Clinical Registry Administrator at Johnson & Johnson

Leiden, South Holland, Netherlands

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Pharmaceuticals, MedTechIndustries

Requirements

A bachelor’s degree in a scientific, technology or healthcare discipline, or equivalent experience
At least 2 years of relevant pharmaceutical/scientific experience in a related discipline e.g. medical writing, data management, biostatistics, clinical programming
General understanding of at least one of the following: regulatory clinical trial disclosure requirements, translation of scientific content for a lay audience, anonymization of clinical data and documents, data sharing
Strong written and verbal communications skills
Good organizational and management skills, and the ability to balance multiple responsibilities and work under tight time constraints
Demonstrated proficiency in the use of relevant systems, tools, and processes

Responsibilities

Helps establish and implement programs and initiatives for the Clinical Data Transparency area, under general supervision
Contributes to projects, programs, or processes for the Clinical Data Transparency area
Participates in all aspects of Clinical Data Transparency including compliance to regulatory policies and privacy regulations
Ensures that any data quality issues are identified and resolved
Coaches junior colleagues in techniques, processes, and responsibilities
Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team
Submits approved documents and content to registries worldwide, either directly such as for clinicaltrials.gov or the EU clinical trial register, or indirectly by providing to the local operating company staff for subsequent submissions to local registries
Tracks, reports and documents disclosure records and associated documents in tools and systems used by the Clinical Registry Group (CRG)
Plans, routes and follows-up disclosure documents with business partners, external partners and local operating companies, ensuring timely and compliant delivery of these documents
Assists business partners, external partners and local operating companies in maintaining accurate and correct (source) data, relevant to the disclosure process
Ensures timely resolution of planning issues to ensure compliant delivery of the disclosure planning

Skills

Data Analytics

Data Governance

Clinical Data Transparency

Data Quality

Regulatory Compliance

Privacy Regulations

Document Anonymization

Clinical Registries

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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