The Compliance & Oversight Lead Manager is responsible for monitoring business processes, ensuring data quality and compliance, and supporting continuous improvement initiatives within the Global Labeling, Artwork & U.S. Advertising & Promotion (GLAAM) function. The role involves identifying trends, driving process improvements, supporting remediation activities, and providing guidance and support to internal stakeholders involved in labeling activities.
Key Responsibilities
Compliance, Process & Data Oversight
- Generate GLAAM project line listings and reports to support effective portfolio and resource management.
- Maintain GLAAM SharePoint pages and resources, including brand tracking, Global Labelling Lead (GLL) trackers, and therapeutic area lists.
- Support labelling processes through the creation and maintenance of business cases, job aids, work instructions, and process documentation.
- Conduct routine process and quality monitoring in line with agreed business plans and schedules.
- Support Quality Event (QE) investigations and remediation activities as required.
- Analyse regulatory and labelling system data to ensure accuracy, quality, and alignment with key business reports.
- Work with Subject Matter Experts (SMEs) to investigate and resolve data discrepancies.
- Monitor business process performance and identify trends, risks, and opportunities for improvement.
- Coordinate departmental initiatives aimed at enhancing labelling and regulatory processes.
- Support the implementation of process improvements and efficiency initiatives.
- Provide data-driven insights and recommendations to project leaders and key stakeholders.
Required Qualifications
Education
- Bachelor's Degree or equivalent experience.
- Degree in Regulatory Affairs or related discipline desirable.
Experience
- 3-8 years' experience within a global or multinational pharmaceutical environment.
- Previous experience within Labelling and/or Regulatory Affairs preferred.
- Ability to work independently and manage multiple priorities effectively.
- Demonstrated project management and project coordination experience.
- Proven track record of delivering high-quality work to agreed timelines.
- Strong written and verbal communication skills.
- Experience supporting continuous improvement initiatives is desirable.
Technical Skills
- Strong project management, coordination, and facilitation skills.
- Excellent verbal and written communication abilities.
- Strong analytical and problem-solving capabilities.
- Ability to manage medium-complexity projects and adapt to evolving business needs.
- Experience analysing and manipulating data to support decision-making.
- Ability to synthesise complex data and processes into clear conclusions and actionable insights.
- Knowledge of communication, process design, and continuous improvement tools desirable.
- Ability to evaluate, diagnose, and improve business processes and systems.
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Compliance and Oversight Lead Manager employer: SRG
As a Senior Clinical Trial Manager at our company, you will thrive in a dynamic and collaborative work environment that prioritises innovation and employee development. We offer competitive benefits, a strong focus on professional growth, and the opportunity to work alongside industry leaders in a location renowned for its commitment to advancing clinical research. Join us to make a meaningful impact in the field of clinical trials while enjoying a supportive culture that values your contributions.
