Manager, Regulatory Medical Writing X-TA

OverviewpWe 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. The position may be located High Wycombe, UK; Leiden, Netherlands; Neuss, Germany; Paris, France; or Beerse, Belgium. The position is Hybrid (3 days onsite weekly). Remote work options may be considered on a case-by-case basis and if approved by the company. /pbrSolliciteer (door op de betreffende knop te klikken) na het doornemen van alle gerelateerde vacature-informatie hieronder.brpAre you ready to join our team? Then please read further! /pResponsibilitiesulliPreparing and finalizing all types of clinical documents. /liliLeading 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. /liliLeading or setting objectives for others on team projects and tasks, eg, leading process working groups. /liliGuiding or training cross-functional team members on processes and best practices. /liliPotentially leading project-level/submission/indication writing teams. /liliProactively providing 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. Responsible for planning and leading the writing group for assigned program. /liliActively participating in medical writing and cross-functional meetings. /liliMaintaining knowledge of industry, company, and regulatory guidelines. /liliCoaching 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. /liliInteracting with senior cross-functional colleagues to strengthen coordination between departments. /liliMay be representing Medical Writing department in industry standards working groups. /li /ulQualificationsulliUniversity/college degree required. Masters or PhD preferred. /liliAt least 8 years of relevant pharmaceutical/scientific experience; at least 6 years of relevant medical writing experience is required. /liliExperience of multiple therapeutic areas preferred. /liliAttention to detail. /liliExcellent oral and written communication skills are pivotal to engage in cross-functional discussions. English fluency required. /liliExpert project/time management skills. /liliStrong project/process leadership skills. /liliAbility to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content. /liliAble to resolve complex problems independently. /liliDemonstrate learning agility. /liliAble 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. xgiwjmb /li /ulWork ArrangementpHybrid Work – 3 days onsite weekly with remote work options considered on a case-by-case basis and if approved by the company. /pbr