Johnson & Johnson Innovative Medicine is recruiting for a Senior Director,Global Regulatory Affairs Leader to be located in Pennsylvania, New Jersey, Beerse, Belgium, High Wycombe, UK , Zug, Switzerland or Singapore. This position reports to the Global Head of Regulatory Medical Writing.
At Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com.
The Senior Director, Regulatory Medical Writing (Reg MW) is a highly experienced and influential leader with expert knowledge of Reg MW strategic concepts and processes. This position is accountable for the strategic and operational leadership of Reg MW activities across one or more Therapeutic Areas, with organizational scope typically 20% of Reg MW demand (or 40 FTEs or equivalent budget) across geographic regions.This role requires a well-established leader, with a recognized track record of substantial organizational development and leadership, assuring efficient production and quality of all Reg MW deliverables. This role has independent decision-making authority for decisions that could have significant/long-term impact on the direction and effectiveness of the Reg MW organization.
The Senior Director Reg MW is accountable for the management, development, recruitment and training of employees within the departmental scope, including Director level roles, to meet current and future business needs.
This position reports to the Head of Reg MW and is expected to be capable of representing Reg MW and IDAR in a leadership capacity. The role requires strong partnership and close collaboration with senior functional and matrix leaders across the Innovative Medicine R&D (IMRD) organization to ensure the successful, efficient, high-quality and compliant delivery for a significant portfolio area.
Principal Responsibilities:

Member of the Reg MW Senior Leadership Team with accountability for large and/or complex strategically impactful Therapeutic Area(s) portfolio within Reg MW (typically leadership span 20% of overall Reg MW demand or 40 FTEs or equivalent budget across geographic regions).

• Responsibility for functional TA(s) leadership with high material impact for company in a strong competitive landscape. Needs to navigate challenging and complex organizational structure in TA(s). Point of contact for the Global Development (GD) Delivery Unit Leadership Team and acts as Reg MW interface for respective GD Delivery Unit.
• Strategic leadership accountabilities include driving the development of capabilities and shaping organizational structures across a large and/or complex functional portfolio and/or the role’s geographical scope.
• Provides exceptional leadership to employees within responsible areas. Leads coaching and development of employees, including Director level individuals across the function.
• Able to represent department in cross-functional discussions and step-in for Head of Reg MW as needed, including on Reg MW SLT. Lead discussions with senior R&D colleagues to strengthen coordination between cross-functional and cross-sector departments. This position has direct interface with senior stakeholders and influencers across IMRD including TA and Functional Leaders in GD Delivery Units, Clinical, GRA, GMS, BRQC, Planning and Finance.
• Aligns with Business, Functional, and TA Heads/teams on key portfolio objectives and priorities to develop and influence the strategy and direction of Reg MW. Interacts with IDAR and GD colleagues, therapeutic or functional area leaders to execute on the organizational priorities, with a focus on quality RegMW deliverables.
• Excellent organizational ability to manage MW workload (incl across TAs) and ensure appropriate resource allocation is in place for optimal portfolio support. High level of vendor engagement/utilization with potential to impact and drive vendor capacity due to span or complexity of portfolio demand.
• Decision-making has significant/long-term impact on the direction and effectiveness of the functional and/or regional organization due to the large scope, strategic and business impact, and/or span of area of responsibility. Build medical writing teams in new locations/areas as needed to augment Reg MW development.
• Leader in continuous development and adjustment of innovative operating models. Able to lead, inspire and influence large team/organization through rapidly changing business challenges.
• Provide a leadership role in department process development and optimization of related clinical research activities. Sponsors/leads initiatives with impact to drive change within and across functions and sectors.
• Drives cross-functional senior leadership engagement to develop and deliver solutions for new service capabilities.
• Works with Head Reg MW to ensure the department strategy and processes are clear towards all stakeholders with optimal communication and engagement. Align processes and priorities to maximize organizational effectiveness; designs and implements innovative approaches to enhance productivity and effectiveness.
• Externally leading and sought-after for insights and functional expertise from across industry; able to represent J&J in medical writing and other related capacities. Helps establish Reg MW as an industry leader.
• Contributes to development and analysis of performance metrics and identifies ways to raise department standards. Responsible for team adherence to standards and compliance.
• Provides leadership by attracting and retaining top talent, developing team members, and ensuring organizational effectiveness, transparency, and communication. The position is responsible to create an environment where employees feel engaged and empowered, and take pride in their roles, responsibilities, and deliverables.
• Strong customer focus and belief in Credo values; creates a positive Credo-based work environment for Reg MW department.

