REMOTE Global Labeling Lead Consultant - CCDS, SmPC, USPIs

Job Description

ClinChoice is seeking a Global Labeling Lead Consultant to work directly with a major pharmaceutical client on a 12-month contract basis. This role offers a remote work option and the stability of working for a global CRO. The Global Labeling Lead (GLL) will be responsible for the creation and updates of labeling documents for assigned projects, driving strategy, and advising the Labeling Team on internal labeling guidance and policies. The GLL will ensure compliance with regulatory requirements and deliver high-quality labeling solutions.Role involves:

• Providing strategic support and leadership to the labeling team.
• Guiding the team in developing and maintaining Company Core Data Sheets (CCDS), Package Inserts (PI), and Summary of Product Characteristics (SPC).
• Keeping up-to-date with labeling guidelines and regulations related to US and EU labeling.
• Managing projects from request to stakeholder notification.
• Acting as the primary point of contact for the labeling team.
• Reviewing and approving labeling documents.
• Collaborating with cross-functional teams.

Requirements:

• Bachelor's degree in a scientific or related field.
• Minimum 7 years of experience in pharmaceutical labeling operations.
• Strong knowledge of regulatory requirements and guidelines (FDA, EMA, ICH).
• Demonstrated knowledge of CCDS and labeling team objectives.
• Excellent project management skills.
• Strong attention to detail and accuracy.
• Effective leadership and communication skills.
• Proficiency in Microsoft Office Suite.

Role offers:

• Opportunity to work directly with a single sponsor.
• Security and career opportunities of a global CRO.
• Remote work option.