Senior Analyst, Regulatory Program Management – Immunology

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.

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):

Belgium R-108825, Ireland R-108828, Netherlands R-108829, Switzerland R-108826, United Kingdom R-108827, United States of America R-104909

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Job Function:

R&D Operations

Job Sub Function:

Clinical Trial Project Management

Job Category:

Professional

All Job Posting Locations:

Allschwil, Basel-Country, Switzerland

Job Description:

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

 

We are searching for the best talent for a Senior Analyst, Regulatory Program Management – Immunology. This position can be located in Spring House, PA; Horsham, PA; Titusville, NJ; Raritan, NJ; Cambridge, MA; La Jolla, CA; Beerse, Belgium; Leiden, Netherlands; Maidenhead, UK; Basel, Switzerland; or Cork, Ireland.

 

Candidates must already have authorization to work in the country of employment. Immigration sponsorship and relocation support are not available for this position. Candidates authorized to work pursuant to a short-term status (e.g., F-1) who require future immigration sponsorship are not eligible.

Purpose:

The Senior Analyst, Regulatory Program Manager (RPM) is an operational leader responsible for driving forward the enhancement and optimized delivery of services provided by the RPM team. The Sr. Analyst, RPM helps to ensure proper visibility to book of work, leads assessment of process and monitors quality to support the success of the RPM department and functions as a change management and implementation leader for new process and system rollout across RPM team.  When assigned to programs, the Sr. Analyst supports the translation and distillation of overall global regulatory strategy to executable plans, ensuring successful coordination of cross-functional team efforts. The RPM serves as the primary project management point of contact to ensure Regulatory functional plans are aligned with compound/program objectives and commitments working closely with the Global Regulatory Leader (GRL) and partners across Global Regulatory Affairs, Project Management, Medical Writing, Clinical and other key functions to ensure confidence, quality, and speed in the delivery of the Johnson & Johnson Innovative Medicine (JJIM) Immunology portfolio. The Sr. Analyst, RPM will have responsibilities supporting regulatory and compound project teams directly as well as working internally within the RPM department to enhance and ensure robustness in critical business processes.

Your will be responsible for:

Serve as key facilitator within the RPM department to assigned service area to help ensure proper visibility to book of work, monitoring quality and process to support the success of the RPM department.

Function as a change management and implementation leader for new process and system rollout across RPM team.

Where assigned, lead operations with Global Regulatory Team (GRT), including activities such as ensuring visibility to and/or management of health authority meeting planning, worldwide submissions, driving processes to optimize global filing and launch strategy, and key deliverable in early and late development stages including consolidation of regulatory strategy, pre- and post-submission activities and preparation for health authority meetings.

Translate regulatory requirements and strategy into an executable plan at a level of detail that allows teams to understand what is critical at any one time, proactively identify and mitigate risks, and exploit meaningful opportunities for acceleration. (e.g., MSP project plan, risk and opportunity playbooks, scenario evaluation and business case development).

Provide strong operational leadership to Regulatory and program teams, providing scenario and visualization support driving rapid and informed decision making, challenging status quo, and fostering impactful innovation.

Support the Global Regulatory Team (GRT) in a manner that fosters and maintains a high-performance team culture, facilitating GRT, Submission Working Group, Rapid Response Team meetings, and similar as required.

Ensure coordination of critical regulatory information and team communications to ensure timely and accurate dissemination of the GRT strategy and operational status throughout the team including co-development partners and/or other external partners, as required.

Lead the operational execution of select marketing applications including clinical variations and Pediatric submissions, partnering to ensure alignment of Regulatory and compound submission strategies, developing clear and detailed plans, ensuring team roles, responsibilities and accountabilities, and positioning teams to proactively mitigate risks and enhance opportunities.

Drive process improvements and embed best practices from across programs, TA’s and functions into supported teams.

Work across functions and organizational boundaries to establish processes and procedures and new innovative methods that improve overall delivery.

Build RPM value proposition through continuous refinement of delivery, prioritizing and focusing on areas of highest impact and opportunity, and actively leading efforts to enable enhanced capabilities and impacts.

As required, work with standard budgeting and forecasting process and reporting tools to build and maintain the regulatory components and health authority budget to an overall coordinated project plan in Planisware.

Support and facilitate activity, resource and cost planning across the R&D project portfolio, as required.

Qualifications / Requirements:

 

Education:

Minimum of a Bachelor’s degree is required

Advanced degree is preferred

Required:

Minimum of 4 years of industry/business experience with at least 2 years of experience in a Pharmaceutical, MedTech or comparable R&D area.

Project management experience leading cross-functional teams in a matrix setting.

High proficiency and demonstrated application of project management standards, planning and visualization tools.

Demonstrated experience conducting business process, scenario, and critical path analysis.

Ability to drive and expedite team decision-making and translate strategy to clear, executable action plans.

Must have excellent verbal and written communication skills.

Must have strong innovative and strategic thinking skills.

Ability to resolve controversy and influence teams without formal authority.

This position will require up to 10% domestic and international travel. 

Preferred:

Experience in strategic planning and development of global regulatory strategy, and cross functional management of global regulatory processes.

Experience working with clinical and/or regulatory teams in the early development space.

Knowledge of global regulations, guidelines and regulatory requirements.

Proficiency in the Veeva platform.

High proficiency with Microsoft Project server and/or online environment.

High proficiency in reporting tools and experience in report development.

Project management and/or process excellence certification.

#LI-Hybrid

Required Skills:

Preferred Skills: