Global Labeling Strategy Leader

Parexel; Oregon; Hybrid; USD 150,000 - 190,000; Full time

Job summary

Parexel is seeking a Senior/Global Regulatory Labeling Strategist to lead global labeling strategy across CCDS, US, EU, and ROW. You will own TPL development for early assets, contribute to regulatory submissions, and engage with cross-functional teams worldwide to ensure compliant labeling across markets.

The role requires strong leadership, medical writing expertise, and extensive knowledge of CTD formats, with a focus on oncology/rare diseases preferred. EST time-zone coverage is advantageous.

Qualifications

• Experience leading global labeling strategy across CCDS, US, EU, ROW and major markets.
• Proven medical/technical writing demonstrated in regulatory submissions.

Responsibilities

• Provide strategic leadership for global labeling activities across assets from early development through lifecycle

Skills

Leadership

Regulatory strategy

Global labeling

Cross-functional teamwork

Medical writing

CTD knowledge

Strategic thinking

Education

Bachelor's degree in Life Sciences

Advanced degree preferred (MSc/PhD/PharmD)

Tools

RIMS (Veeva)

eDMS (Veeva)

Apollo

Docubridge

Trackwise

Microsoft Office

Job description

Parexel is seeking a Senior/Global Regulatory Labeling Strategist to lead global labeling strategy across CCDS, US, EU, and ROW. You will own TPL development for early assets, contribute to regulatory submissions, and engage with cross-functional teams worldwide to ensure compliant labeling across markets.

The role requires strong leadership, medical writing expertise, and extensive knowledge of CTD formats, with a focus on oncology/rare diseases preferred. EST time-zone coverage is advantageous.