Sr Label Coordinator (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

PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

We are seeking a Sr Label Coordinator to join our Global Clinical Supplies Team. The role can be based in Spain, Croatia, France or Ireland.

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).

making recommendations.

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.)

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.