Senior Global Labeling Strategy Lead

Parexel; Topeka (KS); On-site; USD 150,000 - 190,000; Full time

Job summary

Parexel is seeking an experienced Senior/Global Regulatory Labeling Strategist to guide global labeling strategy across an innovative portfolio. You will own TPL development for early assets, CCDS, and regional labeling strategies, collaborating with Regulatory, Clinical, Safety, Medical, and Commercial teams to deliver compliant labeling across markets.

You will influence product development and lifecycle decisions, lead governance committees, and provide strategic direction for health

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 lifecycle programs.

Responsibilities

• Global labeling experience to provide labeling strategy across CCDS, US, EU, ROW, and other major markets.
• Develop and maintain current knowledge of labeling regulations and industry standards for labeling and communicate requirements to stakeholders.
• Lead the TPL development for early-phase assets.
• Develop labeling content, format and accountability for regulatory submissions (MAAs) and related supplements and amendments.
• Support ROW labeling assessments against the CCDS and HA responses.
• Interface with Project Teams to ensure consistency of labeling processes and local CCDS compliance.
• Communicate the labeling strategy, risks, and plans to leadership and stakeholders.
• Provide input for end-to-end labeling process.
• Lead labeling team meetings and drive strategic discussions.

Skills

Global labeling strategy

Leadership

Medical/technical writing

Regulatory strategy

Cross-functional collaboration

Education

Bachelor’s degree in Life Sciences or related field

Advanced degree (MSc/PhD/PharmD) preferred

Tools

RIMS (e.g., Veeva)

eDMS (Veeva)

Job description

Parexel is seeking an experienced Senior/Global Regulatory Labeling Strategist to guide global labeling strategy across an innovative portfolio. You will own TPL development for early assets, CCDS, and regional labeling strategies, collaborating with Regulatory, Clinical, Safety, Medical, and Commercial teams to deliver compliant labeling across markets.

You will influence product development and lifecycle decisions, lead governance committees, and provide strategic direction for health