Label Management Associate

Keywords Studios
December 20, 2023
Offerd Salary:Negotiation
Working address:N/A
Contract Type:Other
Working Time:Negotigation
Working type:N/A
Ref info:N/A

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 and 5+ years of healthcare/pharmaceutical experience
  • Knowledge of TrackWise
  • Nice to Have:

  • 3 years experience in a Clinical Trial Material Manufacturing and Services or related clinical role
  • Ability to translate study protocol elements and packaging design into a clearly defined plan for label text
  • 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
  • Strong written and verbal communication skills
  • Demonstrated effectiveness performing tasks requiring a strong attention to detail
  • Strong interpersonal skills, including capability to engage in professional relationship building and networking
  • Must be fluent in English
  • 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
  • From this employer

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