Location: (100% Remote Role)
Pay Rate: Open
Contract: 6 Months w/ Possible Extension
Job Description
The Technical Writer is responsible for converting scientific data into clear, scientifically sound, well-structured scientific, technical and regulatory documents intended for global health authorities and internal/external stakeholders. The job scope is focused on authoring and managing the review and approval of moderate to complex CMC regulatory documents, including but not limited to Module 2 and Module 3 CMC regulatory submissions for development and post-approval dossiers, technical reports and SOPs.
Knowledge/Skills/Abilities:
* A background of pharmaceutical manufacturing or quality control/quality assurance is a plus. A working knowledge of cGMP's is desired.
* Superior working knowledge of software programs in Windows environment with excellent proficiency in word processing, flow diagrams, and spreadsheets.
* Ability to learn fast, grasp the "essence" of a strategy or a story quickly to convert relevant scientific data/information into high quality summaries and reports.
* Excellent organizational, writing, communication and time management skills needed to manage multiple ongoing projects and/or other writers simultaneously.
* Well-developed analytical skills and strong knowledge of technical terminology.