Associate Director Safety Analysis Scientist

“Caring for the world… one person at a time” … inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo

Associate Director, Safety Analysis Scientist

Position overview

The role is open due to a new headcount to support a new product in development. The role is accountable for providing scientific expertise and leading the safety assessment of assigned product(s). The Associate Director, Safety Analysis Scientist (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 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.

Tasks & Responsibilities:

• Lead safety evaluations including strategy discussions, collaborating with Therapeutic Area Safety Head/Medical Safety Officer (MSO) and other stakeholders, data retrieval, data analysis, report writing/revision
• Provide input and review to key regulatory and clinical documents as appropriate
• Demonstrate strong leadership in the Safety Management Team and support the MSO
• Support SMT activities (eg, preparing/presenting data, compiling meeting minutes, updating signal tracking information)
• Lead proactive safety data reviews and form a safety position across GMS, which can be leveraged for aggregate safety reports
• Support Health Authority interactions regarding safety and risk management
• Assume responsibility for novel projects, create value and innovate without defined processes
• Support/lead team initiatives

Qualifications

• Healthcare-related or Biomedical Science degree required (Bachelor’s degree required [11+ industry experience, or equivalent]; Advanced degree preferred [8+ industry experience, or equivalent])
• Ability to work in a matrix environment, proven leadership skills
• Medical writing or PV experience required
• Clinical experience preferred
• Strong scientific acumen with the ability to interpret and present complex data to determine benefit-risk impact
• Ability to understand and analyze complex medical-scientific data from a broad range of disciplines

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

Primary Location
Switzerland-Allschwil– Other Locations
United States-New Jersey-Raritan, United States-New Jersey-Titusville, United States-Pennsylvania-Horsham, United Kingdom-England-High Wycombe
Organization
Actelion Pharmaceuticals Ltd (Swiss Confederation) (8542)
Job Function
R&D
Requisition ID
2005859786W