Director, Medical Writing, Oncology in High Wycombe

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.

We are searching for the best talent for the Director of Regulatory Medical Writing (RegMW) role. This position is recognized as a leader with extensive medical writing expertise for documents across various therapeutic areas (TAs). This role is a primary liaison with cross-functional teams, driving strategic discussions, developing internal medical writers, and ensuring adherence to best practices and regulatory guidelines.

You will be responsible for:

• Assuming overall accountability for decision-making within the organization or TA, ensuring alignment with strategic goals.
• Proactively identifying potential risks and developing strategies to mitigate them, enhancing project outcomes and minimizing obstacles.
• Recognizing and resolving complex problems related to the development and implementation of new service offerings and deliverables, working independently to find effective solutions.
• Writing or providing guidance to other writers on all types of clinical, regulatory, and safety documents, taking a proactive lead in content and scientific strategy with complete independence.
• Representing the MW department with decision-making authority in the R&D organization, leading discussions with senior cross-functional colleagues and external partners to enhance coordination between departments.
• Directly leading or setting objectives for team projects and tasks, including leading program-level, submission, indication, and disease area writing teams independently.
• Serving as a liaison between team members and senior leadership within a TA or sub-function, facilitating effective communication and collaboration.
• Developing, implementing, and driving the institutionalization of departmental process improvements and best practices in collaboration with relevant Communities of Practice and Business Process Owners.
• Mentoring, supporting, and coaching staff at all levels on document planning, processes, and content, providing peer review as needed.
• Maintaining and disseminating knowledge of industry, company, and regulatory guidelines within relevant company systems.
• Participating in industry standards working groups to represent MW and ensure alignment with best practices.
• Accountable for setting the strategy and operational execution for their portfolio(s) within the Medical Writing (MW) team.
• Providing leadership to their writing teams by helping attract and retain top talent, developing team members, and ensuring organizational effectiveness, transparency, and communication.
• Creating an environment where employees feel engaged and empowered, and take pride in their role, responsibilities, and deliverables.
• Supervising/managing and being accountable for direct reports, including setting objectives and agreeing on goals.
• Participating in hiring staff, onboarding new staff, conducting career and talent development discussions for staff, goal-setting, end-of-year performance reviews, and compensation planning.

Qualifications / Requirements:

• A university/college degree in a scientific discipline is required.
• An advanced degree (e.g., Masters, PhD, MD) is preferred.
• Minimum of 14 years of relevant pharmaceutical/scientific experience is required.
• Minimum of 12 years of relevant clinical/medical writing experience is required.
• Minimum of 5 years of people management experience is required.
• Expertise in project management and process improvement is required.
• Strong decision-making skills, strategic thinking, agility, and broad vision are required.

Other:

• Excellent oral and written communication skills.
• Attention to detail.
• Expert time management for self, direct reports (if applicable), and teams.
• Ability to delegate responsibility to other medical writers.
• Expert ability to lead and influence by example and stay focused (positive).
• Demonstrate integrity.
• Expert ability to motivate and develop best in class talent pipeline.
• Demonstrated ability to collaborate internally and develop effective partnerships with key business partners and customers.
• Creates a positive Credo-based work environment for staff members.
• Shows openness to new ideas and fosters organizational learning.