Johnson and Johnson

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 https://www.jnj.com

Job Function:

Medical Affairs Group

Job Sub Function:

Medical Writing

Job Category:

People Leader

All Job Posting Locations:

Titusville, New Jersey, United States of America

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

The primary work location for this role is Titusville, NJ. Remote work options may be considered on a case-by-case basis and if approved by the Company.

Position Summary:

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 role is accountable for the strategic and operational leadership of Reg MW activities.

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.

This position reports to the Head of Reg MW and is expected to be capable of representing Reg MW 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 portfolio delivery.

Principal Responsibilities:

Leadership:

• Member of the Reg MW Leadership Team, reporting into the Global Head of department. Help establish the strategy and direction of Reg MW and maximize medical writing effectiveness and productivity.
• Responsibility for functional leadership with high material impact in strong competitive landscape. Able to navigate complex organizational structure and act as Reg MW interface for respective Therapeutic area and Delivery Unit.
• Strategic leadership accountabilities include driving the development of capabilities and shaping organizational structures across a large and complex portfolio.

Advising/Influencing:

• Oversee resource planning, prioritization, and allocation to ensure programs and projects within the therapeutic area are optimally supported.
• Provides exceptional leadership to employees within responsible area. 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.
• Ensure organizational effectiveness, transparency, and communication. Responsible for creating an environment where employees feel engaged and empowered, and take pride in their role, responsibilities, and deliverables.

Collaborating:

• Works with Global Head of 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.
• Drives cross-functional senior leadership engagement to develop and deliver solutions for new service capabilities.
• 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. Help establish Reg MW as an industry leader.

Innovating:

• Leader in continuous development and application of innovative operating models.
• Able to lead, inspire and influence large team/organization through rapidly changing business challenges.
• Provide leadership 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.

Principal Relationships:

This position reports to the Global Head of Reg MW.

Internal relationships: Regular and direct engagement with Senior Heads and Matrix Leaders from Therapeutic and Functional Areas including: Clinical (Therapeutic Area Heads), Global Development Delivery Units, Integrated Data Analytics and Reporting, Statistics and Decision Sciences, Data Sciences, R&D Quality, Program Management Organization, Global Clinical Operations, Medical Affairs Operations, Global Medical Safety, Global Regulatory Affairs and Operations, Human Resources, Talent Acquisition, IT, Procurement, External Alliances and Cross-sector counterparts.

External relationships: Vendor Partners, Consultants, Health Authorities, Professional Societies, Industry Peers and Leaders.

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)