Scientific Writer, Integrated Research Management

The Opportunity:

We are seeking a Scientific Writer with strong nonclinical regulatory experience to support the authoring and integration of nonclinical content for U.S. and global regulatory submissions. This role focuses on developing and integrating nonclinical content beyond INDs and NDAs, including briefing documents, Investigator Brochures, responses to health authority questions, and other submission-related materials across the U.S., Europe, and Asia.

As a strategic scientific integrator, this individual will translate complex RAS biology and translational pharmacology into clear, compelling regulatory narratives that reflect RevMed’s deep mechanistic understanding of RAS signaling and frontier targets. The role partners closely with nonclinical subject matter experts (SMEs) in pharmacology, toxicology, and DMPK, as well as Regulatory Affairs, Regulatory Operations, and Medical Writers, to ensure nonclinical strategy and content are scientifically rigorous, aligned, and submission-ready.

The Scientific Writer will leverage structured source documents, document management systems, and emerging AI-enabled tools to improve efficiency, consistency, and scalability of nonclinical regulatory writing. This role requires strong organizational skills and the ability to manage multiple programs and cross-functional inputs simultaneously in a fast-paced, scientifically rigorous environment.

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.

Preferred Skills:

• Industry experience as a Scientific or Medical Writer.

• Experience supporting global regulatory submissions (FDA, EMA, etc.).

• Proficiency with Veeva or similar Regulatory information management systems platforms.

• Experience leveraging AI-enabled tools for scientific or regulatory writing.

• Comfortable operating in a dynamic, evolving research and development environment. #LI-Hybrid  #LI-LN1