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Manager, Global Scientific Affairs

1 month ago

Princeton, United States Abbott Laboratories Full time

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.

Abbott Point of Care is a global leader in providing critical medical diagnostic and data management products for rapid blood analysis that are intuitive, reliable, and cost-effective. Our i-STAT System is an advanced, portable diagnostic tool that provides real-time, lab-quality results within minutes to accelerate patient-care decision-making. The i-STAT System has the industry’s most comprehensive menu of tests in a single, with-patient platform, including tests for blood gases, electrolytes, chemistries, coagulation, hematology, glucose, and cardiac markers. By delivering lab-quality results in minutes, our i-STAT System fosters a collaborative, patient-centered environment while driving improved operational performance.

**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.

**The Opportunity**

Our Scientific Affairs Team has an opportunity for a Manager, Global Scientific Affairs based in Princeton, NJ. The Manager, Global Scientific Affairs will be responsible for overall coordination of investigator sponsored studies (ISS) and collaborative studies (CRS) from initiation of study discussions and scientific engagement, oversight of the concept/proposal submission, review & collaboration, start-up to study close-out, including agreement execution, study material shipment, gathering and communicating periodic study updates and, timely execution of study.

This position will involve pre-review of all study concepts/proposals, preparing review and presentation materials for the scientific review committee (SRC) and managing collaborative study protocol versions with APOC and Principal Investigator(s). The Scientific Affairs Manager will also liaise with cross-functional team members including clinical, regulatory, quality, legal, supply chain and will be responsible for managing individual study budgets/milestone payments. He / She will provide product training, study design, protocol and/or workflow development. The Scientific Affairs Manager will also support abstract, poster and manuscript tracking and review for ISS studies and may occasionally support similar study management processes for Collaborative studies.

**What You’ll Work On**
- Responsible for overall coordination and management of Collaborative Studies from concept/proposal submission support, review, collaboration steps, start-up to study close-out, including agreement execution, study material tracking, gathering and communicating periodic study updates, timely execution of study, tracking publication timelines and review, invoice submissions and other activities.
- Tracks and supports study start up activities - essential documents, planning shipments, discussing milestones, finalizing agreements etc
- Performs an initial review of the concept/proposal along with the Investigators’ curriculum vitae.
- Documents all study communication with Investigator and site personnel.
- Works cross-functionally and communicates to internal teams (Regulatory, PMO, R&D) proactively and in a timely manner.
- Acts as an additional resource for technical questions, inquiries and troubleshooting.
- Manages standard response documents and custom responses. Maintains repository for global medical information
- Provides i-STAT system training (when necessary) and related documentation to ISS study site staff, following the approved study protocol and agreement.
- Supports publication plan review and tracking of manuscripts and other related publications concerning ISS/collaborative studies.
- Updates SOPs and documents related to Collaborative Studies.
- Performs continual independent review of medical/scientific literature and competitor's diagnostic devices. Supports updates to the publications repository.
- Critically evaluates medical/scientific lite

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