Description
The Label Management Associate will leverage 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 successful candidate will be responsible for tracking and communicating change/deviation management activities in the Label Management team, utilizing Trackwise to write change controls and execute actions/steps related to change management and deviation management.
Key responsibilities include gathering and maintaining metrics related to the Label Management Process, creating and submitting label requests for all Product Delivery/CTSP provided label, and effectively collaborating with internal/external partners to provide compliant labels, on-time, for clinical trials.
Additional responsibilities may include identifying root causes when issues occur and developing, recommending, communicating, and implementing corrective actions and lessons learned.
The ideal candidate will have a Bachelor's degree or Associate degree, confident in their ability to learn new software applications, and strong written and verbal communication skills in English.
Nice to have qualifications include healthcare/pharmaceutical experience, knowledge of TrackWise, experience in a Clinical Trial Material Manufacturing and Services or related clinical role, and strong record of performance.
Benefits include medical, dental, and vision benefits, paid time off, and 401(k) enrollment with 3% employer matching.