(US - REMOTE) Global Labeling Lead Consultant - CCDS, SmPC, USPIs

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 Excellent communication and interpersonal skills Proven problem-solving skills and ability to make sound decisions under pressure Demonstrated ability to manage regulatory activities and deliver against project timelines Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) Excellent oral and written communications skills Ability to build cross-functional relationships and work collaboratively

Responsible for initial creation and updates to labeling documents Drive strategy through guidance and advising of the Labeling Team Ensure impact on Country Labeling Documents is considered during labeling discussions Advise on content of other labels in the same therapeutic class Ensure compliance with regulatory requirements and deliver high-quality labeling solutions Provide strategic support and leadership to the labeling team Guide the labeling team to develop and maintain Company Core Data Sheets (CCDS), Package Inserts (PI), Summary of product Characteristics (SPC), and patient labeling documents Keep up-to-date with labeling guidelines and regulations related to US and EU labeling Provide project management to the labeling team throughout the process Set clear target and prioritization plans, ensuring deliverable remain on target Act as the primary point of contact for labeling team members and provide direction to Labeling Operations Managers Act as a reviewer and approver of labeling documents Ensure adherence to relevant regulatory guidelines (FDA, EMA, ICH) Collaborate closely with cross-functional teams (Regulatory Affairs, Clinical Operations, Quality Assurance, Manufacturing) Monitor industry trends and regulatory changes related to pharmaceutical labeling Collaborate with clients and provide expert advice and guidance on labeling requirements Contribute to business strategy discussions and implement objectives Lead strategic initiatives and develop implementation plans Participate in preparing bid developments for new clients Identify opportunities for business growth Prepare and present client metrics Train and provide guidance to other GLLs