Associate Director, Safety Analysis Scientist

Job Function: Product Safety

Job Sub Function: Product Safety Risk Management

Job Category: Scientific/Technology

All Job Posting Locations: Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America

Job Description: Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine We are searching for the best talent for Associate Director, Safety Analysis Scientist. 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 Medical Safety Officer (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. 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 of 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 Global Medical Safety (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 unavailab