Director, Pharmaceutical Writing Services 

Job Type: Full-Time, Remote, W-2 Employee 

At Criterion Edge, we’re committed to empowering companies to deliver better healthcare solutions. By leveraging best-in-class writing processes, technology, and expertise, we empower healthcare companies to achieve their global regulatory goals with superior quality, speed, and budget control. Be on the leading edge by applying your regulatory writing expertise and leadership skills to the development, management and writing of regulatory-compliant pharmaceutical projects with top industry clients. 

Criterion Edge (CE) is seeking a remote candidate for the role of Director, Pharmaceutical Writing Services. The position is responsible for providing management oversight and regulatory/scientific writing expertise to support and lead multiple writing projects that support our client’s portfolio of pharmaceutical products. Please note that significant pharmaceutical writing experience, client interaction experience and management of scientific writers is required for this role. 

***In this client-facing role, you will work collaboratively with team members to strategize, edit, and review documents such as clinical study reports (CSRs), subject narratives, investigative brochures (IBs), clinical sections of INDs, NDAs and BLAs, protocols, and/or briefing documents. In addition to writing, reviewing and editing documents on complex writing projects, you will be asked to mentor more junior writers on your writing teams.*** 

Specific responsibilities include: 

• Independently author and review a broad range of clinical, scientific, and regulatory submission documents within a team environment, including, but are not limited to, CSRs, subject narratives, clinical sections of INDs, NDAs and BLAs, protocols, and/or briefing documents.  

• Provide consistent, expert scientific oversight on all assigned projects. 

• Collaborate with the Project Management team to assign appropriate writing resources to each project.  

• Contribute to the development of client timelines; contribute to and facilitate internal and client meetings.  

• Oversee initial scoping of new projects and attend project kick-off meetings.   

• Mentor Principal Writers and other writers that are assigned to the writing project.  Assist writers with project related questions as needed. 

• Review regulatory documents and responses to regulatory authorities as needed, 

• Perform internal document reviews, editing, and QC as needed, and provide feedback to project team.. 

• Develop internal training resources and materials as needed and conduct training as needed 

• Provide input into company process development and improvement. 

• Ensure documents are produced in accordance with procedures, internal and external guidelines, and electronic templates. 

• Coach and mentor all project-related activities to ensure alignment with applicable regulatory requirements and Criterion Edge quality standards.  

• Review /oversee the systematic literature review process when needed 

Required Experience: 

• Training and advanced degree in science, engineering, or medical fields. Scientific/research background required, with a deep understanding of research design, methodology, and statistics  

• CRO/Pharma/Biotech industry knowledge; current best practices and versed in current regulations for medical and scientific documents, drug development cycles, and regulatory standards. 

• Experience with independently authoring CSRs, Protocols and regulatory submission documents, such as IND, NDA and/or BLA components (integrated summaries and clinical summaries). 

• Strong analytical skills; ability to understand and interpret complex clinical and scientific data. Formulate those data in a well-thought out and reviewer‑friendly manner. Clear written communication skills; ability to present written results in an understandable manner to a variety of audiences. 

• Effective written, verbal and presentation skills around technical/clinical applications 

• Strong command of medical and surgical terminology 

• Demonstrated ability to identify and adapt to shifting priorities and competing demands 

• Proven leadership in the management of teams 

• Highly skilled in document development and management using Sharepoint, Distiller, Word, Excel, PowerPoint and EndNote