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Data publikacji: 01.11.2026
As Medical Operations Manager, EU West, you will report to the Medical Director EU West and partner closely with the Medical Advisor EU West to build the operating backbone for the affiliate's three rare-disease launches in achondroplasia, limb-girdle muscular dystrophy, and genetic hypocalcaemia. You will own the planning, logistics, systems, and financial coordination of Medical Affairs activities and coordinate local regulatory, compliance, and LEA workflows. The main focus of this role will be France. This is a France-based role with the Paris area as the designated office location, with regular travel across France and periodic travel to the International Headquarters in Zug, Switzerland, and to other countries in the Europe West region.
Responsibilities
Medical operations planning: Translate the France medical strategy into an integrated operational plan, activity calendar, RACI, budget, milestones, risks, and KPI dashboard across the three portfolio programs; Activity and event delivery: Manage end-to-end operations for advisory boards, scientific meetings, congresses, medical education, internal training, and field initiatives; Regulatory coordination: Serve as the affiliate operational contact for Regulatory Affairs, coordinating local inputs, translations, document readiness, correspondence, regulatory intelligence, product information, and launch-readiness actions; Compliance and LEA governance: Coordinate activities under the French Law on the Regulation of Benefits (LEA), including declaration or authorization workflows and auditable files in partnership with Legal and Compliance; French transparency requirements: Support accurate and timely capture, reconciliation, and submission of reportable agreements, remuneration, and benefits; Medical review operations: Administer the review and approval workflow for scientific, educational, and cross-functional materials; External funding and research operations: Coordinate medical grants, sponsorships, donations, investigator-sponsored research, and other external requests from intake through close-out; Data privacy and records: Embed privacy-by-design and appropriate consent, retention, access, and data-handling practices into medical activities; Budget and vendor management: Own Medical Affairs budget tracking and forecasting; manage vendor sourcing, contracts, purchase orders, invoices, and performance reviews; Systems and reporting: Maintain Medical Affairs systems and repositories, drive data quality and user adoption; SOPs training and audit readiness: Maintain local procedures, training matrices, and evidence of completion; support monitoring, audits, inspections, deviations, and CAPAs; Launch readiness and cross-functional delivery: Maintain the medical launch-readiness tracker and coordinate dependencies with cross-functional and regional or global colleagues; Safety and quality routing: Ensure operational pathways for escalation of adverse events, product complaints, and medical information requestsRequirements
PhD, PharmD, Bachelor's or Master's degree in life sciences, pharmacy, business, project management, or a related discipline; At least 2-5 years of Medical Affairs operations, commercial operations, regulatory operations, compliance operations, or comparable experience in the pharmaceutical or biotechnology industry; Hands-on experience delivering healthcare professional engagements, congresses, advisory boards, grants, sponsorships, or externally sponsored research in France; Working knowledge of French transparency, anti-benefit, data-protection, contracting, and record-retention requirements relevant to life-sciences activities; Experience coordinating regulatory or launch-readiness deliverables with regional or global teams and external partners; Strong budget, procurement, vendor, contract, timeline, and risk-management capabilities; Proficiency with Microsoft 365 and experience with CRM, content approval, or document-management systems; ability to learn new platforms quickly; Fluent French and professional English, both written and spokenNice to have
Experience in Medical Affairs operations for rare diseases or specialty medicines, including at least one pre-launch or launch; Experience in a small biotechnology affiliate, a new country organization, or another resource-constrained environment requiring hands-on execution; Practical experience with LEA workflows, transparency reporting, medical review systems, early access operations, or French regulatory coordination; Project-management or process-improvement certification; Operate independently and quickly, with a strong sense of ownership; Exceptional organization, attention to detail, and follow-through; A practical compliance mindset and the confidence to raise risks early; Ability to prioritize across products, stakeholders, and geographies; Calm, service-oriented collaboration under tight deadlines; Direct and clear communication in both French and EnglishJak aplikować
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