CMC Technical Writer

Waltham, MA | Contract

Post Date: 03/28/2018 Job ID: 225814 Industry: Life Sciences

CMC Technical Writer



The Chemistry Manufacturing and Controls (CMC) Technical Writing function will support Regulatory Affairs and is responsible for the strategic planning and management of CMC submission projects in alignment with business goals, to facilitate achievement of corporate objectives.

Job Responsibilities:

• Develop and lead the execution of regulatory CMC submission.  

• Contribute to the definition of the CMC content requirements.

• Plan and manage document authoring resource needs for submission projects, and coordinate the authoring, review and approval of submission-ready documents.  

• Interpret and summarize complex data.  Independently serve as the primary author and lead writer for of CMC documents intended for submissions to Global Health Authorities using assigned templates and style guide.

• Ensure key messages are clear and consistent within and across documents.  Ensure the vocabulary is consistent throughout the submission.

• Develop  and foster constructive working relationships with internal and external colleagues

 

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