Associate Director, Safety Analysis Scientist

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

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:

About Innovative Medicine

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 an Associate Director, Safety Analysis Scientist to be located in Horsham, PA; Raritan, NJ; or Titusville, NJ.

Purpose: The Associate Director (AD), Safety Analysis Scientist (SAS) provides scientific expertise and leads the safety assessment of assigned products. 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. They 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 will quickly build alliances and be able to independently influence other safety partners to shape strong decisions/outcomes.
 

You will be responsible for:

• Leading safety evaluations including strategy discussions, collaborating with Therapeutic Area Safety Head (TASH)/MSO and other partners as necessary, data retrieval, data analysis, report writing, and report revision.
   
• Ensuring high quality safety evaluations and reports with minimal comments from partners and minimal revisions required.
   
• Providing input and review of key regulatory or clinical documents as appropriate.
   
• Demonstrating leadership in the SMT and support the MSO.
   
• Supporting SMT activities (e.g., preparing and presenting data, compiling meeting minutes, updating signal tracking information).
   
• Leading proactive safety data reviews, if applicable and form a safety position across Global Medical Safety (GMS) which can be used for aggregate safety reports.
   
• Providing support for Health Authority interactions regarding safety and risk management, both written and verbal.
   
• Assuming responsibility for novel projects, bringing value and innovation without defined processes. May seek guidance from Directors (i.e., SAS TAL) for complex projects.
   
• Leading cross-functional training of relevant partners.
   
• Acting as product or process Subject Matter Expert (SME) for audits/inspections.
   
• Participating in, or leading, department and/or cross-functional initiatives.
   
• Exploring innovative ways of presenting