Pay rate: $25.00/hr
Work Hours: Monday-Friday, 8am-5pm
The Label Management Associate leverages technical expertise to consistently and accurately create investigational product label text that meets the needs of the study and is compliant with all applicable regulatory requirements. The Label Management Associate is responsible for providing input into supply planning activities through interaction and communication with Product Delivery/CTSP teams, creating label text, submitting the label request, and reviewing label proofs provided by external vendors. The Label Management Associate is also accountable for following all applicable quality and regulatory requirements in order to consistently and accurately deliver IP labels on-time and with quality.
Key Responsibilities:
- Track and communicate change/deviation management activities in the Label Management team
- Utilize Trackwise to write change controls and execute actions/steps related to change management and deviation management
- Gather and maintain metrics related to the Label Management Process
- Create and submit label requests for all Product Delivery/CTSP provided label
- Effectively collaborate with internal/external partners to provide compliant labels, on-time, for clinical trials
- Provide solutions to optimize implementation of the Product Delivery/CTSP master label approval process
- Follow all applicable quality and regulatory requirements
- Serve as Document Controller for uploading and routing documents
- Involvement with special projects and periodic reviews
- Stay abreast of cGMPs, CGCPs and other regulatory requirements related to the label process
- Additional responsibilities may include:
- Identify root causes when issues occur and develop, recommend, communicate and implement corrective actions and lessons learned
- Effectively plan for upcoming work and communicate to other groups (e.g., outsourcing, ELECTS), as needed
- Collecting and reporting metrics
- Coaching and mentoring of other less senior Label Management Associates
Requirements
Basic Qualifications:
- Bachelor's degree OR Associate degree
- Confident in abilities to learn new software applications
- Strong written and verbal communication skills in English
Nice to Have:
- Healthcare/pharmaceutical experience
- Knowledge of TrackWise
- Experience in a Clinical Trial Material Manufacturing and Services or related clinical role
- Strong record of performance
- Solid working knowledge of GCP regulations and GMP requirements
- Strong proficiency with computer applications including Microsoft Office products
- Demonstrated effectiveness in influencing across teams, management levels, and ability to work collaboratively
- Demonstrated effectiveness performing tasks requiring a strong attention to detail
- Strong interpersonal skills, including capability to engage in professional relationship building and networking
- Ability to translate study protocol elements and packaging design into a clearly defined plan for label text
- Knowledge and expertise working with QC in highly regulated area and relevant external experience, preferably within the industry
Benefits
Keywords provides all its contingent workforce with:
Medical, dental and vision benefits
Paid time off (including sick and select holidays)
401(k) enrollment with 3% employer matching
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law
Role Information: EN
Studio: Keywords Studios
Location: Indianapolis, IN
Area of Work: LMA
Service: QA
Employment Type: Contractor
Working Pattern: Full Time
This Organization Participates in E-Verify
Keywords Studios is committed to fair and ethical hiring practices. We expect candidates to conduct themselves with honesty and to participate in all applications and interviews independently, presenting their own knowledge and experience. Candidates should refrain from using AI assistance or third-party tools or services that could influence, capture, or otherwise interfere with the authenticity of the assessment process
Skills Required
- Bachelor's degree OR Associate degree
- Confident in abilities to learn new software applications
- Strong written and verbal communication skills in English
What We Do
Keywords Studios is an international technical and creative services provider to the global video games industry and beyond. We bring to life digital content that entertains, connects, challenges and educates people worldwide. Established in 1998, and now with more than 65 facilities in 22 countries strategically located in Asia, the Americas, Australia and Europe, we provide integrated art creation, marketing services, software engineering, testing, localization, audio and customer care services across more than 50 languages and 16 games platforms to a blue-chip client base of more than 950 clients across the globe.
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