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