We are searching for the best talent for a Senior Manager/Associate Director, Regulatory Medical Writing within our Integrated Data Analytics & Reporting (IDAR) business. This role will support our Immunology Regulatory Medical Writing area. The position can be located at any of our following offices: High Wycombe (UK), Beerse (Belgium), Leiden (Netherlands), Allschwil (Switzerland), or Spring House/Raritan/Titusville (East Coast US). Hybrid (3 days per week onsite) is strongly preferred. Remote work options may be considered on a case-by-case basis and if approved by the company.You will be responsible for:Leading compound/submission/indication/disease area writing teams independently.Directly leading or setting objectives for others on team projects and tasks, eg, able to lead Medical Writing (MW) process working groups or Communities of Practice.Writing or coordinating all types of clinical and regulatory documents, taking a proactive or lead role in terms of content and scientific strategy.Establishing and driving document timelines and strategies independently.Guiding or training cross-functional team members on processes and best practices.Proactively identifying and championing departmental process improvements.May lead cross-functional, cross-therapy area, or cross-J&J process improvement initiatives.Leading discussions in MW and cross-functional meetings as appropriate (eg, submission team meetings, Global Program Team meetings, study team meetings, clinical team meetings).Maintaining and disseminating knowledge of industry, company, and regulatory guidelines.Interacting with senior cross-functional colleagues and external partners to strengthen coordination between departments.As a people manager:Supervising/managing and being accountable for direct reports.Setting objectives and agreeing on goals for direct reports. Providing performance oversight, including feedback on performance and development.Regularly meeting with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.Coaching or mentoring more junior writers on document planning, processes, content, and provides peer review as needed.Ensuring direct report's adherence to established policies, procedural documents, and templates.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.Requirements:A university/college degree in a scientific discipline is required. An advanced degree (eg, Masters, PhD, MD) is preferred.At least 10 years of relevant pharmaceutical/scientific experience.At least 8 years of relevant clinical/regulatory medical writing experience.At least 2 years of direct people management experience.Experience in project management and process improvement.Advanced knowledge and application of regulatory guidance such as ICH requirementsRecognizes how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types independently.Resolves complex problems independently.Proactively identifies potential risks and develops strategies to mitigate.Ability to serve as the liaison between team members and senior leadership within a therapy area.Ability to build and maintain solid and positive relationships with cross-functional team members.Excellent oral and written communication skills.Attention to detail.Expert time management for self and team.Expert project management skills, expert project/process leadership.Strong leadership skills (influencing, negotiating, assertiveness, taking initiative, conflict management, change management).Ability to delegate responsibility to junior writers.Ability to lead by example, stay focused and positive, and act with integrity.Ability to internalize and teach CREDO behaviours.Ability to act as change agent and adapt to rapidly changing organizational & business challenges.Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. #J-18808-Ljbffr