Rems Specialist

Johnson & Johnson Johnson & Johnson · Pharma · Somerset, NJ +4

The REMS Evaluation Specialist will be the subject matter expert for REMS EVALUATION products, providing analytics, building relationships, and seeking business development opportunities to enhance customer service. This role requires in-depth knowledge of operating company policies, FDA/DEA requirements, and Elements to Assure Safe Use per REMS EVALUATION product. Responsibilities include daily operations support, quality assurance through trending and audits, and business development for new product launches and process improvements.

What you'd actually do

  1. The successful candidate will be the Subject Matter Expert (SME) REMS Evaluation process Steps FDA REMS Evaluation Requirements Documentation ETASU Provides training content and continuously provides knowledge transfer to the team.
  2. They will perform routine trending on all customer/order issues and concerns.
  3. This person will function as a Key point person on all new REMS EVALUATION required product support and launches.

Skills

Required

  • Minimum of 5 years of in-depth business knowledge and customer focus
  • In depth knowledge of current ERP systems
  • Adept organizational, verbal and written communication skills
  • Works independently
  • Able to influence without direct reporting responsibility
  • Serves as subject matter expert for the business
  • Advanced problem solving and strong analytical experience
  • Ability to work in a dynamic environment, managing achievement of competing priorities and deadlines

What the JD emphasized

  • in-depth knowledge of each operating company’s policies and procedures
  • in-depth knowledge of FDA/DEA requirements
  • varying Elements to Assure Safe Use per REMS EVALUATION product
  • Subject Matter Expert (SME) REMS Evaluation process Steps FDA REMS Evaluation Requirements Documentation ETASU