New Job Regulatory Affairs Data Strategy Sr. Program Lead In New Jersey

Regulatory Affairs Data Strategy Sr. Program Lead

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

Location: US/EU Remote Role

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.

That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are.

Diversity, Equity & Inclusion at Johnson & Johnson means “ YOU Belong”!

Johnson & Johnson – Medical Devices

We are using our breadth, scale, and experience to re-imagine the way healthcare is delivered and to support people live longer, healthier lives. In a radically changing environment, we are making connections across science and technology to combine our own expertise in surgery, orthopaedics, and interventional solutions with the big ideas of others to design and deliver doctor and patient-centric products and solutions. As pioneers, we continually focus on elevating the standard of care – working to expand patient access, improve outcomes, reduce health system costs, and drive value. We create smart, people-centred healthcare to help the patients we serve recover faster and live longer and more vibrantly.

We are in this for life!

The Senior Program Lead, Regulatory Data Strategy develops and implements regulatory strategies and processes to assure effective use of CSS Franchise Regulatory Data :

• Proposing, maintaining, and communicating the CSS Regulatory Data Strategy within the Franchise – whilst disseminating information to support overall Regulatory Data Strategy Alignment across the MedTech Organisation
• Acting as a subject matter expert in field of data as it pertains to Regulatory Affairs
• Candidate location would preferably be in the US or Western Europe/equivalent time zones due to customer interaction.

Purpose of the role

Under general direction and in accordance with all applicable federal, state, and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position will:

• Propose, collaborate, and document regulatory data strategy for CSS and its business units.
• Create and maintain, where needed, processes and procedures required for the generation, maintenance, utilization, and obsolescence of regulatory data.
• Train the organisation, both regulatory affairs and other cross-functional partners on subjects relating to regulatory data and associated procedures
• Act as a central point of contact on behalf of the franchise for all companywide projects that impact regulatory data.
• Support alignment and coordination between projects which impact regulatory data in the interest of maintain compliance, increasing efficiencies, maintaining data accuracy, and reducing duplicative efforts.
• Consult with collaborators, obtaining inputs and consensus views from across the franchise on the adaptation and development of strategy, procedures and systems relating to regulatory data (business requirements collection)
• Provide input to lobbying and governance activities, both internally and externally in relation to the topic of regulatory data (this may include trade associate representation and review and feedback on draft regulations and guidance)
• Progressing the organisation’s readiness for the passage of regulatory data to the EUDAMED system
• Representing Regulatory needs as business requirements in the development of IT systems and solutions
• Provide guidance and instruction to peers as required to support the execution of existing and future regulatory data procedures and processes.

QUALIFICATIONS

• Bachelor's Degree at minimum within a technical related subject area or comparable education pathway is required.
• Minimum 8 years relevant / regulated industry experience is required.
• Previous experience with medical devices and knowledge in IT environment/applications or IT affinity is strongly preferred.
• Data science or data management or project management course/training/studies
• Experience on data requirements and modelling related to regulations.
• Understands business process design, process improvement methodology, training techniques and has ability to make sophisticated processes simple.
• Education or certificate in project management methodologies e.g., waterfall, agile scrum etc. recommended.
• Knowledge of regulatory requirements in the EU and US, and ability to translate regulations into clear data requirements.
• Ability to work optimally in a structured organization.
• Creative thinking and ability to partner and influence collaborators.
• Able to establish partnerships with regional and Franchise colleagues. Strong communication, influencing and presentation skills.
• Excellent written and verbal communications skills in English (required)
• Location preferred in NW as most of the role is working in US/EU Western time zones.

What type of mark will YOU make?

By joining our company, you will find boundless opportunities to craft your path & amplify your impact inside & outside our walls. And with our commitment to be the world’s healthiest workforce you can strengthen your body as well and your mind. You can touch over a Billion lives worldwide every day. And when you apply your talent to our collective purpose there’s no end to the lasting impact we can make together. And that changes everything.

What’s in it for YOU ?

It’s important to us that you feel you can bring your whole self to work; at Johnson & Johnson we provide an environment for you to fulfil your career aspirations as well as promoting your physical and mental wellbeing. You will receive a competitive compensation and benefits package as well as benefits that can be tailored to what is valuable to you throughout different stages of your life. Examples of this include online Digital GP, private healthcare, Retail Vouchers, Discounted & Subsidised Gym memberships and you can get to support community projects as part of our global Corporate Social Responsibility programme.

For U.S. applicants, in accordance with applicable disclosure requirements, the anticipated base pay range for this position is $104,000 to $165,700.

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 may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, long-term incentive, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below.

For additional general information on company benefits, please go to:

• https://www.careers.jnj.com/employee-benefits

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 .]