Medical Affairs Lead
3 weeks ago
Medical Affairs Lead
Remote
Overview:
We are looking for a highly skilled and strategic Medical Affairs Product Launch Lead to join the US Medical Affairs Gastroenterology team. This individual will support medical strategy and lead executing the launch of key GI products. The ideal candidate will possess deep experience in medical affairs with a focus on product launch, and have a strong ability to work cross-functionally with internal and external stakeholders to ensure successful launch execution.
Responsibilities:
- Launch Leadership: Support the medical strategy and drive execution for the launch of GI products, working closely with cross-functional teams, including marketing, commercial, regulatory, and clinical development.
- Strategic Planning: Co-develop and implement medical affairs plans in alignment with the overall brand strategy, ensuring that medical initiatives support the commercial and clinical objectives of the GI product.
- Cross-functional Collaboration: Serve as the primary medical liaison to commercial teams, ensuring alignment on key messaging, data dissemination, and educational initiatives for healthcare professionals.
- Material Review and Approval: Lead the review and approval of promotional, educational, and scientific materials to ensure medical accuracy and compliance with industry standards.
- Training and Education: Co-shape internal medical training for field-based teams and external educational programs, including advisory boards and national medical education initiatives.
- Advisory Board Leadership: Plan, organize, and lead medical advisory boards, gathering key insights from thought leaders to shape ongoing strategy and execution.
- Post-Marketing and Regulatory Support: Collaborate with regulatory and clinical teams to ensure post-marketing commitments and safety surveillance activities are executed in compliance with FDA guidelines.
- Data Dissemination: Support medical communications efforts to disseminate relevant clinical and real-world evidence to support the product’s value proposition.
Qualifications:
- Experience:
- 8+ years of Medical Affairs experience, with at least 3-5 years focused on product launch in the pharmaceutical industry.
- Proven track record of leading medical strategies for the successful launch of GI or other therapeutic products.
- Deep understanding of medical affairs processes, including medical material review, advisory boards, and KOL engagement.
- Preferred: Experience in Gastroenterology (GI) or Immunology is highly desirable.
- Preferred: Experience with FDA post-marketing commitments or real-world evidence generation.
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