Director, Global Labeling Head, Immunology
Janssen Research & Development, a member of Johnson & Johnson's Family of Companies, is recruiting for a Director, Therapeutic Area Head. The position will be based at any of the following Janssen R&D sites: US (Titusville, NJ, Raritan, NJ or Spring House, PA), or UK (High Wycombe).
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.
Janssen Pharmaceuticals, Inc. provides medicines for an array of health concerns in several therapeutic areas, including Cardiovascular, Metabolic, Mental Health, and Pain Management. Please visit www.JanssenPharmaceuticalsInc.com for more information.
The Director, Therapeutic Area Head will:
• Be assigned to a therapeutic area, product(s) or portfolio with oversight and accountability for creation of the global labeling strategy (with the Global Regulatory Team and the Labeling Working Group) in line with the global regulatory strategy, primary and derived labeling documents and text for artwork for packaging components and target labeling
• Work with customers and stakeholders to ensure the labeling deliverables meet compliance and quality standards, liaising with third party companies on labeling-related issues.
• Partner with the Global Regulatory Affairs Therapeutic Area (TA) Head regarding strategy, prioritization and resourcing.
• Accountable for the development and growth of direct reports.
• Make decisions that impact the functional area regarding overall staffing strategy and assignments.
• Will have a significant impact on the strategic direction and effectiveness of the overall labeling organization. Lead decisions that impact departmental guidelines, standards, processes, and resourcing.
• Accountable for recommendations and decisions that have both a short-term (up to 1-year) and long-term (1 to 5 years or greater) focus with respect to the needs of the department and direct reports.
• Provides guidance to cross-functional teams and leadership regarding appropriateness of content and scientific integrity, as well as processes and timelines.
• Oversight and accountability for developing and executing the global labeling strategy for all compounds in the TA and leads the development of processes relating to labeling content, maintenance and implementation.
• Takes a leadership role and partners with Global Regulatory Leaders to ensure the global labeling strategy aligns with the global regulatory strategy for assigned products/TA.
• Provides strategic direction and oversight to other labeling roles to ensure high quality primary and derived labeling documents and labeling submission planning activities are delivered in support of the global labeling strategy.
• Advises on interactions with third party companies on product or TA-specific labeling-related issues, as required.
• Takes a leadership role with labeling customers and stakeholders to continuously assess the labeling process for improvement and efficiencies and to meet labeling compliance and quality standards.
• Supports the GL CoE during audits and inspections and the management of labeling CAPAs as required. Ensures that knowledge gained from audits, inspections and CAPAs is incorporated into the standard work of the GL CoE for continuous process improvement.
• Ensures appropriate GL CoE representation and influence on industry and trade organizations including those relating to labeling content, processes, compliance and standards.
• Provides leadership and fosters individual development and motivation. Assesses and prioritizes current and incoming workload of direct reports.
• A minimum of a Bachelor’s degree is required. An advanced degree (MD, PhD, MS, MBA, PharmD, etc.) is preferred.
• A minimum of 10 years of pharmaceutical industry or health authority experience is required.
• A minimum of 8 years of Regulatory Affairs with experience in product labeling/labeling regulations, or equivalent is required.
• Working knowledge of worldwide health authority laws, regulations, guidance for labeling is required.
• Understanding of competitors’ labeling in the therapeutic area and knowledge of labeling aspects is preferred.
• An understanding of drug development is required.
• Understanding of life sciences relevant to therapeutic area is required.
• Experience leading teams within a matrix environment with an emphasis on collaborative, customer focused, and learning culture is required.
• People management experience is required.
• Strong verbal and written communication, negotiation, conflict resolution, and partnering skills are required.
• Strong Microsoft Word skills and experience working in document management systems are required. Basic Excel and PowerPoint skills are required.
• Experience leading continuous improvement projects is required.
• This position is located at any of the following Janssen R&D sites: US (Titusville, NJ, Raritan, NJ or Spring House, PA), or UK (High Wycombe), and may require up to 10-20% travel.
BE VITAL in your Career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W: LI NA
J2W: LI EMEA
United States-New Jersey-Raritan
Europe/Middle East/Africa-United Kingdom-England-High Wycombe, North America-United States-Pennsylvania-Spring House, North America-United States-New Jersey-Titusville
Janssen Research & Development, LLC. (6084)