Senior Director, Regulatory Medical Writing

Company: Disability Solutions
Location: Spring House
Posted on: February 5, 2025

Job Description:

Johnson & Johnson Innovative Medicine is recruiting for a Senior Director, Regulatory Medical Writing to be located in Springhouse, Pennsylvania, Allschwil, Switzerland, Beerse, Antwerp, Belgium, High Wycombe, Buckinghamshire, United Kingdom, Raritan or Titusville, New Jersey United States of America.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 across the Oncology therapeutic area.This role as Head of Oncology Regulatory Medical writing 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:

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• 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.\rAdvising/Influencing:
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  • 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.\r Collaborating:
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    • 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.\rInnovating:
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      • 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.\rPrincipal 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.\r

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