A top 10 Bio Pharma is looking for a Principal Medical Writer to join their talented team working in the Oncology and Immunology space. Working on the timely completion/delivery of information and review of clinical regulatory submissions, this position requires minimal oversight responsibilities. This is a fully-remote position allowing you to conduct all the work from your home!
• Provide clinical and regulatory document support and advanced writing expertise ensuring high quality submission ready documents
• Serves as medical writing lead on complex clinical regulatory documents such as filings and dossiers. Works closely with Regulatory on document strategies
• Converts relevant data and information into a form that meets clinical regulatory document requirements
• Ensures all clinical regulatory electronic document deliverables are processed and compiled in alignment with timelines
• BA/BS with scientific focus, advanced degrees preferred
• Experience with Investigative Brochure, Informed Consent Documents, Patient Inform Leaflets, Clinical Overview/Summaries, and Safety Narratives
• 4+ years of clinical and regulatory writing experience within the pharma/biotech industry
• 2+ years of industry experience preferred
• Exceptional written and communication skills
Please contact Paige Pecora on +1646.569.9081 or email email@example.com if you would like to know more about this opportunity. This will be 100% confidential.