Senior Global Labeling Strategy Architect

Parexel; Boise (ID); On-site; USD 150,000 - 210,000; Full time

Job summary

Parexel is seeking a Senior/Global Regulatory Labeling Strategist to lead global labeling strategy across a diverse portfolio of therapies. This role spans from early development through post-approval lifecycle, owning TPL development, CCDS, and regional labeling strategies.

You will collaborate with Regulatory, Clinical, Safety, Medical and Commercial teams worldwide to ensure compliant, high-quality labeling documentation across markets and lifecycle stages.

Qualifications

• Experience facilitating meetings and driving consensus and results.
• Excellent leadership, communication (verbal and written) and collaboration skills.
• Proven ability in medical/technical writing.
• Labeling experience (CCDS, US, EU, UK, other major markets) in rare diseases, oncology and/or vaccines is desirable.
• Experience with TPL work for early development programs and identified life-cycle programs.
• Sense of urgency regarding FDA/EMA/MHRA/other HA communications and response timelines to provide coverage for product approvals and labeling negotiations.

Responsibilities

• Provide global labeling strategy and ownership of CCDS and regional labels.
• Lead the TPL development for early-phase assets.
• Develop labeling content and regulatory submission materials.
• Support ROW labeling assessments against the CCDS and preparation of Health Authority responses.
• Coordinate with Regulatory, Clinical, Safety, Medical and Commercial teams.
• Lead governance committees and report to leadership on labeling strategy and risks.
• Ensure timely and compliant labeling documentation across the product lifecycle.
• Cover for the team during peak periods or absences.
• Manage labeling team meetings and drive strategic discussions and decisions.
• Stay updated on global labeling regulations and standards.

Skills

Leadership

Regulatory strategy

Global labeling

Medical writing

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences

Tools

Veeva RIMS

Veeva eDMS

APOLLO

Docubridge

TrackWise

Microsoft Office

SharePoint

Adobe Acrobat

TVT

Promomats

GLAMS

Job description

Parexel is seeking a Senior/Global Regulatory Labeling Strategist to lead global labeling strategy across a diverse portfolio of therapies. This role spans from early development through post-approval lifecycle, owning TPL development, CCDS, and regional labeling strategies.

You will collaborate with Regulatory, Clinical, Safety, Medical and Commercial teams worldwide to ensure compliant, high-quality labeling documentation across markets and lifecycle stages.