Label Management Associate

Keyword Studios
Indianapolis Indiana United States
11 days ago
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Please note that vaccination is not considered to be fully in effect until 14 days after the 2nd shot. There is also a 3-4 week waiting period between the 1st and 2nd shot.

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:

- Create and submit label requests for all Product Delivery/CTSP provided labels

- 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

- Additional responsibilities may include:

Requirements

Basic Qualifications:

Additional Skills/Preferences:

Benefits

KeyWords provides all its contingent workforce with:

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