Senior Medical Writer / Senior Project Manager, Clinical Evaluation

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 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.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• 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.

For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring system, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.

The Opportunity

The function of a Senior Medical Writer/Project Manager supporting our Vascular Clinical Evaluation Products combines understanding of scientific and research methodology, medical device regulations and guidelines, and product knowledge, to support Regulatory Affairs submissions for CE Marking of new devices and maintaining of CE Mark for existing devices in accordance with the European Commission Guidelines on Medical Devices: Clinical Evaluation : A Guide for Manufacturers and Notified Bodies under Directives 93/42/EEC and 90/385/EEC (2016)requirements (MEDDEV 2.7/1 Rev 4) and EU Regulation 2017/745.

The CER Writer/PM is recognized as a subject matter expert for guidelines and regulations regarding the clinical evaluation process and its consequent documents (e.g., CEP, PMS/PMCF Plan, SSCP and PSUR, and CER). As such, this person has oversight of one or more medical writers guiding the development, or update, of CERs and CER-related documents. In addition, the CER Writer/PM will interact cross-functionally with various personnel to identify and obtain relevant documentation and data on safety, performance, adverse events and risk/benefit profile of a device or devices. Moreover, the CER Writer/PM may be requested to contribute to other activities such as risk assessment and management, and review of informational documents like the Instructions for Use. The CER Writer/PM will sit on core team product development, CER-related SOP development and revision, and interact with regulatory agencies’ representatives as needed.

The role of Scientific CER Writer/PM plays a significant part in new product development, as well as in the subsequent evaluation of the safety and performance of a device over its lifecycle. The position reports to the Sr. Manager of Clinical Evaluations Global Regulatory Operations.

What You’ll Work On

• Independently creates and maintains Clinical Evaluation Plans, Clinical Evaluation Reports, and Summary of Safety and Clinical Performance [SSCPs], Regulatory Responses and other related documentation
• Identifies, evaluates and summarizes clinical evidence including data from sources such as clinical investigations, literature, post-market surveillance, risk, and post market clinical evaluations.  Analyzes results in preparation for product applications and submissions.  
• Reviews IFUs, patient guides, Risk Management files, clinical study reports, physician training mat