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J&J Family of Companies Director, Safety Analysis Scientist (SAS), Neuroscience Therapeutic Area Lead - Titusville, NJ in Titusville, New Jersey

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.

Janssen Research & Development discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.

We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.

The Director, Safety Analysis Scientist (SAS) Therapeutic Area Lead (TAL) (Titusville, NJ) will be responsible for oversight of scientific safety analyses and evaluations, which are required for regulatory compliance and to aid in safety-related decisions for marketed products and products in development. The TAL will manage a group of scientists who support product Safety Management Teams (SMTs) and work in close collaboration with other safety partners to determine a product’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. The TAL will partner with the Therapeutic Area Safety Head (TASH) and other functions within and outside of Global Safety Strategy & Risk Management (GSSRM) to oversee the strategic messaging and safety profile of company products provided in all deliverables. The TAL will mentor and train their staff to e nsure accurate and timely analyses and well written assessments of safety data for both scheduled aggregate and ad hoc safety reports, as well as contributing to other function’s deliverables as appropriate. The position will be a rotational member of the GSSRM leadership team and will include direct reports.

Principal Responsibilities

Manage the team’s resource needs and lead (direct, train, motivate, evaluate) the scientific personnel to:

  • Develop strong product knowledge.

  • Provide proactive surveillance of assigned product(s).

  • Demonstrate leadership in the SMT.

  • Support the Medical Safety Officer (MSO).

  • Set the safety analysis strategy and conduct strong data analysis.

  • Write clear and concise safety evaluations.

  • Lead ad hoc report and Health Hazard Evaluation (HHE) development.

  • Articulate the impact and medical importance of the analysis.

  • Lead safety data review meetings.

  • Adhere to policies, procedure, and regulations.

  • Collaborate with other safety leaders to ensure high quality safety reports and to guide decision making. Partner with GSSRM leadership to enable the scientific analysis and reporting responsibilities of the group to maintain regulatory compliance and produce high quality safety evaluations.

  • Oversee the safety data review process to evaluate safety data proactively and form a safety position across Global Medical Safety (GMS) which can be leveraged for aggregate safety reports.

  • Support PV audits and inspections.

    The primary decision-making responsibility centers around applying leadership and a thorough understanding of safety data analysis and interpretation, international pharmacovigilance regulations, and company procedures. The Director will function with a high level of independence and must be prepared to represent the function and make decisions about the appropriate course of action to take. In addition, the Director will need to understand stakeholder/customer needs, be able to build alliances, and influence other groups.

    This position reports into the TASH, Global Safety Strategy & Risk Management and works closely with many groups including GSSRM SLT, Medical Affairs, Global Regulatory Affairs, Clinical, and business partners. Specific roles may include Global Regulatory Leader, Compound Development Team Leader, TASH, PV Systems Head, Clinical Leader/Development Head.

Qualifications

EDUCATION & EXPERIENCE REQUIREMENTS:

  • Scientific/health care related degree (Advanced degree preferred, Bachelor’s degree required).

  • At least 9 years of experience in Pharmacovigilance, Aggregate Reporting, or comparable regulated environment with leadership in a multi-function organization preferred.

  • At least 6 years of experience leading in a global organization preferred.

  • People management experience preferred.

    Required Skills:

  • Knowledge of global regulatory framework for aggregate safety reports.

  • Experience in developing aggregate safety reports (e.g., PBRER).

  • Working knowledge of medical concepts and familiarity with safety activities in drug development and post marketing and global safety health authority requirements.

  • Ability to understand and analyze complex medical-scientific data from a broad range of sources.

  • Ability to interpret and present complex data to determine benefit-risk impact.

  • Excellent verbal and written communication skills.

  • Ability to effectively interact with stakeholders, including business partners.

  • Ability to manage/lead in a matrix environment, proven leadership skills.

  • Ability to plan work to meet deadlines and effectively handle multiple priorities.

  • Proficiency in Microsoft applications (e.g. Word, Excel, and PowerPoint).

Primary Location

United States-New Jersey-Titusville-1125 Trenton Harbourton Road

Organization

Janssen Research & Development, LLC (6084)

Job Function

R&D

Requisition ID

2105935585W

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