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Johnson & Johnson

Makes prescription drugs and medical devices

Manager – Local Literature Surveillance

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeNeuss, Germany

About the Job

Requirements

  • A bachelor's degree in Life Sciences, Pharmacy, Healthcare, Business Administration, or a related discipline is required; an advanced degree is preferred.
  • At least 6 years of experience in pharmacovigilance, literature surveillance, medical safety operations, or a related field is required.
  • Strong understanding of local literature surveillance requirements and regulatory expectations across multiple international territories is required.
  • Experience managing outsourced service providers and strategic vendor relationships, including performance oversight, service delivery management, governance, and continuous improvement, is required.
  • Experience working within a complex matrix organization and collaborating across regions, functions, and cultures is required.
  • Project and operational leadership experience, including managing large-scale initiatives, process transformations, and global operating models, is required.
  • Experience managing controlled documents, procedural governance, and quality system documentation, including guidance documents and standards, is required.
  • Experience leading cross-functional initiatives and influencing stakeholders without direct authority is required.
  • Strong analytical, problem-solving, organizational, and decision-making skills, including the ability to manage competing priorities in a complex environment, are required.
  • Excellent written and verbal communication skills, including communicating with senior leaders, vendors, and global stakeholders, are required.
  • Ability to collaborate across multiple time zones and geographically dispersed teams is required.
  • Proficiency in written and verbal English is required.

Responsibilities

  • Lead governance and oversight of outsourced local literature surveillance operations and manage strategic vendor partnerships to ensure compliant, high-quality service delivery, performance target achievement, effective issue resolution, and continuous process improvement.
  • Provide leadership and subject matter expertise in local literature surveillance processes, associated safety systems, and end-to-end operational workflows.
  • Serve as the business owner for local literature surveillance governance, maintaining accountability for controlled documents, policies, procedures, and global standards, including oversight of applicable guidance documents.
  • Build and maintain effective partnerships with cross-functional stakeholders across EMEA, Asia Pacific, and other global regions to ensure alignment, compliance, and operational excellence.
  • Drive standardization, scalability, and continuous improvement across local literature surveillance processes and systems.
  • Use knowledge of Local Medical Safety and related pharmacovigilance processes to support effective oversight, decision-making, and issue management.
  • Support other projects as needed.
  • Build trusted partnerships across functions, geographies, and external organizations.
  • Drive accountability and results through stakeholder engagement and vendor management.
  • Use data and insights to improve operational performance and shape strategy.
  • Lead through complexity and ambiguity while maintaining a focus on quality and execution.
  • Champion innovation, continuous improvement, and scalable solutions that support global pharmacovigilance operations.

Desired Qualifications

  • Experience working in Local Medical Safety.
  • Experience supporting regulatory inspections, audits, CAPA management, and quality systems.
  • Experience leading vendor governance programs and outsourced pharmacovigilance operations.

About the Company

Johnson & Johnson

Makes prescription drugs and medical devices

Johnson & Johnson develops prescription medicines and makes medical devices for hospitals, and unlike most big drugmakers, it runs both businesses under one roof. In 2015, its Darzalex became the first antibody drug approved for multiple myeloma, a blood cancer. Its medicines treat cancer, immune diseases such as psoriasis, and mental illnesses such as depression, and patented drugs bring in most of its sales. Its MedTech unit makes heart pumps, catheters that treat irregular heartbeats, surgical sutures, and Acuvue contact lenses. It was founded in 1886 to make sterile surgical dressings, is based in New Brunswick, New Jersey, and spun off its consumer brands, such as Tylenol and Band-Aid, as Kenvue in 2023.

Company size
10,001+
Company stage
IPO
Headquarters
New Brunswick, NJ
Founded
1886

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