Apply📍 Canada
🧭 Contract
🔍 Pharmaceutical
- 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, including FDA, EMA, and ICH guidelines.
- Demonstrated knowledge and understanding of CCDS and the labeling team purpose and objectives.
- Ability to liaise with stakeholders.
- Excellent project management skills, with the ability to prioritize tasks, manage timelines, and handle multiple projects simultaneously.
- Strong attention to detail and accuracy, with a focus on delivering high-quality labeling solutions.
- Effective leadership and team management abilities, with excellent communication and interpersonal skills.
- Proven problem-solving skills and the ability to make sound decisions under pressure.
- Demonstrated ability to manage regulatory activities and deliver against project timelines.
- Proficiency in using Microsoft Office Suite (Word, Excel, PowerPoint).
- Excellent oral and written communications skills as well as the ability to build cross-functional relationships and work collaboratively with other groups.
- Provide strategic support and leadership to the labeling team, providing guidance, coaching, and feedback.
- Guide the labeling team to develop and maintain Company Core Data Sheets (CCDS), Package Inserts (PI), Summary of product Characteristics (SPC), and their associates patient labeling documents.
- Keep up-to-date with labeling guidelines and regulations related to the development and maintenance of US and EU labeling.
- Provide project management to the labeling team throughout the process from request to stakeholder notification.
- Set clear target and prioritization plans, ensuring that labeling teams are aware of the require timelines so that deliverable remain on target to team internal and external deadlines.
- Act as the primary point of contact for the labeling team members and provide day-to-day direction to Labeling Operations Managers so labeling can be prepared and managed appropriately.
- Act as a reviewer and approver of labeling documents ensuring that content complies with regulatory requirements and guidelines, and company policies and procedures.
- Ensure adherence to relevant regulatory guidelines, such as FDA, EMA, and ICH, throughout the labeling process.
- Collaborate closely with cross-functional teams, including Regulatory Affairs, Clinical Operations, Quality Assurance, and Manufacturing, to ensure smooth and timely execution of labeling activities.
- Monitor industry trends and regulatory changes related to pharmaceutical labeling, and proactively implement necessary updates and improvements to labeling processes.
- Collaborate with clients and provide expert advice and guidance on labeling requirements, best practices, and compliance matters.
- Produces quality work that meets or exceeds client expectations.
- Contribute to business strategy discussions and implement regional and global specific objectives, as appropriate.
- Lead strategic initiatives and develop implementation plans taking ownership for final results and implementing process improvements where needed.
- Participates in preparing written and presented bid developments for new clients.
- Identify opportunities for business growth to ensure on going client support and positive engagement
- Prepare and present client metrics as needed.
- Train and provide guidance to other GLLs as needed.
LeadershipProject ManagementProject CoordinationCross-functional Team LeadershipCommunication SkillsAnalytical SkillsCollaborationMentoringAttention to detailTime ManagementWritten communicationDocumentationComplianceMicrosoft Office SuiteInterpersonal skillsExcellent communication skillsProblem-solving skillsMS OfficeNegotiation skillsTrainingClient relationship managementTeam managementStakeholder managementStrategic thinkingData analyticsData management
Posted 22 days ago
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