about 1 month ago
This work can be done remotely or from any of our US-based offices.
Essential Functions of the Job:
- Leads, plans, authors, and coordinates regulatory writing deliverables through direct support as a strategic communications expert or through oversight of internal or vendor staff across a program.
- Provides support and/or coordinates QC of regulatory documents.
- Works effectively with cross-functional groups to ensure the production of high-quality, scientifically accurate documents under aggressive timelines, and ensures consistency and alignment between related documents.
- Drives continuous improvement by implementing best practices in communication and submission preparation.
- Provides strong partnerships with vendor medical writers to ensure delivery to time, cost, and quality.
- Trains less experienced Regulatory Writers.
Knowledge and Skills
- At least 5-8 years of relevant industry experience in a pharmaceutical, biotech or vendor writing position is required. Previous managerial experience is preferred.
- Demonstrated ability to communicate and write scientific and regulatory documents clearly, concisely, and effectively.
- Experience in writing the following documents, including but not limited to: briefing documents, IND/CTAs, submissions for marketing applications through approval (eg, BLAs, NDAs, MAAs) including regulatory defense, pediatric study plans, and special applications (eg, Orphan Drug Designation, Breakthrough Therapy Designation).
- Well-organized: ability to prioritize tasks, work simultaneously on multiple projects, and ensure the completion of high-quality documents according to tight timelines and shifting priorities/demands.
- Excellent interpersonal skills - must have an ability to work well with others in high-pressure situations, a team player.
- Strong project management and leadership skills.
- The technical/scientific ability to critically analyze, synthesize, and present complex information in well-constructed documents
- Working knowledge of drug/biologics development, clinical research, study design, biostatistics, and regulatory guidelines/guidance (eg, FDA, EMEA and ICH guidelines for various scientific documents) is required.
- Experience in working with global teams and creating global documents that meet the requirements of more than one region.
Education Required: At a minimum, a BA/BS degree; Master’s/PhD/PharmD in life sciences preferred.
- Will provide oversight of vendor writers as needed.
Computer Skills: Technical expertise in the Microsoft Office Suite (ie, Word, Excel, Outlook, PowerPoint, OneNote), Adobe Acrobat, and document management systems. Experience with Veeva Vault, SharePoint and SmartSheet is preferred. Experience and skill performing literature searches.
Travel for Work: On occasion as needed. #LI- AM2