Senior Analyst, Regulatory Affairs (Global Planning & Execution) - MedTech Surgery, Inc. - Johnson and Johnson
Raritan, NJ 08869
About the Job
About Johnson & Johnson
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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/.
The Senior Analyst, Regulatory Affairs Global Planning and Execution is a key partner in the acceleration of global market access. They are responsible for leading the establishment, implementation, and execution of methods for planning and coordinating MedTech Surgery product submissions globally and support their execution by efficiently planning and facilitating the fulfilment of document and information in compliance with corporate policies and strategies. They perform capacity planning and bring awareness to resource constraints to meet business submission plans. Analyze performance metrics and implement action and plans to improve performance. Interprets new and changing government regulations to ensure compliance with regulatory/government standards. This role will involve successful collaboration across MedTech Surgery RA Platform and Regional RA Teams.
Key Responsibilities :
• Experienced individual contributor, who operates with minimal direction and in accordance with all applicable federal, state, and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
• Oversee a high-volume, fast-paced process
• Accelerate market access by supporting regulatory strategies and aligning on regulatory submissions requirements, and execution pathway to ensure timely product approvals.
• Strongly collaborate with MedTech Surgery RA Platform and Regional RA to develop a monthly international submission plan and yearly submission forecast
• Analyze the monthly plan and yearly forecast to evaluate resource capacity, facilitate and lead conversation between RA Teams to align priorities, identify resource constraints and set up plans based on priorities and resource capacity.
• Communicate to upper management conflicting priorities, bring awareness of resource constraints for decision making.
• Identify practices that stand in the way of achieving results and lead process improvements or total process transformation to achieve efficiency and alignment with business priorities.
• Handle large volume of RA data, analyze, develop, build reports and performance metrics. Use digital solutions for the management, reporting and visualization of data.
• Assists in preparing regulatory submissions documents required for new and existing product approvals and registrations globally.
• Ability to articulate country requirements to multiple audiences and to translate regulations into clear data requirements to support registrations.
• Collaborate with Reg Ops, MedTech and vendors in RA process development and improvements.
• Mentors internal and external resources on Surgery RA processes and procedures to ensure all regulatory requirements are met throughout the process.
• Mentors more junior colleagues in on techniques, processes, and responsibilities.
• Understands and applies Johnson & Johnson's Credo and Leadership Imperatives in day-to-day interactions with team. Required Qualifications :
• Minimum of a Bachelors Degree required, Advanced Degree strongly preferred . Science, Pharmacology, Medical-Engineering or Engineering, or equivalent education
• Minimum 6 years' experience ( 4 with Advanced Degree ) in Global Regulatory Affairs/Quality/Compliance or Manufacturing in Medical Device Industry or medical field .
• Strong verbal and written communication skills, proficient in written and spoken English
• Result oriented with a consistent record of thinking creatively, crafting strategic solutions to problems with impactful business results and an eagerness to learn.
• Strong proficiency with Excel required, Power BI/Tableau highly desired .
• Proven record on taking action on process transformations or leading and implementing process improvements.
• Experience working with high-volume, complex fast-paced processes.
• Experience working with high amount of data, analyzing and creating visualizations to drive action. Experience with regulatory data and regulatory systems is recommended.
• Project Management skills (leading projects, ensuring transparency of roles & responsibilities, crafting an environment of clarity and accountability within the team).
• Analytical and creative problem-solving skills.
• Ability to proactively address challenges.
• Ability to develop and maintain positive working relationships across a broad network of partners.
• Able to work in and direct a team or teams without formal authority (people leadership and influencing).
• Able to independently work in a global and virtual network.
• Able to present to internal and external audiences and drive conversations with a diverse group of partners to consensus.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
The anticipated base pay range for this position is $104,000 to $166,750 based on experience. 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)).
• Employees are eligible for the following time off benefits:
o Vacation - up to 120 hours per calendar year
o Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
o Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
• Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.