Strategic Planning

• Strategic support and tactical medical affairs plan development throughout your product’s lifecycle
• Development of a cross-functional integrated communication strategy platform for effective product launch preparation
• Fractional operational support on an as-needed basis for medical information, publication planning, and/or grants management functions

Stakeholder Engagement

• Stakeholder identification, mapping, and engagement, including healthcare professional key thought leaders, patient advocacy organizations, and healthcare organizations

• Ongoing interaction and collaboration with healthcare professionals and patient advocacy organizations on your behalf

Medical Communication

• Planning and conduct of national and international medical advisory boards and expert meetings, both live and virtual, including selection of advisors, presentation development, and writing of summary outcomes reports

• Publication planning and project management for peer-reviewed journal articles and medical conference posters and presentations

• Act as the medical reviewer for promotional and non-promotional materials in partnership with your regulatory affairs and legal teams, providing expert scientific/medical consult to ensure accurate and compliant materials

• Planning and on-site operational support of medical affairs presence at national and international medical congresses

• Development and/or updating of medical information standard response documents

• Creation and maintenance of materials for reactive and proactive use by medical field teams, including slide decks and clinical trial summaries

Healthcare Compliance

• Development, review and/or updating of pragmatic global and regional policies and standard operating procedures (SOPs) for medical affairs, clinical development, and healthcare compliance functions

• Creation of live and transactional monitoring checklists to assess business activities such as advisory boards; grants, donations, and sponsorships; HCP educational support; HCP speaking events; and interactions with external stakeholders

• Development of internal training on healthcare compliance risks for medical affairs, commerical, and clinical research functions

• Drafting of country-specific healthcare compliance “reference guides” summarizing relevant laws and requirements for medical affairs and commercial activities

• Development of third-party due diligence as well as auditing and monitoring programs for life sciences companies of varying sizes