Medical Safety Officer (MSO)- Heart Recovery, Interventional Cardiology at Johnson & Johnson

Danvers, Massachusetts, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, MedTech, Medical Devices, PharmaceuticalsIndustries

Requirements

Doctor of Medicine (MD), Doctor of Osteopathy (DO), or equivalent (e.g., MBChB)
Experience in medical safety stewardship for Medical Device (MD) products
Knowledgeable in risk management and subject matter expert in the therapeutic area and patient risk management throughout the product lifecycle
Ability to provide a medically independent voice while collaborating in assessing potential safety signals
Experience as an active member of cross-functional teams, partnering with quality leaders and statistical colleagues

Responsibilities

Provide medical safety stewardship for Medical Device (MD) products, including J&J Vision products as assigned
Execute on the Medical Safety Organization’s strategy, implementing programs and leading in strategic priority areas as defined by the Chief Medical Officer
Build relationships between Medical Affairs, R&D, Quality, Regulatory, Clinical, and Epidemiology for proactive risk management
Evaluate customer/user risk and assess impact of product performance issues on patient safety, balancing reactive and proactive approaches
Engage with R&D, Medical Affairs, and quality engineering as a trusted partner in the patient-centered innovation process
Have primary responsibility for one or more companies within MedTech and J&J Vision
Chair the Safety Management Team (SMT) and oversee safety aspects of devices, including benefit/risk profiles throughout the product lifecycle
Conduct risk assessments, review clinical evaluation reports, develop safety surveillance plans, and provide input on risk management plans and post-market surveillance
Represent medical safety in product reviews, approve safety content for labeling, and oversee clinical study safety deliverables (protocols, safety plans, reports)
Interpret post-marketing safety data, complaints, adverse events, and literature reports; advise on mitigations and safety communications
Collaborate with Medical Affairs, R&D, Quality, Regulatory, and cross-functional teams for proactive risk management and patient safety
Monitor regulatory, market, and scientific trends; interface with customers and health authorities as needed
Act as a subject matter expert in audits, regulatory interactions, and due diligence for acquisitions

Skills

Medical Safety

Product Safety Risk Management

Risk Management

Medical Devices

Interventional Cardiology

Heart Recovery

Regulatory Affairs

Quality Management

Clinical Evaluation

Epidemiology

Post-Market Surveillance

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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