Manager, Regulatory Medical Writing - Immunology 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. Learn more at https://www.jnj.com/. We are recruiting for a Manager, Regulatory Medical Writing, located in the UK, to support our Immunology therapeutic area. Alternative EU locations can be considered: Netherlands, Slovakia, Czech Republic, Italy, Poland, Portugal, Belgium, Germany, Spain, France, Hungary, Bulgaria, Ireland, Finland, Denmark, Sweden; also Switzerland and Norway; also India. Remote working options may be considered on a case-by-case basis and with the approval of the business. Are you ready to join our team? Then please read further Key Responsibilities : Prepare and finalize clinical documents such as, but not limited to, clinical study reports, investigator's brochures, study protocols, summary documents, risk management plans, regulatory responses, and briefing documents. Take a lead role with respect to content and scientific strategy. Lead cross-functional document planning and review meetings. Interact with peer writers and colleagues from other departments. Able to lead program-level or submission writing teams with general supervision. Able to lead process working groups. Coach or mentor more junior writers on document planning, processes, content, and provide peer review as needed. You may lead the work of other medical writers, external contractors, and document specialists supporting a project. Responsible for establishing document timelines and strategies in accordance with internal processes, with minimal guidance. If a lead writer for a program: Primary point of contact and champion for medical writing activities for the clinical team. Responsible for planning, setting strategy, and leading writing group for assigned program. Work with a high level of independence, taking responsibility on assigned projects for timing, scheduling, and tracking. Champion medical writing standard processes and provide recommendations for departmental process improvements. Maintain and disseminate knowledge of the industry, company, and regulatory guidelines. The role has potential to progress to being a people manager. If a people manager you will: Manage direct reports in Regulatory 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 decision on hiring staff, onboarding new staff, conducting career and talent development discussions for staff, lead in goal‐setting and performance discussions.