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Senior Specialist Clinical Product Performance

5+ years
$95,000.00 – $190,000.00
10 Dec. 5, 2024
Job Description
Job Type: Full Time Education: RN/RT/B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Here's a summary of the Sr. Specialist Clinical Product Performance position at Abbott:


Organization:

Abbott


Position Overview

Abbott is seeking a Sr. Specialist Clinical Product Performance for their Cardiac Rhythm Technologies division. The position will be based in Temecula, CA or Santa Clara, CA and will involve supporting clinical product performance, focusing on post-market product performance, clinical studies, and ensuring product safety and quality.


Key Responsibilities

  • Product Performance & Safety: Oversee on-market products and clinical trial performance. Evaluate post-market clinical data and customer complaints, identifying product performance or safety risks.
  • Clinical Oversight: Lead efforts in monitoring and managing product safety data (e.g., complaints, MDRs), ensuring compliance with regulatory standards.
  • Regulatory & Compliance Reporting: Coordinate with internal teams to report adverse events, complaints, and regulatory issues. Provide the necessary information for regulatory submissions and investigations.
  • Collaboration & Communication: Work cross-functionally with teams including Compliance, Clinical Science, Regulatory Affairs, Medical Affairs, and Commercial organizations to ensure ongoing product safety and performance.
  • Risk Assessment & Mitigation: Identify and assess risks, plan mitigation strategies, and ensure compliance with relevant regulations and internal controls.
  • Medical and Scientific Support: Provide accurate, balanced, and timely medical device information and support clinical product inquiries related to Abbott Vascular products.

Required Qualifications

  • Education: Bachelor’s Degree in Pharmacy, Nursing, RT, Life Science, or a related health field (or equivalent experience).
  • Experience: Minimum of 5 years of relevant experience in clinical or quality-related roles. A background in cardiology, cardiac surgery, or vascular medicine/surgery is preferred.
  • Clinical/Medical Background: Experience in clinical environments such as medical clinics, nursing, or clinical laboratories.

Preferred Qualifications

  • Cath Lab Experience: Highly preferred to have RN or RT background with Cath Lab experience.
  • Cross-Functional Collaboration: Ability to work across diverse functions and prioritize work in alignment with business needs.
  • Project Management: Strong skills in managing projects across multiple functions, with a preference for experience in cross-division enterprise models.
  • Strong Communication: Excellent verbal and written communication skills, with the ability to work in a fast-paced, changing environment.
  • Travel Requirements: Ability to travel up to 10%, including internationally.

Salary Range

  • Base Pay: $95,000.00 – $190,000.00 annually (may vary by location).

Benefits

  • Health Investment Plan (HIP) PPO: Free medical coverage for employees who complete a wellness assessment.
  • Retirement Savings Plan: High employer contribution.
  • Tuition Reimbursement and Education Benefits: Including the Freedom 2 Save student debt program and FreeU education benefit.
  • Other Benefits: Abbott offers comprehensive health and wellness benefits for employees and their families.

Company Overview

Abbott is a global healthcare leader that provides innovative medical products across a range of sectors, including diagnostics, medical devices, nutritionals, and branded generic medicines. The company is dedicated to helping people live healthier lives, with a strong focus on heart health and vascular technologies.


Abbott offers a fantastic opportunity for professionals in the clinical product performance space to make a significant impact on global health, while enjoying a rewarding and dynamic work environment.