Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

We have a vacancy for a Label Development Specialist in our Global Clinical Supplies Team (CRG). This role can be office based, homebased or Flex.

Overview of role:

Provides complete oversight to the local team for complex global clinical trials. Ensures clinical supplies activities linked to the Label Development Team follow company and client requirements. May act as a representative and lead for the Label Development department on all assigned projects.

A day in the life:

• Develops early-stage label strategy for all global clinical trials based on: (i.e., processed award notifications, services required, countries involved, submission timelines)
• Meets with internal teams to coordinate efforts, provide recommendations and risks, and develop initiatives for timeline effectiveness
• Represents the Label Development Team department internally and externally at meetings, strategic projects, and initiatives as per the business requirements
• Pro-actively works on process improvement initiatives
• Evaluates Label Development team activities to optimize resources and meet project medium-complex deadlines
• Participates in Client-facing calls to assist other Label Development team members
• Mentors and supports junior team members

• Intermediate medical/therapeutic area knowledge, solid understanding of medical terminology and all types of Clinical Labels, Patient Cards and other patient facing materials
• Strong interpersonal, planning, organizational, problem solving, sense of urgency and decision-making skills
• Demonstrated effective leadership and team building skills
• Strong Project Management skills
• Strong focus on customers and attention to detail
• Ability to work in team environment, as well as work independently with moderate guidance
• Basic understanding of clinical supply operations

• Work may be performed in a production, office or home-based environment with exposure to electrical office equipment.
• Rarely travels both domestic and international

• Frequently stationary for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Frequent mobility required.
• Occasional crouching, stooping, bending and twisting of upper body and neck.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
• Frequently interacts with others to obtain or relate information to diverse groups.
• Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration.
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
• Regular and consistent attendance.