Senior Global Regulatory Labeling Strategist

🕒 Outubro 16

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

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Parexel

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1983

💼 Consultoria

🏥 Saúde

📦 Logística

💰 Venture Round em 1990-01

Consulting • Healthcare • Logistics

Parexel é uma das maiores organizações de pesquisa clínica (CROs) do mundo, oferecendo serviços abrangentes para o processo de desenvolvimento clínico das Fases I a IV. A empresa é especializada em gestão de portfólio, gestão de ensaios clínicos, estratégia regulatória, acesso ao mercado e gestão do ciclo de vida para biofarmacêuticos. A Parexel busca acelerar a chegada de medicamentos que transformam vidas ao mercado, alavancando sua expertise clínica, regulatória e terapêutica. Com uma equipe global de mais de 21. 000 profissionais, a Parexel trabalha para integrar insights de pacientes e desenhos de estudo inovadores a fim de desenvolver tratamentos em áreas terapêuticas como oncologia, neurociência, doenças raras, entre outras. Seu foco está na condução de ensaios clínicos eficientes e centrados no paciente.

Descrição

• Provide strategic leadership and operational oversight for global labeling activities • Lead Target Product Label (TPL) development for early-stage assets • Develop and maintain Company Core Data Sheets (CCDS) • Develop regional labeling strategies and support US, EU, Rest of World, and other major markets • Develop labeling content, format, and accountability for regulatory submissions, including MAAs, supplements, and amendments • Ensure new labeling text meets regulatory labeling requirements • Support Rest of World labeling assessments against the CCDS and prepare Health Authority responses • Interface with project teams to ensure consistent labeling processes and local compliance with the CCDS • Communicate regulatory labeling strategy, risks, mitigation strategies, and plans to global leadership, project development teams, and senior management • Provide input into the end-to-end labeling process • Lead and manage labeling team meetings, driving strategic discussions and managing content • Provide coverage for other products during peak periods or team-member absences • Partner with stakeholders across Regulatory, Clinical, Safety, Medical, and Commercial functions • Contribute to medical and technical writing, ROW impact assessments, and cross-functional product-development decisions • Ensure compliant, high-quality labeling documentation throughout the product lifecycle

🎯 Requisitos

• Bachelor’s degree in Life Sciences or related field required • Advanced degree (MSc, PhD, PharmD) preferred • 7-10+ years in biotech/pharmaceutical industry • 5-7+ years in global labeling/regulatory with global strategic leadership responsibilities • Proven ability to lead cross-functional teams and influence stakeholders across diverse cultural and geographic settings • Strong knowledge of current global regulations, including vaccine development regulations and registration pathways • Previous experience in oncology or rare disease highly preferred • Strong experience with CTD format and content regulatory filings • Direct experience authoring, maintaining, and governing CCDS required, including ownership of global labeling updates and coordination of downstream implementation across regional labels • Delivery of labeling for at least one major application (NDA/BLA/MAA/JNDA, etc.) • Familiarity with RIMS (e.g., Veeva RIMS), eDMS (e.g., Veeva), Apollo, Docubridge, and Change Management systems (e.g., Trackwise) • Experience with Microsoft Office applications, SharePoint, Adobe Acrobat, TVT, Promomats, and GLAMS • Experience facilitating meetings and driving consensus and results • Excellent leadership, communication (verbal and written), and collaboration skills • Proven ability in medical/technical writing • Experience with TPL work for early development programs and identified life-cycle programs • Sense of urgency regarding FDA/EMA/MHRA/other health authority communications and response timelines • Integrity and high standards • Results orientation and strategic orientation • Flexibility/adaptability in varied situations and with diverse individuals and groups • Relationship building, teamwork, and cooperation • Fluency in English (verbal and written); additional languages are an asset • Candidates outside the EST time zone must have flexibility to provide coverage during EST hours

🏖️ Benefícios

• Equal opportunity employment consideration • Opportunity to work across diverse markets and therapeutic areas • Opportunity to shape global labeling strategy and lead governance processes • Collaborative, dynamic environment • Opportunity to contribute to innovative campaigns and improve patient access to accurate product information

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