Job Description

Responsibilities:

• Clinical / medical writing experience – pref. in oncology
• Experience at bringing together submission content (Mod 2.5, 2.7 etc)
• Experience at working with internal clinical SMEs, pulling together their content into briefing documents / submission content
• Prior knowledge of Pfizer systems is desirable but not mandatory East coast based preferably
• Write, edit, and format various regulatory documents, publications, and presentation materials for NDA submission
• Coordinate document review cycles, incorporate comments, and collect signatures for finalization
• Develop and maintain timelines for document/publication review and finalization
• Assist in the development of in-house medical writing materials for NDA submission (such as SOPs and style guide)
• Provide quality control (QC) review of various regulatory documents
• Collaborate with others and effectively represent Medical Writing/ Clinical Regulatory on inter-departmental project teams

Qualifications

• A minimum of a BS degree and 3+ years’ experience in a pharmaceutical, biotech or CRO environment
• Demonstrated solid knowledge and Experience in Medical Writing and/ or Clinical Regulatory (IND, NDA, briefing books, DSUR, Literature Writing etc.)
• Recent experience with an NDA submission desired
• Experience writing and managing clinical regulatory documents
• Knowledge of science and clinical research concepts
• The ability to understand and summarize clinical data
• Writing ability for different types of clinical and regulatory documents
• Knowledge of FDA and ICH guidelines
• Demonstrated solid project management skills
• Proven experience in working in a high volume environment handling multiple tasks
• Excellent time and priority management, able to work efficiently under pressure
• Works accurately and to detail
• Strong organizational skills
• Strong computer skills, including Word, PowerPoint, and Excel
• Excellent grammatical and communication skills, both written and oral
• Expertise with electronic publishing desired
• Proven ability to interact seamlessly and collaboratively with client in a consulting relationship