Medical Affairs Lead
4 month contact with extension, 40 hours
Remote
$95-120 an hour DOE
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 play a pivotal role in driving medical strategy and 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.
Key Responsibilities:
- Launch Leadership: Drive the medical strategy and execution for the launch of GI products, working closely with cross-functional teams, including marketing, commercial, regulatory, and clinical development.
- Strategic Planning: 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: Develop and deliver 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: Lead medical communications efforts to disseminate relevant clinical and real-world evidence to support the product’s value proposition.
- Stakeholder Engagement: Build and maintain relationships with key opinion leaders (KOLs), healthcare professionals, and external stakeholders to ensure the scientific credibility of the product and maximize its impact on the market.
Qualifications:
- 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.
