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Smith+Nephew · 4 hours ago

Senior Manager – Global Clinical Strategy (Pittsburgh, PA)

Pittsburgh, PA

Full-time

Hybrid

Mid, Senior Level

$130K/yr - $175K/yr

7+ years exp

Smith+Nephew is a company dedicated to crafting and manufacturing technology that enhances living. The Senior Manager of Global Clinical Strategy will lead the development and execution of clinical and economic evidence strategies to support market access and new product development within the Orthopaedics sector, specifically focusing on the Hips and T&E franchises.

Medical Device

Comp. & Benefits

Responsibilities

Responsible for crafting and driving high impact pivotal initiatives across the Orthopaedics portfolio. Partner with Global and Regional Marketing, Regulatory, Market Access and external partners, and build evidence strategies including claims, publication strategy and conference submissions to generate clinical and health economic evidence to expedite market access and expand market adoption for Smith + Nephew products in the Ortho Hips & T&E franchises

Supports new product development teams for the Ortho Hips and T&E to ensure timely evidence strategy development and execution, as well as clinical support for regulatory submissions to support regulatory approvals of the products in key markets where applicable

Develops clinical strategies to ensure MDR readiness and compliance, working closely with Global Clinical and Medical Affairs functions to align on evidence sufficiency. Drive and lead execution of PMCF activities and timely reporting to remain on schedule for MDR technical file submissions, Notified Body commitments, and audit readiness

Support the development and implementation of strategic engagement and partnership in research with KOLs and research centers

Participation in internal/external Global Clinical Strategy-related audits, and regulatory inspections as needed; Implement appropriate corrective and preventative actions (CAPA), if necessary

Presents progress and results to internal stakeholders at all levels of the organization

Contributes to development or updates of department standard operating procedures (SOPs), business processes, and policies

Support regulatory documentation for new or existing products, as applicable. This may include development of responses for clinical-related questions received from regulatory authorities

Ensure compliance to applicable processes, quality standards and regulations

Attend professional conferences and surgeon training labs as appropriate

Team Management, business needs gathering, stakeholder alignment, budget management and reporting

Oversight and direct support of Ortho Hips and T&E portfolio of clinical activities and deliverables, including external liaison with KOLs and clinical consultants

Qualification

Clinical strategy developmentMarket access strategiesRegulatory complianceOrthopedic experienceScientific writingStakeholder alignmentMicrosoft Office proficiencyTeam managementTime managementNegotiation skillsPresentation skills