Sr. Specialist, Process & Governance Lead at Johnson & Johnson

Raritan, New Jersey, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Pharmaceuticals, MedTechIndustries

Requirements

Expertise in clinical trial risk management and quality frameworks
Strong skills in business process ownership, continual improvement, and process optimization
Proficiency in performance monitoring, data analysis, and KPI/metrics development
Experience in data visualization and creating digital dashboards
Leadership capabilities, including chairing governance forums and Serious Breach assessments
Excellent collaboration skills with stakeholders across RDQ, R&D, IM, and MedTech
Ability to model executive presence, preparedness, confidence, and assertiveness in meetings

Responsibilities

Serve as Business Process Owner (BPO) for Clinical Quality Plan, defining, driving, and enhancing oversight strategies and monitoring for CRM clinical trial risk management framework and Quality Support Services (50% time)
Drive accountability in implementing RDQ clinical trial risk management framework, ensuring effectiveness, compliance, and transparency across therapeutic areas (50% time)
Chair, facilitate, or contribute to Risk Management governance forums, developing, assessing, and reporting performance metrics on quality, efficiency, and risk, identifying strengths and gaps
Monitor adherence to process controls, effectiveness, and risk management requirements aligned with business partners, enterprise standards, and regulations; propose and deliver optimization initiatives in collaboration with CRM and partners
Collaborate with stakeholders to create and monitor digital dashboards for CRM metrics and KPIs to enable data-driven decision making
Lead CRM Governance forums and Serious Breach assessments with appropriate preparedness, executive presence, confidence, and assertiveness for efficient decisions
Partner with RDQ QANA, R&D stakeholders, IM, and MedTech to develop templates, scorecards, and other tools

Skills

Key technologies and capabilities for this role

Process ImprovementGovernanceRisk ManagementOperational ExcellenceQuality ManagementClinical TrialsBusiness Process OwnershipData-Driven Decision MakingComplianceRDQ Framework

Questions & Answers

Common questions about this position

What is the work arrangement for this role?

This is a hybrid position.

What are the main locations for this job?

The job posting locations are Horsham, Pennsylvania; Raritan, New Jersey; and Spring House, Pennsylvania, all in the United States of America.

What are the key responsibilities of this role?

The role involves business process ownership for CRM functions, performance monitoring in risk management governance forums, and driving continual process improvement, with 50% time on implementing the RDQ clinical trial risk management framework and 50% on the Serious Breach pillar.

What is the salary or compensation for this position?

This information is not specified in the job description.

What makes a strong candidate for this role?

Strong candidates should have expertise in clinical quality, process ownership, risk management frameworks, performance monitoring, and continual improvement in a pharmaceutical R&D environment.

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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