Senior Director, Medical Writing

Johnson & Johnson; Titusville (FL); On-site; USD 120,000 - 180,000; Full time

Job summary

Join a forward-thinking company as a Senior Director in Regulatory Medical Writing. This influential role involves strategic leadership and collaboration across the organization to enhance medical writing capabilities. You'll drive innovation, oversee resource planning, and ensure high-quality deliverables while fostering an engaged and empowered environment. With a focus on continuous development and a commitment to excellence, this position offers a unique opportunity to impact the future of healthcare solutions. If you have a passion for leadership and a background in clinical development, this role is perfect for you.

Qualifications

• Minimum 15 years in clinical development with expert knowledge of medical writing.
• Over 5 years in senior leadership roles in a global matrix environment.

Responsibilities

• Lead the Reg MW Leadership Team and establish strategy for medical writing effectiveness.
• Oversee resource planning and ensure organizational effectiveness.

Skills

Medical Writing

Leadership

Clinical Development

Regulatory Standards

Talent Development

Education

University/College Degree in Scientific Discipline

Advanced Degree Preferred

Job description

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

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 organizational development and leadership, ensuring efficient production and quality of all Reg MW deliverables. The role has independent decision-making authority impacting the direction and effectiveness of the Reg MW organization.

This position reports to the Head of Reg MW and is expected to represent Reg MW in a leadership capacity. It involves strong collaboration with senior functional and matrix leaders across the IMRD organization to ensure successful, high-quality, and compliant portfolio delivery.

Principal Responsibilities:

Leadership:

• Member of the Reg MW Leadership Team, reporting to the Global Head of department. Help establish the strategy and maximize medical writing effectiveness and productivity.
• Responsibility for functional leadership with high impact in a competitive landscape. Navigate complex organizational structures and serve as Reg MW interface for respective Therapeutic area and Delivery Unit.
• Drive capability development and organizational structure shaping across a large portfolio.

Advising/Influencing:

• Oversee resource planning, prioritization, and allocation to support programs and projects within the therapeutic area.
• Provide leadership to employees, including Director level roles, managing development, recruitment, and training to meet business needs.
• Ensure organizational effectiveness, transparency, and communication, fostering an engaged and empowered environment.

Collaborating:

• Work with the Global Head of Reg MW to clarify strategy and processes, ensuring effective communication and engagement.
• Drive cross-functional senior leadership engagement and develop solutions for new service capabilities.
• Represent J&J externally in medical writing and related capacities, establishing Reg MW as an industry leader.

Innovating:

• Lead continuous development and application of innovative operating models.
• Lead, inspire, and influence large teams through business challenges.
• Lead initiatives to improve department processes and drive change across functions.

Principal Relationships:

This position reports to the Global Head of Reg MW. Internal engagement includes senior heads and matrix leaders across Therapeutic and Functional Areas, while external relationships involve vendor partners, authorities, and industry peers.

Education and Experience Requirements:

• A university/college degree in a scientific discipline; advanced degrees preferred.
• Minimum 15 years in clinical development, with expert knowledge of medical writing.
• Over 5 years in senior leadership roles, with experience in a global matrix environment.
• Extensive leadership experience in talent development and performance management.
• Strong understanding of clinical development, quality, and regulatory standards (e.g., GCP, ICH).