Director, Global Nonclinical Writing and Submissions at Johnson & Johnson

Beerse, Flanders, Belgium

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Healthcare, BiotechnologyIndustries

Requirements

A minimum of a Master’s degree in Biomedical Sciences, Toxicology, Pharmacology, or a related discipline is required. Advanced degree (PharmD, Ph.D. or equivalent) in Biomedical Sciences, Toxicology, Pharmacology, or a related discipline is preferred
A minimum of 10 years of relevant experience in nonclinical writing and submissions supporting diverse modalities and therapeutic areas is required
A minimum of 4 years of direct people management experience is required
Strong knowledge of nonclinical drug development

Responsibilities

Lead and mentor the nonclinical writing team, including internal and contracted writers, to meet pipeline goals with timely and high-quality deliverables (e.g., Investigator’s Brochures, IND/CTA/NDA nonclinical modules, briefing books, health authority responses) across all programs and development phases
Review documents prepared by writers and ensure adherence to standards, quality, and strong positioning of key messages and risk assessment
Maintain awareness of global submissions landscape and ensure nonclinical submissions strategy evolves to produce state-of-the-art, compliant deliverables
Ensure consistent support and implementation of best practices across portfolio and maintain adherence to standard operating procedures and regulatory requirements in partnership with nonclinical, statistical, clinical, regulatory, and quality colleagues
Collaborate effectively with leaders across PSTS and Johnson & Johnson Research and Development to ensure appropriate readiness for submissions within the portfolio from pre-portfolio to post-registration phases
Manage timelines and resources; ensure early identification and timely communication of submissions-related issues and develop contingency plans proactively to address issues

Skills

Nonclinical Writing

Regulatory Submissions

Preclinical Sciences

Safety Assessment

Document Management

Global Regulatory Affairs

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

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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