Chargement en cours

Manager, Medical Operations, EU West

FRANCE
il y a 4 jours

Mavericks Wanted

When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on

What You'll Do

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 (loi d'encadrement des avantages) workflows so that execution is efficient, documented, auditable, and aligned with BridgeBio standards and French requirements. The main focus of this role will be France.

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, including invitations, contracting, fair-market-value checks, travel, venues, purchase orders, invoices, and close-out documentation

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 with regional or global teams and external partners. Support early or compassionate access workstreams when applicable

Compliance and LEA governance: Coordinate activities under the French Law on the Regulation of Benefits (Loi d'Encadrement des Avantages, LEA), including the applicable declaration or authorization workflows for healthcare professional, healthcare organization, patient, and patient-organization engagements; maintain approval evidence, due-diligence records, contracts, 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 in line with French transparency and anti-benefit requirements and applicable industry standards

Medical review operations: Administer the review and approval workflow for scientific, educational, and cross-functional materials, including intake, routing, version control, source documentation, expiry management, and compliant archiving

External funding and research operations: Coordinate medical grants, sponsorships, donations, investigator-sponsored research, collaborative projects, and other external requests from intake through review, contracting, payment, milestone tracking, and close-out

Data privacy and records: Embed privacy-by-design and appropriate consent, retention, access, and data-handling practices into medical activities, particularly for health data, research, surveys, and stakeholder databases, in collaboration with the Data Protection Officer and relevant experts

Budget and vendor management: Own Medical Affairs budget tracking and forecasting; manage vendor sourcing, onboarding, contracts, purchase orders, invoices, service levels, and performance reviews in coordination with Finance and Procurement

Systems and reporting: Maintain fit-for-purpose Medical Affairs systems and repositories, including CRM and insight workflows, approval platforms, activity trackers, congress calendars, contact records, dashboards, and document libraries; drive data quality and user adoption

SOPs training and audit readiness: Maintain local procedures, work instructions, training matrices, and evidence of completion; support monitoring, audits, inspections, deviations, and corrective and preventive actions

Launch readiness and cross-functional delivery: Maintain the medical launch-readiness tracker and coordinate dependencies with Medical, Regulatory, Market Acces

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Entreprise
BridgeBio Inc.
Plateforme de publication
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