Project Manager_Scientific I (Assistant)

REMOTE POSSIBLE
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Job Summary
Qualifications:

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Bachelor’s degree in project management or a scientific field, or relevant work experience required, Master’s preferred.
Minimum of 3 years job-related pharmaceutical/biological experience in a laboratory setting, project management, labeling, regulatory or relevant professional experience.
Must have strong communication (oral and written), organizational, and project management skills; above average proficiency in Microsoft applications (Word, Excel, PowerPoint,); ability to make a positive contribution as demonstrated by learning new skills and working well both independently and in a team environment. *

Responsibilities:
*Under general supervision of manager or director, coordinates timing and compliance of labeling-related activities and deliverable within the oncology therapeutic area.

Primary activities include, but are not limited to:
Managing timelines for oncology filings, including partnerships; managing documentation of communications within the BDLM system; managing tracking sheets for regulatory milestones, safety label updates, and agency correspondence; providing updates to competitor labeling information; communicating updates within the oncology team lists to the official master team lists on a quarterly basis; communicating updates to labeling timelines to other parts of the organization; tracking timelines for amendments to supplements under FDA review.
Manager open to Rahway NJ or Upper Gwynedd PA Candidates.

Comments/Special Instructions
Remote work available

Contract Length:

• More than 1 year