Remote, North Carolina, USA
5 days ago
Sr. Label Coordinator - North America (Remote)

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

We are seeking a Sr Label Coordinator to join our Global Clinical Supplies Team. This is a fully remote position, but candidate of choice must be located in the United States or Canada.

Role overview

Acts as a liaison and support to the local team in all areas of clinical supplies lifecycle (i.e., receipt, storage & handling, shipment & delivery, return & and accountability, destruction coordination) for assigned studies, ensuring compliance with requirements.

A day in the life:

Ensures all activities are driven in compliance with company good practices and client requirements.

Completes ongoing training on new regulations concerning clinical supplies and GxP activities.

Participates in and supports department project teams, including development clinical supply strategy.

Assists in the development and suggestion of improvements to update departmental SOPs.

May train or assist junior staff.

Plans and coordinates label, patient card, and dosing card activities.

Ensures activities are completed as needed according to PPD SOP requirements and/or client requirements.

Coordinates the preparation and regulatory approval of information to be included on labels, patient cards and dosing cards in clinical trials.

Reviews source documents and requests for quotes.

Assists with the development and maintenance of the Global Labeling Management tool as per SOP-CS-38 and the Translation Glossary.

Takes on complex projects.

Takes on Initiatives outside of project work such as process improvements, SMEs, training.

Providing cover for Manager during periods of absence (leave, sickness).

Keys to success: 

Education and Experience: 

High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 4 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 English and excellent communication skills both written and verbal.

Strong attention to detail.

Adaptive to changes.

Ability to use proper channels of communications to voice concerns and suggestions.

Basic digital literacy (Microsoft Word, Excel, Power Point, Internet Explorer), including keyboarding skills.     

Capable of working in a team environment as well as work independently with direct supervision.

Work Environment

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

Able to work upright and stationary for typical working hours.

Ability to use and learn standard office equipment and technology with proficiency.

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. 

May require travel.  (Recruiter will provide more details.) 

Salary Transparency

The salary range estimated for this position is $20-24/hr. This position will also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. Actual compensation will be confirmed in writing at the time of offer.

We offer a comprehensive Total Rewards package that our US colleagues and their families can count on, which generally include:

• A choice of national medical and dental plans, and a national vision plan

• A wellness program, and valuable health incentive opportunities for company contributions to a Health Reimbursement Accounts (HSAs) or Health Savings Account (HSA)

•Tax-advantaged savings and spending accounts and commuter benefits

• Employee assistance programs

• At least 120 hours paid time off (PTO). 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, short- and long-term disability, and volunteer rime off in accordance with company policy.

• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

Accessibility/Disability Access

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

EEO & Affirmative Action

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

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