General Submission
Red Cell PartnersSalary not specified
Full Time
Entry Level & New Grad, Mid-level (3 to 4 years), Senior (5 to 8 years), Expert & Leadership (9+ years)
Associate Director, Global Nonclinical Submissions Operations at Johnson & Johnson
Beerse, Flanders, Belgium
Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Healthcare, BiotechnologyIndustries
Requirements
- Minimum of a Master’s degree in Biomedical Sciences, Toxicology, Pharmacology, or a related discipline
- Advanced degree (PharmD, Ph.D. or equivalent) in Biomedical Sciences, Toxicology, Pharmacology, or a related discipline is preferred
- Minimum of 6 years of relevant experience with submissions supporting diverse modalities, geographies, and therapeutic areas
- Minimum of 3 years of direct people management experience
Responsibilities
- Lead and mentor the nonclinical document specialist and SEND teams, including internal and contracted staff, to meet pipeline goals with timely and high-quality deliverables across all programs and development phases
- Provide operational support for nonclinical submissions, including planning and management of timelines and resources, knowledge management of procedures and best practices, chair global submissions team meetings with agenda/minutes/action items/follow up monitoring, and generation of KPIs/metrics
- Implement best practices, drive continuous improvement, and identify efficiencies to enable quickest timelines and engagement in data science initiatives to develop and adopt Artificial Intelligence (AI)/Machine Learning (ML) tools for submissions-related processes
- Ensure consistent document/SEND support across portfolio and maintain adherence to standard operating procedures and regulatory requirements
- Collaborate with cross-functional partners across PSTS and Discovery, Product Development and Supply (DPDS) to ensure appropriate readiness for submissions from pre-portfolio to post-registration phases
- Ensure early identification and timely communication of submissions related issues and develop contingency plans proactively to address issues
Skills
Nonclinical Submissions
Regulatory Operations
Preclinical Development
Submissions Management
Global Operations
People Leadership
Clinical Development
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