Manager, Regulatory Business Analyst

Johnson & Johnson•Titusville, NJ

29d

About The Position

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 jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. 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 Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): Raritan, NJ or Titusville, NJ or Horsham, PA - Requisition Number: R-061303 Allschwil, Switzerland - Requisition Number: R-062522 High Wycombe, United Kingdom - Requisition Number: R-062527 Beerse, Belgium or Warsaw, Poland - Requisition Number: R-062533 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. We are searching for the best talent for Manager, Regulatory Business Analyst for either Raritan, NJ or Titusville, NJ or Horsham, PA or Allschwil, Switzerland or High Wycombe, United Kingdom or Beerse, Belgium or Warsaw, Poland. Purpose: The Manager, Regulatory Business Analyst will collaborate with business stakeholders and technical teams by analyzing, evaluating, and translating user requirements to identify and drive optimal solutions aligned with business outcomes. This position requires strong analytic thinking and creative problem-solving skills with the ability to imagine new possibilities, apply modern technologies and communicate effectively to business and technical teams. The incumbent will also be responsible for supporting system training, user acceptance testing, and engaging in continuous research and discovery to identify market trends in our competitive landscape, gather user feedback and proactively assess evolving business requirements.

Requirements

Minimum of a Bachelor’s degree in Computer Science, Engineering, Biochemistry, Biological Sciences, Biology, or related discipline is required
A minimum of 6 years relevant experience in the pharmaceutical, life sciences, or healthcare industry is required
Demonstrated expertise in conducting business process analysis, problem framing, design thinking, and analytic techniques is required
Creative problem-solving skills with a focus on feasibility assessments is required
In-depth knowledge of Regulatory processes and global compliance standards (e.g, FDA, EMA, ICH) and technical solutions (e.g., RIM, Veeva, Calyx, etc.) is required
Aptitude to stay current with industry trends related to solutions and stakeholder needs is required
Proficiency in using agile tools and methodologies (e.g., Kanban, Scrum) is required
Strong understanding of data integrity, compliance and validation is required
Advanced knowledge of analytical tools (e.g., Tableau) is required
Excellent verbal and written communication skills are required
Sense of urgency to deliver results while balancing high-quality outcomes and an astute understanding of what constitutes “good enough.”
Excellent partnerships skills to foster collaboration across organizational boundaries are required
Action-oriented and inquisitive self-starter with ability to learn quickly and challenge status quo to deliver innovative solutions is required
Demonstrated experience leading and managing cross-functional teams is required
Big picture view to problem solving with attention to detail is required
Ability to distill and communicate complex analyses in a clear, effective way to various stakeholders is required
Demonstrates ability to lead with agility, champion a fail-fast and learning culture to enable rapid adaptation and deliver measurable outcomes is required
Thrive in working independently and in a fast-paced, matrixed environment is required
Develop and manage relationships with stakeholders and subject matter experts
Must be able to work independently with minimum supervision to meet tight deadlines, and maintain a positive attitude

Nice To Haves

Master's degree is preferred
Strong ability to understand strategic business context and direction, anticipate needs and consider new possibilities is required
Proven ability to conduct thorough market and competitive analysis, including data interpretation and trend forecasting is preferred
Ability to manage UAT and system validation is preferred
Experience in leading multiple, complex projects from inception to completion is preferred
Experience assessing and evaluating novel technology solutions is preferred
Project management certification or application of methodologies (e.g, Waterfall, Green Belt, Black Belt) is preferred
Proficiency with productivity and collaboration tools (e.g. PowerBI, Power Automate, Generative AI tools, Mural)
Up to 10% travel required on as needed basis.

Responsibilities

Collaborating with business stakeholders and technical teams by analyzing, evaluating, and translating user requirements to drive optional solutions aligned with business outcomes.
Translating user requirements into clear, concise, and accountable documentation including user personas, use cases, journey maps, and process flows.
Developing user-friendly solutions using techniques grounded in agile and design thinking principles to uncover optimal workflows and user experiences with available technologies.
Supporting ongoing enhancements to Regulatory platforms and systems by gathering feedback, assessing change requests, and helping prioritize feature development
Partnering with business product leaders to translate product updates into business outcomes to enhance user experience and adoption
Engaging in continuous discovery to identify new opportunities by gathering user feedback, analyzing market trends, and assessing emerging business needs
Maintaining an understanding of the portfolio of Regulatory technical solutions
Supporting user training, act as an ambassador of digital solutions, and partner with business product leads to ensure smooth launch and adoption.
Collaborating with technical teams and users during UAT, validating business needs are met and identifying defects and/or gaps.
Supporting the design of Regulatory end-to-end processes aligned to the defined business strategy using established GRA Process Office governance, standards, and methodologies.
Supporting the business to establish efficiency, effectiveness, and experience KPIs for processes

Benefits

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 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
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits