CAPR has 13 open positions including a Senior Tech Writer. They mention BLA twice!!
Position:
Senior Technical Writer (Ph.D.)
This position is immediately available
Duties:
• Development process may include writing interpreting and summarizing clinical and nonclinical data, and compiling information.
• This candidate must have strong experience with writing submissions. Documents may include
preclinical and clinical publications, federal and state grant submissions (NIH, DOD, etc),
CSRs, INDs, manuscripts, abstracts, posters, and presentations.
• Will participate in ensuring compliance of clinical documents with national and international
regulatory requirements and guidelines and procedures (as applicable). Includes collaborating
with medical editors to ensure documents are publication ready.
• Develop knowledge of all therapeutic areas.
• Experience in the analytical evaluation of scientific data
• Exceptional organizational skills and meticulous attention to detail
• Independently author a broad range of scientific documents, such as such as CSRs, subject
narratives, clinical sections of INDs, NDAs and BLAs, protocols and/or briefing documents
• Act as a project manager for complex writing projects and have responsibility for resource
coordination and utilization, timelines and review and oversight of deliverables
• Perform internal document reviews, editing and QC as needed
• May be asked to participate in business development efforts, including project proposals
• Works with the Nonclinical, Clinical, and Regulatory Affairs team members to prepare
documents under strict timelines; documents may include pre-clinical study protocols and
reports and clinical study protocols
• Provides leadership in planning and completing required documents for regulatory
submissions to US and global health authorities, including Investigational New Drug (IND)
applications and Biologics License Applications (BLAs)
