Sr. Specialist, Scientific Operations (Irvine, CA) Johnson and Johnson, MedTech Electrophysiology at Johnson & Johnson

Irvine, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

MedTech, Electrophysiology, HealthcareIndustries

Requirements

Expertise in reviewing Clinical Evaluations (CERs), State of the Art Assessments (SOA), Literature Reviews, Summaries of Safety and Clinical Performance (SSCP), and Periodic Safety Updates (PSUR)
Ability to support interactions with Notified Bodies and Health Authorities, including drafting and aligning on response strategies
Experience leading Scientific Operations activities/projects, including Eudamed Readiness for SSCP and PSURs under EU MDR
Knowledge of Quality Systems and Regulatory documents (e.g., Risk Management, PMS)
Familiarity with MDR regulatory requirements and industry trends/practices

Responsibilities

Support a team of managers and medical writers to strategize, synthesize, and analyze product-related safety and performance data, draft reports, coordinate approvals, and manage submissions to the Notified Body when applicable
Perform technical reviews ensuring the accuracy and compliance of Scientific Operations deliverables including Clinical Evaluation Plan (CEP), Clinical Evaluation Report (CER), Literature Review Protocol (LRP), Literature Review Report (LRR), Summary of Safety and Clinical Performance (SSCP), and Periodic Safety Updates Report (PSUR)
Track and trend Notified Body inquiries within the business unit to identify trends, improve processes, and increase speed to market; translate insights into viable processes and solutions
Ensure Scientific Operations deliverables are linked to appropriate Quality Systems and Regulatory documents (e.g., Risk Management, PMS) for consistency and accessibility
Develop, implement, and manage an effective communication model for Scientific Operations deliverables with cross-functional business partners
Assist in the development of schedules to ensure operating company deliverable timelines are met
Participate in workshops and lead projects/initiatives to define processes globally, stay abreast of MDR regulatory requirements and industry trends, and maintain proactive review of processes for regulatory compliance and efficiency
Support audits and inspections pertaining to Scientific Operations processes and reports
Provide leadership and maintain relationships through partnering, benchmarking, and strategic alliances with cross-functional business partners to drive key business goals

Skills

Clinical Evaluations

CERs

State of the Art Assessments

SOA

Literature Reviews

Summaries of Safety and Clinical Performance

SSCP

Periodic Safety Updates

PSUR

Regulatory Documents

Notified Body Interactions

Health Authority Interactions

Johnson & Johnson

Healthcare products in pharmaceuticals and devices.

About Johnson & Johnson

Johnson & Johnson operates in the healthcare sector with three main areas: pharmaceuticals, medical devices, and consumer health products. In the pharmaceuticals segment, the company develops prescription drugs for various medical conditions such as cancer and infectious diseases. The medical devices segment provides products used in surgeries and other medical procedures, while the consumer health segment offers over-the-counter products, including baby care and personal health items. Johnson & Johnson generates revenue through direct sales and partnerships, and it invests significantly in research and development to create new products that meet the needs of consumers and healthcare providers. The company stands out from competitors by emphasizing diversity, equity, and inclusion in its workplace, fostering an environment where employees can share their perspectives. Its goal is to improve patient outcomes and enhance the overall health and well-being of individuals globally.

New Brunswick, New JerseyHeadquarters

1886Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

J&J faces a class action lawsuit in Australia over ineffective cold and flu medications.

Former J&J executives joining other firms could lead to increased competition.

Ongoing legal battles, like the lawsuit against Cigna, pose financial liabilities for J&J.

Differentiation

J&J operates in three segments: pharmaceuticals, medical devices, and consumer health.

The company invests heavily in R&D for innovative medical solutions and products.

J&J is committed to diversity, equity, and inclusion in its workplace culture.

Upsides

J&J's collaboration with Helsinki University Hospital focuses on value-based healthcare models.

The rise of personalized medicine offers J&J opportunities in targeted therapies.

Increased focus on digital health solutions presents expansion opportunities for J&J.

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