REMS Specialist

Johnson & Johnson • Somerset, NJ

4d • Hybrid

About The Position

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. The REMS Evaluation Specialist is the subject matter expert (SME) for REMS EVALUATION products. The Specialist provides superior key analytics and accelerates growth by building strong and collaborative relationships. The Specialist seeks out new Business Development opportunities to streamline and enhance the Customer Service function. This position will require in-depth knowledge of each operating company’s policies and procedures. This position will require in-depth knowledge of FDA/DEA requirements and the varying Elements to Assure Safe Use per REMS EVALUATION product. Must possess high-level multi-tasking and organizational skills.

Requirements

• A Bachelors degree is 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.

Responsibilities

• Be the Subject Matter Expert (SME) for the REMS Evaluation process steps, FDA REMS Evaluation Requirements, Documentation, and ETASU.
• Provide training content and continuously provide knowledge transfer to the team.
• Become an expert in all systems within the business.
• Support Business Manager processes.
• Perform routine trending on all customer/order issues and concerns.
• Function as a Subject Matter Expert in all REMS Evaluation matters and audits.
• Perform routine tasks in the document management system.
• Run key reports on a daily, weekly, monthly, annual basis.
• Perform necessary analytics and address any concerns.
• Function as a Key point person on all new REMS EVALUATION required product support and launches.
• Develop process improvements and efficiency gains.
• Propose ideas and gain acceptance.
• Implement project plans and projects.
• Communicate findings and lessons learned.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
• Caregiver Leave – 10 days
• Volunteer Leave – 4 days
• Military Spouse Time-Off – 80 hours

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level