Internal relationships:
Regular and direct engagement with Senior Heads and Matrix Leaders from Therapeutic and Functional Areas including: Clinical (Therapeutic Area Heads), GD Delivery Units, Integrated Data Analytics and Reporting, Statistics and Decision Sciences, Data Sciences, Bio Research Quality & Compliance, Project Management Organization, Global Clinical Operations, Medical Affairs Operations, Global Medical Safety, Global Regulatory Affairs and Operations, Human Resources, Talent Acquisition, Finance, IT, Procurement, External Alliances and Cross-sector counterparts.
External relationships:
Vendor Partners, Consultants, Health Authorities, Professional Societies, Industry Peers and Leaders.

QUALIFICATIONS

Education and Experience Requirements:

• A university/college degree in a scientific discipline is required. An advanced degree (e.g., Masters, MBA, MD, PhD) is preferred.
• A minimum of 15 years’ experience in clinical development required with expert knowledge of medical writing.
• 5+ years in a senior functional leadership role is required. Demonstrated track record of working within a global matrix environment.
• Extensive people leadership experience including talent development and performance management.
• Excellent understanding of clinical development, quality and regulatory standards and policies relevant to medical writing (e.g., GCP, ICH)

The anticipated range for this opportunity is in US Dollars: $193,000- $333,500
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.
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

• Responsibility for functional TA(s) leadership with high material impact for company in a strong competitive landscape. Needs to navigate challenging and complex organizational structure in TA(s). Point of contact for the Global Development (GD) Delivery Unit Leadership Team and acts as Reg MW interface for respective GD Delivery Unit.
• Strategic leadership accountabilities include driving the development of capabilities and shaping organizational structures across a large and/or complex functional portfolio and/or the role’s geographical scope.
• Provides exceptional leadership to employees within responsible areas. Leads coaching and development of employees, including Director level individuals across the function.
• Able to represent department in cross-functional discussions and step-in for Head of Reg MW as needed, including on Reg MW SLT. Lead discussions with senior R&D colleagues to strengthen coordination between cross-functional and cross-sector departments. This position has direct interface with senior stakeholders and influencers across IMRD including TA and Functional Leaders in GD Delivery Units, Clinical, GRA, GMS, BRQC, Planning and Finance.
• Aligns with Business, Functional, and TA Heads/teams on key portfolio objectives and priorities to develop and influence the strategy and direction of Reg MW. Interacts with IDAR and GD colleagues, therapeutic or functional area leaders to execute on the organizational priorities, with a focus on quality RegMW deliverables.
• Excellent organizational ability to manage MW workload (incl across TAs) and ensure appropriate resource allocation is in place for optimal portfolio support. High level of vendor engagement/utilization with potential to impact and drive vendor capacity due to span or complexity of portfolio demand.
• Decision-making has significant/long-term impact on the direction and effectiveness of the functional and/or regional organization due to the large scope, strategic and business impact, and/or span of area of responsibility. Build medical writing teams in new locations/areas as needed to augment Reg MW development.
• Leader in continuous development and adjustment of innovative operating models. Able to lead, inspire and influence large team/organization through rapidly changing business challenges.
• Provide a leadership role in department process development and optimization of related clinical research activities. Sponsors/leads initiatives with impact to drive change within and across functions and sectors.
• Drives cross-functional senior leadership engagement to develop and deliver solutions for new service capabilities.
• Works with Head Reg MW to ensure the department strategy and processes are clear towards all stakeholders with optimal communication and engagement. Align processes and priorities to maximize organizational effectiveness; designs and implements innovative approaches to enhance productivity and effectiveness.
• Externally leading and sought-after for insights and functional expertise from across industry; able to represent J&J in medical writing and other related capacities. Helps establish Reg MW as an industry leader.
• Contributes to development and analysis of performance metrics and identifies ways to raise department standards. Responsible for team adherence to standards and compliance.
• Provides leadership by attracting and retaining top talent, developing team members, and ensuring organizational effectiveness, transparency, and communication. The position is responsible to create an environment where employees feel engaged and empowered, and take pride in their roles, responsibilities, and deliverables.
• Strong customer focus and belief in Credo values; creates a positive Credo-based work environment for Reg MW department