Manager, Medical Writing, Immunology

pAt Johnson Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 jnj.com. As guided by Our Credo, Johnson Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson Johnson, we respect the diversity and dignity of our employees and recognize their merit. /ph3Job Function: Medical Affairs Group /h3h3Job Sub Function: Medical Writing /h3h3Job Category: People Leader /h3h3All Job Posting Locations: Allschwil, Basel-Country, Switzerland /h3h3Job Description /h3h3About Innovative Medicine /h3pOur expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at /ph3About Immunology /h3pOur Immunology team leads in the development of transformational medicines for immunological disorders and illnesses. You can influence where medicine is going by restoring health to millions of people living with immune diseases. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at /ph3Purpose /h3pWithin Integrated Data Analytics Reporting (IDAR), the Regulatory Medical Writing team is recruiting for a Manager, Regulatory Medical, Immunology. This position will support our Immunology therapeutic area. Are you ready to join our team? Then please read further! /ph3You will be responsible for /h3ulliPrepare and finalize all types of clinical documents. /liliLead in a team environment. /liliWork with a high level of independence and take a lead role on assigned projects with respect to content and scientific strategy, timing, scheduling, and tracking. /liliLead or set objectives for others on team projects and tasks, eg, lead process working groups. /liliGuide or train cross-functional team members on processes and best practices. /liliMay lead project-level/submission/indication writing teams. /liliProactively provide recommendations for departmental process improvements. /liliIf a lead writer for a program: Primary point of contact and champion for medical writing activities for the clinical team. /liliResponsible for planning and leading the writing group for assigned program. /liliActively participate in medical writing and cross-functional meetings. /liliMaintain knowledge of industry, company, and regulatory guidelines. /liliCoach or mentor more junior staff on document planning, processes, content, and provide peer review as needed; may oversee the work of other medical writers, external contractors, and document specialists supporting a project. /liliMay interact with senior cross-functional colleagues to strengthen coordination between departments. /liliMay represent Medical Writing department in industry standards working groups. /liliManage direct reports in Medical Writing. /liliSet objectives for individual team members. /liliRegularly meet with direct reports to ensure appropriate development, projects, assignments, and issues are resolved. /liliMake decision on hiring staff, onboarding new staff, conducting career and talent development discussions for staff, lead in goal‑setting, and performance discussions. /li /ulh3Qualifications/Requirements /h3ulliEducation: Minimum of University/college degree required. Masters or PhD preferred. /liliExperience and Skills: At least 8 years of relevant pharmaceutical/scientific experience; at least 6 years of relevant medical writing experience is required. 2 years of people management experience is preferred. Attention to detail. Excellent oral and written communication skills are pivotal to engage in cross-functional discussions. Expert project/time management skills. Strong project/process leadership skills. Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content. Able to resolve complex problems independently. Demonstrate learning agility. Able to build and maintain solid and positive relationships with cross‑functional team members. Solid knowledge and application of regulatory guidance documents such as ICH requirements. /li /ulh3Required Skills /h3pPreferred Skills: Analytics Insights, Business Writing, Clinical Research and Regulations, Clinical Trials Operations, Copy Editing, Cross-Functional Collaboration, Developing Others, Inclusive Leadership, Industry Analysis, Leadership, Medical Affairs, Medical Communications, Performance Measurement, Quality Validation, Standard Operating Procedure (SOP), Tactical Planning, Team Management /ppAt Johnson Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 /p #J-18808-Ljbffr