Senior Director Global Labeling

Janssen R&D is recruiting for a Senior Director, Global Labeling, located in any of the following locations: Chesterbrook, PA; Raritan, NJ; Titusville, NJ; Beerse, Belgium; Basel, Switzerland and High Wycombe, UK.

The Head, Global Labeling Centre of Excellence (GL CoE) drives labeling excellence for Janssen Pharmaceutical products. This role leads the department responsible for developing optimal labeling strategies, driving global labeling content (via the Company Core Data Sheet and US/EU labeling documents), maintaining global oversight of labeling submission compliance, and implementing labeling content into artwork for the US market.

As Chair of the Global Labeling Committee, this position has overall accountability for maintaining the framework which governs the development, review and approval of product labeling, ensuring that quality standards are consistently achieved. This position actively builds effective partnerships with multiple groups across R&D, Quality and Supply Chain, to ensure the required cross-functional engagement and strategic alignment to deliver optimal labeling.

As an inspirational leader in the labeling space, the Head, GL CoE expertly navigates the growing complexity of regulatory and drug development processes and embraces ambiguity and uncertainty. The role serves as an expert resource and a strategic partner to multiple senior team members, pushing boundaries and informing regulatory strategy. The position is actively engaged externally in shaping future regulations relevant to product labeling and its delivery to healthcare providers and patients, through trade associations (e.g., Labelnet, DIA). This role drives continuous innovation across the labeling process, exploiting opportunities to use emerging technology and encouraging a culture where novel and creative solutions to far-reaching problems can be embraced.

As the head of department for a team of around 50 people, this role celebrates a diverse set of backgrounds and champions an inclusive culture where people feel empowered to express themselves openly and are motivated to pursue opportunities aligned with their personal goals and aspirations.

Key Responsibilities:

• Provides strategic leadership and oversight to ensure the GL CoE consistently delivers high quality product labeling aligned with regulatory requirements, business priorities and compliance obligations

• Drives excellence in end-to-end labeling content development and implementation throughout a products lifecycle (i.e., from Target Labeling through Established Products) for all Janssen pharmaceutical products worldwide

• Integrates multiple inputs from regional and functional team members to create coherent and unified global labeling strategies.

• Chairs the Labeling Committee to ensure effective and efficient review and approval of labeling content (CCDS, US, EU)

• Maintains a high level of engagement externally with health authorities and through trade associations to ensure J&J is appropriately represented in policies and external initiatives that may shape regulations affecting product labeling.

• Contributes to the strategic direction, strategic objectives, and business plan for the LSM and GRA Leadership teams.

• Develops and implements mechanisms to monitor the organizational performance of the GL CoE that drives continuous improvement and innovation, and ensure processes and tools are in place to maintain compliance

• Drives day-to-day business results to include the coaching, training, and development of team members deployed at multiple sites and regions including US, UK, the Netherlands, Switzerland, Canada, and Belgium

• Provides leadership that promotes employment development, innovation, is customer focused, empowers and motivates others, fosters collaboration and delivers results.

Qualifications

Education:

• Minimum of Bachelors degree in a scientific discipline required

• Advanced degree (MS, PhD, MD) strongly preferred; clinical, drug safety or medical experience highly desirable.

  Experience and Skills:

Required:

• At least 10 years of relevant industry experience; Minimum of 8 years experience in Regulatory Affairs with experience in product labeling/labeling regulations highly desired.

  Preferred:

• Successful record of leadership in a global, diverse organization, and within a high pressure, time sensitive environment

• Demonstrates a high level of self-awareness and adaptability resilient, willing to learn from others, optimistic, flexible and adaptable

• Experience developing and maintaining strong relationships, working with executive management, and the ability to inspire trust with staff, peers, and leaders.

• Strong collaboration and influential management skills to partner effectively across other business units.

• Experience successfully performing organizational change

• Demonstrates ability to implement innovative solutions, take risks in order to drive innovation and build an environment that makes it safe for others to try new ideas and take appropriate risks

• Exceptional communication, negotiation and partnering skills

• Influential, transformative, people leader with proven track record of people development and inspiring a learning culture

• Strong digital savvy; curiosity for emerging technologies and a desire to drive experimentation and adoption of digital technologies

• Travel domestic & international expected 10-20%

At Johnson & Johnson, were on a mission to change the trajectory of health for humanity. That starts by creating the worlds healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.

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.

Primary Location

United States-New Jersey-Titusville-1125 Trenton Harbourton Road

Other Locations

North America-United States-New Jersey-Raritan, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, Europe/Middle East/Africa-Switzerland-Basel-City-Basel, North America-United States-Pennsylvania-Chesterbrook, Europe/Middle East/Africa-United Kingdom-England-High Wycombe

Organization

Janssen Research & Development, LLC (6084)

Job Function

Regulatory Affairs

Requisition ID