Global Labeling Strategy Lead

Parexel; United States; Remote; USD 150,000 - 220,000; Full time

Job summary

Parexel is seeking a Senior/Global Regulatory Labeling Strategist to lead global labeling strategy across a diverse portfolio, from early development through lifecycle management. You will own Target Product Label development, CCDS, regional labeling strategies, and health authority responses, partnering with Regulatory, Clinical, Safety, Medical, and Commercial teams.

In this role, you will drive governance, manage labeling content, and ensure high-quality regulatory documentation across

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 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.
• Integrity, results orientation, strategic orientation, and effectiveness in cross-cultural collaboration.
• Adaptability and strong relationship-building with teammates and partners.

Responsibilities

• Global labeling experience to provide labeling strategy support across CCDS, US, EU, ROW, and other markets.
• Develop and maintain current knowledge of labeling regulations and industry standards for labeling and communicate requirements to stakeholders as needed.
• Lead the TPL development for early-phase assets.
• Develop labeling content, format and accountability for regulatory submissions (MAAs) and related supplements and amendments. Ensure that new labeling text meets regulatory labeling requirements.
• Support ROW labeling assessments against the CCDS and preparation of Health Authority (HA) responses.
• Interface with Project Teams to ensure consistency of labeling processes and local compliance with CCDS.
• Effectively communicate the regulatory labeling strategy, risks, mitigation strategies and overall plans to the Global Regulatory Science Leadership Team, Project Development Teams and senior management, as relevant.
• Provide input for the end-to-end labeling process.
• Ability to lead and manage labeling team meetings, driving strategic discussions and managing content.
• Provide coverage, as needed, on other products during peak periods or during absences of other team members.

Skills

Meeting facilitation

Leadership

Communication

Medical writing

Regulatory labeling

Global labeling strategy

Cross-functional collaboration

Strategic thinking

Attention to detail

Adaptability

Education

Bachelor’s degree in Life Sciences or related field

Advanced degree (MSc, PhD, PharmD) preferred

Tools

RIMS (Veeva RIMS)

eDMS (Veeva)

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, from early development through lifecycle management. You will own Target Product Label development, CCDS, regional labeling strategies, and health authority responses, partnering with Regulatory, Clinical, Safety, Medical, and Commercial teams.

In this role, you will drive governance, manage labeling content, and ensure high-quality regulatory documentation across