Scientific Writer, Integrated Research Management

Key Responsibilities

• Author, integrate, and edit nonclinical sections of regulatory documents across multiple submission types, including INDs, NDAs, briefing documents, amendments, and response to health authority requests.
• Safeguard and articulate the scientific rationale underlying RevMed’s RAS(ON) and companion inhibitor programs across regulatory communications.
• Develop clear, hypothesis-driven regulatory narratives that integrate pharmacology, toxicology, and DMPK data, and engage as a critical scientific thought partner to these functions to strengthen mechanistic coherence, regulatory positioning, and alignment with global regulatory expectations (FDA, EMA, and select Asian agencies).
• Collaborate closely with project Medical Writers to ensure nonclinical sections are delivered in alignment with overall timelines and coordinated with related document sections.
• Ensure scientific consistency across programs to preserve and extend RevMed’s reputation for rigor and mechanistic depth.
• Manage multiple regulatory writing efforts in parallel, balancing priorities across programs and functions in a fast-paced environment.
• Utilize Regulatory information management systems (e.g., Veeva) and AI-enabled writing tools to support authoring, review, and lifecycle management of regulatory documents.
• Contribute to templates, guidance, and best practices for global nonclinical regulatory documentation.
• Drive continuous improvement of nonclinical authoring standards, templates, and knowledge management systems.
• Capture and institutionalize lessons learned from prior submissions to improve quality, consistency, and efficiency across programs and regions.

Required Skills, Experience and Education

• Advanced degree (PhD preferred; MS considered) in a relevant nonclinical scientific discipline.
• Demonstrated experience authoring or substantially contributing to nonclinical sections of regulatory submissions across multiple document types.
• Strong working knowledge of pharmacology, toxicology, and DMPK and their integration into regulatory narratives.
• Demonstrated ability to synthesize complex mechanistic datasets into coherent, hypothesis-driven regulatory narratives.
• Comfortable engaging deeply in data discussions with subject matter experts and operating in a culture of scientific debate and rigorous review.
• Familiarity with range of regulatory expectations including those beyond the U.S. such as European and/or Asian health authorities.
• Proven ability to manage multiple projects concurrently and work effectively across functions.
• Excellent written communication skills, attention to detail, and a collaborative, solutions-oriented mindset.