Labelng Operations Specialist

Bachelor’s degree in a science or life sciences required

2-4 years experience in a regulated environment; pharmaceutical labeling experience preferred.

• Knowledge of global/regional regulatory guidelines and requirements important.
• Excellent written and verbal communication skills essential.
• Complete fluency in English Language.
• Proven strength in logical, analytical and writing ability essential.
• Demonstrated project management skills and attention to detail required.
• Identifies and resolves problems in a proactive manner.
• Has strong knowledge/understanding of the principles and concepts of the discipline

• Ability to assess and manage project timelines.
• Ability to multi-task, prioritize and manage multiple projects.
• Ability to identify and resolve problems in a proactive manner.
• Demonstrates appropriate decision making including issue escalation to the Global Labeling Lead (GLL) and other appropriate stakeholders.
• Works under general supervision. Performs assignments using established procedures and general instruction on the process and desired outcome
• Participates and contributes as a team member
• Ability to liaise with stakeholders using effective means of communication.
• Clear and effective written and verbal communication skills.
• Makes decisions to resolve moderately complex problems in standard situations
• Makes decisions within guidelines and policies
• Able to work in ambiguous situations as part of a Work Team
• Decisions have short-term effect on the delivery of scheduled programs/projects
• Uses own judgment judgment to modify standard methods and techniques when necessary
• Ability to apply labeling regulatory guidance on formatting requirements.
• High attention to detail.
• Ability to consolidate comments from multiple sources (e.g., emails, meeting minutes).
• Applies technical skills and Work Team knowledge to achieve assigned work on projects/assignments
• May act as a technical resource within own Work Team
• Understands the fundamental business drivers for the company
• Uses this knowledge in own work
• Must have excellent computer skills and be proficient with Microsoft Word and similar applications.
• Prepare submission ready documents.
• Physical demands: Available for regional or global travel 5-10% of the time including overnight stays as necessary consistent with project needs and office location.
• Work environment: Office environment or remote.
• Learn more about our EEO & Accommodations request here.