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Associate Director, Safety Analysis Scientist

Company: Disability Solutions
Location: New Brunswick
Posted on: July 1, 2024

Job Description:

Johnson & Johnson is recruiting for an Associate Director, Safety Analysis Scientist , located in New Brunswick, NJ. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/. For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges. We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential. At Johnson & Johnson, we all belong. The Associate Director (AD) Safety Analysis Scientist (SAS) provides scientific expertise and leads the safety assessment of assigned assets for Johnson & Johnson Enterprise Innovation. In partnership with the Senior Safety Officer (SSO), is responsible for the preparation of scientific safety analysis and evaluations, which are required for regulatory compliance and to aid in safety-related decisions for assets throughout their lifecycle. Supports product Safety Management Teams (SMTs) and work in close collaboration with other cross-functional and cross-sector partners, including Pharmaceutical and MedTech safety, to determine an asset's safety strategy, complete safety analyses and evaluations, proactively review safety data/lead safety data review meetings and interpret safety information to make a recommendation, supporting SMT deliverables as required. Assists the SSO with activities related to the SMT and with contributions to key safety and clinical documents. Have in-depth asset knowledge, will serve as an asset point of contact, and will provide training to, and oversight of deliverables prepared by, other team members as needed (for complex reports). The candidate will function with a high level of independence, with minimal guidance from the SSO, link discussions to content, and consistently deliver high quality results. The AD SAS will quickly build alliances and be able to independently influence other partners to shape strong safety decisions/outcomes. Key Responsibilities:

  • Lead proactive safety data reviews, if applicable and form a safety position across JJEI which can be leveraged for aggregate safety reports.
  • Support SMT activities (e.g. preparing and presenting data, compiling meeting minutes, updating signal tracking information).
  • Demonstrate leadership in the SMT and support the SSO.
  • Drive safety evaluations including risk-benefit discussions, collaborating with SSO and other stakeholders as necessary, data retrieval, data analysis, report writing, and report revision.
  • Provide input and review to key regulatory or clinical documents as appropriate.
  • Provide support for Health Authority interactions regarding safety and risk management, both written and verbal.
  • Ensure high quality safety evaluations and reports with minimal comments from stakeholders and minimal revisions required.
  • Assume responsibility for novel projects, create value and innovate without defined processes. May seek guidance from senior leadership (i.e SSO, Chief Safety Officer (CSO) ) for complex projects.
  • Act as safety database querying Subject Matter Expert (SME) for audits/inspections.
  • Explore innovative ways of presenting data, preparing reports, and improving efficiencies within the programs they own.
  • Assist SSO and operational leads in the creation, review and implementation of controlled documents and other related tools.
  • Management of unscheduled reports within the Aggregate Report Calendar.

Keywords: Disability Solutions, New Brunswick , Associate Director, Safety Analysis Scientist, Executive , New Brunswick, New Jersey

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