Harmony Biosciences is hiring: Technical Editor, Regulatory Affairs in Plymouth

3 days ago Requisition ID : 1421

Harmony Biosciences is recruiting for a Technical Editor, Regulatory Affairs in our Plymouth Meeting, PA location. In this role you will be accountable for technical editing of high-quality regulatory documents across the clinical development portfolio at Harmony. This includes, but is not limited to, copyediting and pre-publishing checks of all documents that are part of a regulatory submission. Additional responsibilities will include support of the electronic document management system (EDMS) ClinicalTrials.gov postings.

Responsibilities include but are not limited to :

• Manages all technical aspects of regulatory documents including, but not limited to, Clinical Study Protocols, Clinical Study Protocol Amendments, Clinical Study Reports, Statistical Analysis Plans, Investigational New Drug (IND) submission documents, IND Annual Reports, New Drug Application documents, and Investigator Brochures
• Copyedits assigned documents, applying correct grammar, punctuation, spelling, formatting, and style
• Performs data integrity review of assigned documents to ensure accuracy
• Manages quality control workflow with outside MW and QC vendors
• Supports maintenance of document standards, including templates, style guide, drug-specific libraries of standard content, editing checklists, and best practice guides
• Supports department leadership in development and maintenance of department SOPs
• Assists with management of review schedules across multiple projects
• Supports ClinicalTrials.gov postings
• Offers solutions and proactive measures to address document quality findings
• Manages reference library
• Supports internal review process (i.e., PleaseReview)
• Sets standard of excellence for self and others
• Perform other duties as assigned

Qualifications :

Physical demands and work environment :

What can Harmony offer you?

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