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
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Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).
In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
- 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
Working Conditions and Environment:
- Work may be performed in a production, office or home-based environment with exposure to electrical office equipment.
- Rarely travels both domestic and international
Physical Requirements:
- 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.