REMOTE Global Labeling Lead Consultant - CCDS, SmPC, USPIs

Job Description

ClinChoice is seeking a Global Labeling Lead Consultant for a 12-month remote contract. In this client-facing role, the consultant will be responsible for the initial creation and updates to labeling documents for assigned projects. They will drive strategy by advising the Labeling Team on internal guidance and policies, raising awareness of key factors when revising labels, and ensuring consideration of the impact on Country Labeling Documents.

• Providing strategic support and leadership to the labeling team.
• Guiding the team to develop and maintain CCDS, Package Inserts, SPC, and associated patient labeling documents.
• Keeping up-to-date with labeling guidelines and regulations related to US and EU labeling.
• Providing project management to the labeling team.
• Acting as the primary point of contact for the labeling team members.
• Acting as a reviewer and approver of labeling documents.
• Collaborating with cross-functional teams.
• Monitoring industry trends and regulatory changes.
• Collaborating with clients and providing expert advice.
• Producing quality work that meets or exceeds client expectations.
• Contributing to business strategy discussions.
• Leading strategic initiatives and developing implementation plans.
• Participating in preparing written and presented bid developments for new clients.
• Identifying opportunities for business growth.
• Preparing and presenting client metrics as needed.
• Training and providing guidance to other GLLs as needed.

Requirements:

• Bachelor's degree in a scientific or related field (Advanced degree is a plus).
• Minimum 7 years of experience in pharmaceutical labeling operations within a pharmaceutical industry setting.
• Strong knowledge of regulatory requirements and guidelines related to pharmaceutical labeling (FDA, EMA, ICH).
• Demonstrated knowledge and understanding of CCDS and the labeling team purpose and objectives.
• Ability to liaise with stakeholders.
• Excellent project management skills.
• Strong attention to detail and accuracy.
• Effective leadership and team management abilities.
• Proven problem-solving skills.
• Demonstrated ability to manage regulatory activities and deliver against project timelines.
• Proficiency in using Microsoft Office Suite.
• Excellent oral and written communications skills.

ClinChoice offers:

• Opportunity to work directly for a single sponsor while having the security and career opportunities of a global CRO.
• A focus on quality, professional development, and a supportive culture.