EU Medical Operations Lead - Oncology

Proclinical has partnered with a biopharmaceutical company in search for a talented Medical Operations Lead. You will be the key contact point for Early Access Programs, you will also be expected to set up Medical Information policies and support medical communications and publications.

Job Responsibilities

• Be a member of the Early Access or Name Patient Programs working group
• Act as key central contact for external partner(s) executing Early Access or Name Patient Programs
• Lead Medical Process Development, coordination & optimization; identify and manage new technologies for communication of medical content in collaboration with Commercial Excellence
• Responsible for providing input into Medical affairs dashboards (global, regional) and developing/ maintaining EU medical affairs dashboard as applicable
• Ensure all Medical Information policies and processes are in alignment with Stemline global policies as well as best industry practices, and applicable laws and regulations
• Ensure that unsolicited medical information requests are answered by liaising with external vendor, in consultation with Medical, QA, Safety, RA as required, and tracking is followed according to Stemline's SOPs
• Maintain version control for Medical Affairs Field Team materials for facilitating conversations with HCPs
• Ensure medinfo readiness (as defined by s global SOP) for regular internal and external audits and inspections
• Support the Medical Lead Europe to develop publication strategy, publication outreach and liaising with external vendors and KOLs; maintain version control
• Supports and represents the Medical Lead Europe at PRC meetings
• Attend medical congress to assist with medical affairs booth
• Work with Legal and Compliance to ensure accurate tracking of aggregate spend (Sunshine Act) when necessary
• Responsible to comply with all obligations defined by international and local laws and regulations, acts as a resource of advice to others

Skills and Requirements

• Diploma in project management or equivalent, business administration, or pharmacy
• 10+ years' relevant experience in Medical Affairs roles with a strong background in running or setting up Medical Operations
• Start-up and clinical trial experience are a plus
• Fluency in English required, other European language(s) are a plus

To Apply

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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