How You Will Achieve It:

• Provide guidance, lead/co-lead projects, manage own time to meet objectives and plan resource requirements for projects across the department.
• Communicate, plan, prioritize and deliver labeling documents according to company targets and submission requirements.
• Liaise and present information to all stakeholders using the most effective means of communication.
• Review request for labeling updates and appropriate implementation of defined content, recording the key decisions made.
• Support the use and development of current and new tools, technologies, and processes to support global label development, submission, and approval.
• Serve as an SME for the use of relevant tools and technologies within the course of the label development and translation process.
• Work within a framework of internal SOPs, working practices and external regulatory requirements, so that the high-quality delivery of outputs and compliance is maintained.
• Review and develop appropriate content for local labeling documents based on existing approved content, seeking strategic and medical input from others as required.
• Support the use of relevant tools and technologies within the course of the label development and translation process.
• Contribute to the development of continuous improvement of business practices associated with processes and tools.
• Advocate for new labeling initiatives to immediate labeling stakeholders (e.g., Labeling Teams).

Qualifications:

• Bachelor’s Degree (BA/BS) and 5+ years of experience.
• Knowledge of external labeling guidelines and regulations and internal labeling policies and procedures.
• Understand regulatory implications of product strategy with regards to the product label, assessment, and practical management of associated impacts.
• Demonstrated project management, attention to detail and problem solving skills.
• Excellent written and verbal communication skills essential.

Nice-to-Have:

• Master’s degree (MA/MBA/MS) and 3+ years of experience.
• Attention to detail and problem solving skills.
• Doctorate Degree (PhD/PharmD/JD).
• Demonstrated project management experience.
• Ability to negotiate, influence and problem solve.