Remote Regulatory Writer

Start: 9/25

Interview: Phone, Skype

Length: 1 year plus

Type: Contract

Prerequisites:

• Minimum of BS/BA degree in science (Masters or PhD preferred) with at least 5 years of regulatory writing and submission experience
• Recent experience writing regulatory submission documents, eg, CSRs, CTD summaries or clinical overview, briefing books
• Experience in oncology, hematology, and/or inflammation and immunology therapeutic areas preferred
• Ability to work with complex projects, within cross-functional teams, and under tight timelines
• Requires attention to accuracy, quality, and adherence to format and stylistic requirements
• Excellent grammatical and communication skills, both written and oral
• Expertise in MS WORD

Responsibilities will include, but are not limited to, the following:

• Author regulatory submission documents, eg, CSRs, CTD summary documents (2.7.3, 2.7.4, possibly 2.7.1, and 2.7.2), and Clinical Overviews (2.5), Integrated Summaries of Efficacy and Safety, Pediatric Investigation Plans, Proposed Pediatric Study Requests, Requests of Product Specific Waivers, and applications for Orphan Drug Designations
• Prepare IBs (FIH/other, IB updates)
• Provide direction to team on content and optimal data presentation/summarization in the document
• Develop the strategy for document preparation and the document review processes, including the management of timelines
• Facilitate document review meetings and discussions
• May act as medical writing lead on submissions or new programs, including early development programs
• May contribute to Clinical Trial Data Sharing activities, including act as the lead for team review and redaction of private patient and/or confidential commercial information from documents and/or review documents prepared for redaction
• Complete required training on time