Label Management Associate
Posted on Sep 27, 2024 by Keywords Studios
Indianapolis, IN
Other
Immediate Start
Annual Salary
Contract/Project
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
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
Reference: 202575514
https://jobs.careeraddict.com/post/95612149
Label Management Associate
Posted on Sep 27, 2024 by Keywords Studios
Indianapolis, IN
Other
Immediate Start
Annual Salary
Contract/Project
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
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
Reference: 202575514
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