Work Schedule

Environmental Conditions

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

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.