Provides clinical/technical support to Scientific and Medical Affairs to address product related queries.
• Generate literature summaries and technical write-ups for regulatory submissions.
• Support writing papers and presentations for publication in peer-reviewed medical and/or scientific journal of conferences.
• Interfaces with key stakeholders on tasks (e.g., Regulatory, R&D, Quality, Marketing, Medical Affairs).
• Creates/updates technical documents for medium risk product international regulatory submissions (e.g., IVDR Class C/D and/or novel).
• Creates/updates technical documents for medium risk product domestic regulatory submissions (e.g., Class III and/or de novo).
• Prepares associated product labeling and clinical labeling (vial, kit labels), instructions for use and clinical brochures for high risk/high visibility products (e.g., IVDR Class C/D or US Class III, novel products, de novo products).
• Completes templated or untemplated verification and stability records for high risk/high visibility products.
• Creates and updates troubleshooting guides.
• 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, proposing, and making updates to templates, tools, and best practices for assigned tasks; and independently scheduling and running cross-functional team meetings.
• Seeks out solutions and resolves issues independently on tasks, projects, and in cross-functional team meetings.

Required Qualifications

• Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.
• Equivalent combination of education and experience in lieu of a degree.
• 5 years' experience in medical writing or a related field

The base pay for this position is $86,700.00 $173,300.00. In specific locations, the pay range may vary from the range posted.