.Associate Director, Oncology Regulatory Medical Writing at Johnson & Johnson Innovative Medicine. What matters most is helping people live full and healthy lives.We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time.Johnson & Johnson Innovative Medicine discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiopulmonary, and retina.Within Integrated Data Analytics & Reporting (IDAR), the Regulatory Medical Writing team is recruiting for an Associate Director to support our Oncology therapeutic area.The position may be located in the UK, other European countries, or Canada. Remote work options may be considered on a case-by-case basis and if approved by the company.Are you ready to join our team? Then please read further!Key ResponsibilitiesPrepare and finalize all types of clinical documents, taking a proactive or lead role in terms of content and scientific strategy.Work with a high level of independence and take a lead role with respect to timing, scheduling, and tracking.Able to lead program-level/submission writing teams independently.Directly lead or set objectives for others on team projects and tasks.Guide or train cross-functional team members on processes, best practices; coach or mentor more junior writers.Proactively identify and champion Medical Writing process improvements.Able to develop and present best practices to external audiences.Able to lead cross-functional/cross-TA, cross-J&J process improvement initiatives, or other process working group.If a lead writer for a program, serve as the primary point of contact and champion for medical writing activities for the clinical team.Responsible for planning and leading the writing group for assigned program.Lead discussions in Medical Writing and cross-functional meetings as appropriate.Maintain and disseminate knowledge of industry, company, and regulatory guidelines.Interact with senior cross-functional colleagues and external partners to strengthen coordination between departments.Able to represent Medical Writing in industry standards working groups.If a people manager, manage direct reports in Medical Writing.Set objectives for individual team members.Regularly meet with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.Able to make decisions on hiring staff, onboarding new staff, conducting career and talent development discussions for staff, lead in goal setting and performance discussions.QualificationsEducation: University/college degree required; Masters or PhD preferred.Experience and Skills: At least 12 years of relevant pharmaceutical/scientific experience; at least 10 years of relevant medical writing experience is required. If a people manager, at least 2 years of people management experience.Oncology therapeutic area experience preferred
