Medical & Technical Writer, Sci Ops - JJMT Electrophysiology at Johnson & Johnson

Irvine, California, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, MedTech, Medical Devices, CardiovascularIndustries

Requirements

Passion for improving cardiovascular health, particularly in electrophysiology, heart recovery, stroke, heart failure, and atrial fibrillation
Ability to work in a hybrid schedule (2-3 days per week on-site) in Irvine, California or Raritan, New Jersey

Responsibilities

Write Scientific Operations medical and technical documentation including Clinical Evaluation Plan (CEP), Clinical Evaluation Report (CER), Literature Review Protocol (LRP), Literature Review Report (LRR), Summary of Safety and Clinical Performance (SSCP), Periodic Safety Updates Report (PSUR) documents, and other medical and technical assessments based on available data inputs
Respond to inquiries from Health Authorities and Notified Body as it pertains to data and information presented in the documents written
Track and trend inquiries and responses to improve processes and increase speed to market; translate insights into viable processes and solutions that create value
Ensure the Scientific Operations deliverables are linked to appropriate Quality Systems and Regulatory documents (e.g., Risk Management, PMS) to ensure information is consistent and accessible where needed
Communicate to drive alignment in strategy across different functions including Medical Affairs, Clinical Research, Quality, R&D, and Regulatory Affairs
Participate in workshops and projects/initiatives to help define process improvements
Support audits and inspections pertaining to Scientific Operations processes and reports

Skills

Key technologies and capabilities for this role

Medical WritingTechnical WritingClinical OperationsRegulatory WritingScientific WritingMedTechElectrophysiology

Questions & Answers

Common questions about this position

What is the work arrangement for this role?

This role can be located in Irvine, California or Raritan, NJ with a hybrid working schedule of 2-3 days per week on-site.

What are the main responsibilities of this position?

The role involves leading the authoring of Clinical Evaluations (CERs), State of the Art Assessments (SOA), Literature Reviews, Summaries of Safety and Clinical Performance (SSCP), and Periodic Safety Updates (PSUR) for the MedTech Electrophysiology business unit, along with providing input to related functions for regulatory and medical documents.

What is the salary range for this position?

This information is not specified in the job description.

What does the company culture emphasize at Johnson & Johnson?

The company emphasizes healthcare innovation to prevent, treat, and cure complex diseases with smarter, less invasive, and personalized solutions, fueled by innovation at the intersection of biology and technology.

What makes a strong candidate for this Medical & Technical Writer role?

A strong candidate would have expertise in authoring complex medical and technical documents such as CERs, SOA, Literature Reviews, SSCP, and PSUR, along with experience supporting regulatory submissions in a MedTech or clinical operations 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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