Job Description

The Global Pack Management (GPM) Team within Clinical Supply Chain Packaging Operations is responsible for:
a) The creation and sourcing of secondary packaging components for all products to be packaged internally within Sponsor ’s clinical trial arena.
b) The management and control of all label content regulatory requirements and translations within the SMART LS label creation system for all countries/languages where clinical trials are held
c) The creation and approval of all label content for clinical trial labels across multiple modalities', liaising within 60 plus countries globally, as well as interfacing with Sponsor’s Clinical Interface/CTSM team to determine delivery timescales.
This role is specifically recruiting for an External Label Specialist within Global Pack Management who will be tasked with the creation and approval of label content for third parties for the following modalities:
 Vaccines
 Pharmaceuticals (supplies packed external to Sponsor)
The External Label Specialist will liaise with the Clinical Interface/CTSM teams to create the label content and liaise with multiple third party manufacturing/ packaging companies to create and approve the final Clinical Trial labels, using Sponsor Systems such as SMART LS and Prisym.
The approved labels will be used for labeling clinical trial supplies packaged at third parties. In addition, the role will have opportunity to cross train in a number of additional areas within GPM.
This position will work within a global team....

Key Responsibilities: List activities that comprise the job including aspects of budget control, people management,
technical activities, health & safety, GMP and individual specific activities.
 Working within a global team, create master label content according to existing processes and procedures specific to each modality
 Liaise with third party contract manufacturing/ packaging companies to provide label content and receive labels created by the third parties

 Perform quality critical checks of label content produced in various languages within the required timelines
 Creation of label documentation, required for in-country regulatory submissions, in a timely manner
 Perform the translation management role within SMART LS, liaise with third party translation providers
 Identify opportunities for process improvement
 Ensure quality right first time across all elements of the label creation process
 Participate in quality investigation activities (Root Cause Analysis, Product Impact Assessment, Mitigation Action definition), potential to become a business lead investigator
 Own and implement corrective and preventive actions (CAPAs)
 Motivated to self-assign core tasks, prioritizing and completing as part of a wider team with minimal supervision/ input
 Work with external vendors, such as translation service provider and third party clinical trial label approvers
 Participate in department improvement projects, identify process improvements
 Participate in GPM team meetings
 Liaise with other groups within Clinical Supply Chain such as Clinical Interface/CTSM and Quality Assurance

Competencies:
Include breadth & depth across disciplines or functions; behaviours and expertise in field
 Understanding of cGMP requirements and regulatory requirements
 Proficient in Microsoft package and Adobe tools
 Ability to work between multiple GMP IT software systems, adapt to changing systems
 Ability to follow written instructions
 The ability to work effectively with others to meet timelines, business goals and objectives.
 Excellent verbal and written skills
 Ability to work individually as well as part of a team
 Ability to challenge the status quo
 Capacity to work in a cross cultural environment
 detailed oriented, high quallity minded

Must have ( if not, please do not apply)

GMP experience, pack and label experience, very well versed with computer systems, able to detect errors, compare documents, follow procedures, must go onsite Collegeville, Philadelphia

Minimum 3-5 years experience

Education

Computer or scientific training 

Compensation:

Full benefits package : Salary beetween 70 000$ to 80 000$ 

What we offer

At Keyrus, thanks to the expertise of our people and external partners, each employee is welcomed with a varied integration program. You will join a dynamic and international environment with enthusiastic and professional colleagues.

We invest considerable time and resources in training our staff (technical and non-technical courses) to support you in your continuous personal and professional growth. On top of this, you will receive a complete salary package including attractive extra-legal benefits ( pension and health insurance, …) based on your background and experience.

Who we are

Keyrus Life Science is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our human approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.

At Keyrus Life Science we’re proud of our commitment to deliver services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better.

From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.