Associate Dir Safety Analysis Scientist

Johnson & Johnson Horsham , PA 19044

Posted 3 weeks ago

Johnson & Johnson is recruiting for an Associate Director (AD) Safety Analysis Scientist (SAS) (1 of 2) located in Horsham, PA, Raritan, NJ, Titusville, NJ, High Wycombe, UK, and Allschwil, Switzerland with consideration for remote.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

The Associate Director (AD) Safety Analysis Scientist (SAS) provides scientific expertise and leads the safety assessment of assigned products. The AD SAS, in partnership with the Medical Safety Officer (MSO), 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 marketed products and products in development.

The AD SAS will support product Safety Management Teams (SMTs) and work in close collaboration with other cross-functional 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, supporting SMT deliverables as required.

The AD SAS will assist the MSO with activities related to the SMT and with contributions to key safety and clinical documents.

The AD SAS will have in-depth product knowledge, will serve as product point of contact, and will provide training to, and oversight of deliverables prepared by, other team members as needed (for complex reports).

The AD SAS will function with a high level of independence, with minimal guidance from the Director, Safety Analysis Scientist (SAS) Therapeutic Area Lead (TAL), be able to link discussions to content, and consistently deliver high quality results with minimal guidance. The AD SAS will quickly build alliances and be able to independently influence other safety partners to shape strong decisions/outcomes.

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 AD SAS will function with a high level of independence and must be able to recognize potential safety issues and escalate as appropriate, think strategically with respect to data interpretation, and understand the nature of adverse drug reactions and complex associations. In addition, the AD SAS will need to understand stakeholder/customer needs, be able to build alliances and influence other groups, have a high level of flexibility and attention to detail, be able to handle a large workload efficiently, and be able to complete safety evaluations and other related functions with a high degree of efficiency.

This position works closely with many groups including Global Safety Strategy & Risk Management (GSSRM), Medical Affairs, Global Regulatory Affairs, Clinical, Compliance, Standards and Analytics, Epidemiology, International Pharmacovigilance, Regulatory Medical Writing, the vendor, and business partners. Specific roles may include Global Regulatory Leader, Compound Development Team Leader, TASH, Clinical Leader/Development Head, Medical Safety Surveillance and Insight Physicians and Staff and Scientists, Data Analytics/GMS Support Desk Staff.

Responsibilities:

  • Lead safety evaluations including strategy discussions, collaborating with Therapeutic Area Safety Head (TASH)/MSO and other stakeholders as necessary, data retrieval, data analysis, report writing, and report revision.

  • Ensure high quality safety evaluations and reports with minimal comments from stakeholders and minimal revisions required.

  • Provide input and review to key regulatory or clinical documents as appropriate.

  • Demonstrate leadership in the SMT and support the MSO.

  • Support SMT activities (e.g. preparing and presenting data, compiling meeting minutes, updating signal tracking information).

  • Lead proactive safety data reviews, if applicable and form a safety position across GMS which can be leveraged for aggregate safety reports.

  • Provide support for Health Authority interactions regarding safety and risk management, both written and verbal.

  • Assume responsibility for novel projects, create value and innovate without defined processes. May seek guidance from Directors (i.e SAS TAL) for complex projects.

  • Lead cross-functional training of relevant stakeholders.

  • Act as product or process Subject Matter Expert (SME) for audits/inspections.

  • Participate in, or lead, department and/or cross-functional initiatives.

  • Explore innovative ways of presenting data, preparing reports, and improving efficiencies within the programs they own.

  • Assist Directors in the creation, review and implementation of controlled documents and other related tools.

  • Management of unscheduled reports within the Aggregate Report Calendar.

  • Management activities within smaller Therapeutic Areas, as applicable.

  • Line-management of contractor positions within the team, as applicable.

  • Act as backup to TAL as needed (e.g., Director SAS TAL is unavailable)

  • Oversight of deliverables by other team members (e.g. complex reports), as needed

Qualifications

  • A minimum of a Bachelor's Degree Required: Healthcare-related or Biomedical Science (11+ years industry experience or equivalent).

  • Advanced Degree Preferred: Healthcare-related or Biomedical Science (8+ years industry experience or equivalent).

  • Medical writing required

  • PV experience preferred

  • Clinical experience preferred

  • 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 disciplines.

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

  • Excellent English verbal and written communication skills.

