Manager, Regulatory Medical Writing X-TA

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. Medical Affairs Group Medical Writing Beerse, Antwerp, Belgium, Issy-les-Moulineaux, France, Leiden, South Holland, Netherlands, Neuss, North Rhine-Westphalia, Germany Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Learn more at We are searching for the best talent for a Manager, Regulatory Medical Writing to support across key therapeutic areas (X-TA) within our Integrated Data Analytics & Reporting (IDAR) business. Leiden, Netherlands; 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? Preparing and finalizing all types of clinical documents. Leading in a team environment. Working with a high level of independence and taking a lead role on assigned projects with respect to content and scientific strategy, timing, scheduling, and tracking. Leading or setting objectives for others on team projects and tasks, eg, leading process working groups. Guiding or training cross-functional team members on processes and best practices. Potentially leading project-level/submission/indication writing teams. 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. Actively participating in medical writing and cross-functional meetings. Coaching or mentoring more junior staff on document planning, processes, content, and provide peer review as needed; overseeing the work of other medical writers, external contractors, and document specialists supporting a project. Interacting with senior cross-functional colleagues to strengthen coordination between departments. May be representing Medical Writing department in industry standards working groups. University/college degree required. Masters or PhD preferred. At least 8 years of relevant pharmaceutical/scientific experience; at least 6 years of relevant medical writing experience is required! English fluency required. Expert project/time management skills. Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content. 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. Netherlands, Germany, France, Belgium- Requisition Number: Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform important job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodations. Clinical Study Reports, Medical Writing, Project Management Leadership, Regulatory Documents Business Writing, Clinical Research and Regulations, Clinical Trials Operations, Coaching, Collaborating, Copy Editing, Data Synthesis, Industry Analysis, Medical Affairs, Medical Communications, Process Improvements, Proofreading, Quality Validation, Standard Operating Procedure (SOP), Tactical Planning, Technical Credibility