Associate Director, Safety Analysis Scientist, Cell Therapy | Bridgewater, NJ

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Learn more at and follow n Research & Development, LLC is part of the Janssen medical Companies. The Associate Director (AD) Safety Analysis Scientist (SAS) provides scientific expertise and leads the safety backssment 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. 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. • Assume responsibility for novel projects, create value and innovate 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. • Lead cross-functional training of relevant stakeholders. • Mentor other SASs on activities within the role. • 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. • Assist 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. • Line-management of contractor positions within the team, as applicable. • Act as backup to TAL as needed• Oversight of deliverables by other team members (e. g. complex reports), as needed. Qualifications • A minimum of a bachelor's degree is required in a healthcare-related or Biomedical Science focus with 13+ years industry experience or equivalent; or an advanced degree with 9+ years industry experience or equivalent is required.

• Medical writing or PV experience is required. • Working knowledge of medical concepts and familiarity with safety activities in drug development and post marketing and global safety health authority requirements is required. • Ability to understand and analyze complex medical-scientific data from a broad range of disciplines is required. • Clinical experience is highly preferred. • Oncology experience is preferred. • Ability to interpret and present complex data to determine benefit-risk impact is required.

• Excellent English verbal and written communication skills is required. • Ability to effectively interact with stakeholders, including business partners is required. • Ability to work in a matrix environment, proven leadership skills is required. • Ability to plan work to meet deadlines and effectively handle multiple priorities is required. • Proficiency in Microsoft Word, Excel, and Power Point• Ability to independently influence, negotiate and communicate with both internal and external customers. The anticipated base pay range for this position in all other U.

S. locations is $135,000 to $232,300. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/ performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Employees are eligible for the following time off benefits: Vacation - up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year Holiday pay, including Floating Holidays - up to 13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year For additional general information on company benefits, please go to: www.

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