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

  • Ability to work 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).

  • Ability to independently influence, negotiate and communicate with both internal and external customers.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location

United States-Pennsylvania-Horsham-800/850 Ridgeview Drive

Other Locations

Europe/Middle East/Africa-Switzerland, Europe/Middle East/Africa-United Kingdom, North America-United States-New Jersey-Titusville, North America-United States-New Jersey-Raritan

Organization

Janssen Research & Development, LLC (6084)

Job Function

R&D

Requisition ID

2105964240W

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The Manager SAS, in partnership with the Medical Safety Officer (MSO), 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 marketed products and products in development. The Manager SAS will support product Safety Management Teams (SMTs) and work in close collaboration with other cross-functional 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, supporting SMT deliverables as required. The Manager SAS will assist the MSO with activities related to the SMT and with contributions to key safety and clinical documents. The Manager SAS will have in-depth product knowledge, will serve as product point of contact, and will provide mentoring to, and oversight of deliverables prepared by, other team members as needed (for complex reports). The Manager SAS will function independently, or with moderate guidance from the Director, SAS Therapeutic Area Lead (TAL), be able to link discussions to content, and deliver quality results with minimal guidance. The Manager SAS will build alliances and be able to influence other safety partners to shape decisions/outcomes. 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 Manager SAS will function independently and must be able to recognize potential safety issues and escalate as appropriate, think strategically with respect to data interpretation, and understand the nature of adverse drug reactions and complex associations. In addition, the Manager SAS will need to understand stakeholder/customer needs, be able to build alliances and influence other groups, have a high level of flexibility and attention to detail, be able to handle a large workload efficiently, and be able to complete safety evaluations and other related functions with a moderate degree of efficiency. This position works closely with many groups including Global Safety Strategy & Risk Management, Medical Affairs, Global Regulatory Affairs, Clinical, Compliance, Standards and Analytics, Epidemiology, International Pharmacovigilance, Regulatory Medical Writing, the vendor, and business partners. Specific roles may include Global Regulatory Leader, Compound Development Team Leader, TASH, Clinical Leader/Development Head, Medical Safety Surveillance and Insight Physicians and Staff and Scientists, Data Analytics/GMS Support Desk Staff. Responsibilities: * Lead safety evaluations, including strategy discussions, collaborating with Therapeutic Area Safety Head (TASH)/MSO and other stakeholders as necessary, data retrieval, data analysis, report writing, and report revision. * Ensure high quality safety evaluations and reports with minimal-to-moderate comments from stakeholders and minimal-to-moderate revisions required. * Provide support to AD SASs for novel projects without defined processes. * Provide input and review to key regulatory or clinical documents as appropriate. * Demonstrate leadership in the SMT and support the MSO. * Support SMT activities (e.g. preparing and presenting data, compiling meeting minutes, updating signal tracking information). * Lead proactive safety data reviews, if applicable and form a safety position across GMS which can be leveraged for aggregate safety reports. * Provide support for Health Authority interactions regarding safety and risk management, both written and verbal. * Contribute to cross-functional training of relevant stakeholders. * Mentor other SASs on activities within the role. * Participate in department and/or cross-functional initiatives and explore innovative ways of presenting data, preparing reports, and improving efficiencies. * Assist in the creation, review and implementation of controlled documents and other related tools. * Support audits/inspections. Qualifications * A minimum of a Bachelor's Degree Required: Healthcare-related or Biomedical Science (9+ years industry experience or equivalent). * Advanced Degree Preferred: Healthcare-related or Biomedical Science (6+ years industry experience or equivalent). * Medical writing required * PV experience preferred * Clinical experience preferred * 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 English verbal and written communication skills. * Ability to effectively interact with stakeholders, including business partners. * Ability to work 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). * Ability to influence, negotiate and communicate with both internal and external customers. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Primary Location United States-Pennsylvania-Horsham-800/850 Ridgeview Drive Other Locations North America-United States-New Jersey-Raritan, North America-United States-New Jersey-Titusville, Europe/Middle East/Africa-United Kingdom, Europe/Middle East/Africa-Switzerland Organization Janssen Research & Development, LLC (6084) Job Function R&D Requisition ID 2105964228W Johnson & Johnson Horsham PA

Associate Dir Safety Analysis Scientist

Johnson & Johnson