Associate Director Regulatory Process Development

at  Johnson Johnson

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 where 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 REQUIREMENTS:

• Bachelor’s degree in Science, Business, Regulatory Affairs, or a related field, or equivalent by experience.
• Minimum 6 years of experience in pharmaceutical or healthcare industry.
• Knowledge of drug development and regulatory processes.
• Understanding of Business Process Management methodologies.
• Experience in Project Management.
• Analytical skills.
• Excellent communication, presentation, and meeting facilitation skills.
• Ability to work and thrive in a multi-cultural and matrix environment.
  Johnson & Johnson Family of Companies are equal opportunity employers and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
  The anticipated base pay range for this position in all US 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)).

• Support the global regulatory process strategy that aligns with overall business objectives.
• Support the generation and implementation of an E2E process management model across Global Regulatory Affairs (GRA), including connectivity with partner organizations for shared process ownership (e.g., Clinical, Safety, Supply Chain).
• Apply process design methodologies (e.g., Six Sigma, Lean, BPM) to find opportunities for streamlining and standardizing regulatory processes, reducing cycle times, improving overall efficiency, and helping to align overlapping processes across workflows.
• Leads cross-functional teams to implement process development initiatives, create process metrics, and monitor progress against established benchmarks, partnering with RPD Leadership to identify, prioritize, and sequence initiatives.
• Engage in and collaborate with the team of process development experts to support the implementation of process initiatives.
• Partner with J&J colleagues to ensure compatibility and alignment of the process management activities with the business data, the technology solutions, and the compliance framework.
• Support appropriate change management to drive sustainability of the GRA processes.