US-MA, Director, Non-Clinical Writing 1601968-MZ
Please note that the requirements specified in this posting are the basic qualifications required for the Director, Non Clinical Writing position; however, job title will be dependent on the candidate's level of experience in those requirements.
We have a challenging opportunity for a Director, Non Clinical writing group based in Cambridge, MA, reporting to the Senior Director, Global DMPK head of Strategy and Operations.
The candidate will provide global nonclinical strategic direction and leadership to a group of writing and documentation staff. Candidate will possess strong knowledge of GxP and experience in regulatory submission processes, writing, and nonclinical content. In this leadership role, the candidate will be responsible for working cross-functionally to develop and implement global strategies, operational plans, and innovative solutions for nonclinical writing activities. The candidate will interface with external groups including global DMPK, Toxicology, Pharmacology, Regulatory, Clinical, Quality, and Publishing to implement strategies and initiatives. The candidate will have a strong understanding of the day-to-day responsibilities of the group and the various functional interdependencies related to submission management.
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