Director, Medical Writing, Oncology

Director, Medical Writing, Oncology

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 Director, Medical Writing, Oncology. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s) :

United States - Requisition Number : R-038874

Belgium & Netherlands- Requisition Number : R-039974

United Kingdom- Requisition Number : R-039973

Switzerland- Requisition Number : R-039972

Canada- Requisition Number : R-039966

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

The Director of Regulatory Medical Writing (RegMW) 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. The Director, RegMW has the authority to oversee projects, identify risks, and implement process improvements, while managing internal teams and contributing to organizational initiatives. Additionally, the role requires the ability to guide lead medical writers on one or several compounds with the same or different indications, leading within a team matrix environment, setting functional tactics, making strategic contributions, and proactively planning for resources.

You will be responsible for :

• Assume overall accountability for decision-making within the organization or TA, ensuring alignment with strategic goals.
• Proactively identify potential risks and develop strategies to mitigate them, enhancing project outcomes and minimizing obstacles.
• Recognize and resolve complex problems related to the development and implementation of new service offerings and deliverables, working independently to find effective solutions.
• Write or provide 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.
• Represent 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 lead or set objectives for team projects and tasks, including leading program-level, submission, indication, and disease area writing teams independently.
• Serve as a liaison between team members and senior leadership within a TA or sub-function, facilitating effective communication and collaboration.
• Develop, implement, and drive the institutionalization of departmental process improvements and best practices in collaboration with relevant Communities of Practice and Business Process Owners, championing these initiatives to cross-functional team members.
• Mentor, support, and coach staff at all levels on document planning, processes, and content, providing peer review as needed.
• Maintain and disseminate knowledge of industry, company, and regulatory guidelines within relevant company systems.
• Participate 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, in close consultation and accordance with the Delivery Unit (DU) in line with R&D priorities and TA objectives.
• Can represent MW DU Head or department at high-level and cross-functional TA meetings and has significant independent decision-making authority.
• Can step in for DU Head in case of absence.
• Is a major contributor to multiple deliverables for the function, TA, or DU.
• Provides leadership to their writing teams by helping attract and retain top talent, developing team members, and ensuring 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.
• Takes on additional major responsibility with minimal supervision, operating at an expert level with accountability for the highest levels of quality : cross-functional, cross-TA, cross-J&J initiative / collaboration. Larger organizational responsibility (eg, manage a subset of functional area / TA organization) with some level of independence to operate within that subset of the organization.
• Supervises / manages and is accountable for direct reports.
• Sets objectives and agrees on goals for direct reports. Provides performance oversight, including providing feedback on performance and development.
• Regularly meets with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.
• Ensures direct report's adherence to established policies, procedural documents, and templates.
• Participates in hiring staff, onboarding new staff, conducting career and talent development discussions for staff, goal-setting, end-of-year performance reviews, and compensation planning.
• If applicable, frequent engagement with staff and leading discussions on employee development and talent management.

Qualifications / Requirements :

Other :

The expected pay range for this position is $160,000 to $276,000.

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.