Manager, RA Submissions at Johnson & Johnson

London, England, United Kingdom

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Healthcare, MedTechIndustries

Requirements

University/bachelor’s degree and 6 years of related professional experience, or Masters/PharmD/PhD in combination with 4 years of relevant/related professional experience
In-depth understanding of drug development process
Ability to demonstrate in-depth knowledge of clinical trials regulatory submissions, filings, and processes
Ability to work and lead in a matrix environment
Proven ability to build positive relationships and influence stakeholders across an organization
Proficiency in relevant clinical trials submission-related Health Authority and Industry regulations and guidelines
Proficient use of Regulatory Information Systems
Fluency in English; other languages may be required depending on assignment
Project / submission management proficiencies
Previous experience leading Clinical Trial Submission Team meetings to coordinate the preparation and maintenance of submissions and filings

Responsibilities

Be responsible for the operational management and delivery of global clinical trial regulatory submissions
Create and handle dossier plans/submission packages in line with clinical trial regulatory strategy
Support decision making impacting the quality and timeliness of Clinical Trial Health Authority submissions
Make decisions on clinical trial submission operational strategies for the best project management approach within process/timeline/resource constraints
Lead Clinical Trial Submission Team meetings to coordinate the preparation and maintenance of regulatory submissions and filings
Take a leadership role for the monitoring and efficiency of the submission process and initiate changes within the scope of decision-making authority to minimize inefficiencies and ensure / improve quality
Cultivate effective relationships, maintaining open communication with key partners to ensure priority conflicts, resource issues, and deviations from the plan are identified and resolved
Develop departmental work practices, process enhancements / improvements, and associated training materials
May be responsible for performance and development of direct reports
May lead and/or contribute to special projects and participate in process improvement initiatives

Skills

Regulatory Affairs

Clinical Trial Applications

Regulatory Submissions

Dossier Management

Submission Packages

Project Management

Health Authority Submissions

Clinical Trial Strategy

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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