Director, Medical Writing

Harmony Biosciences is recruiting for a Director, Medical Writing in our Plymouth Meeting, PA location. In this role you will be accountable for the timely preparation of high-quality regulatory documents supporting the clinical development portfolio at Harmony. This includes, but is not limited to, authoring, editing, and providing project management support for clinical regulatory documents including protocols, amendments, investigator’s brochures, and clinical study reports, as well as various other clinical and non-clinical documents.

Responsibilities include but are not limited to :

• Lead and manage all aspects of the preparation of regulatory documents for submission to global regulatory authorities in accordance with ICH and other global guidelines, standards and processes, and AMA Medical Writing styles, as applicable, in adherence with study / project timelines and corporate objectives.
• Manage EU regulatory submissions in collaboration with appropriate external resources.
• Manage contract medical writing resources as required to ensure timely completion of assigned projects.
• Actively participate in study and / or project team meetings to provide input regarding medical writing deliverables, timelines, and any process(es) needed for the completion of regulatory documents.
• Develop and implement process standards.
• Review, edit, and ensure quality of documents prepared by other functional area representatives (such as Biostatistics and Clinical Operations) to ensure adherence to standards and global regulatory guidance and requirements.
• Write, review, and / or edit clinical trial registry postings.
• Manage transparency / disclosure vendors.
• Sets standard of excellence for self and others.
• Perform other duties as assigned.

Qualifications :

Physical demands and work environment :

What can Harmony offer you?