Senior Specialist, Nonclinical Medical Writing

Medical Writer

We are seeking an experienced Medical Writer to join our Nonclinical Pharmacology Documentation group responsible for the generation of preclinical reports and submission modules to support development programs ranging from FIH to global marketing applications. This individual will partner with various research and regulatory functions to prepare high-quality scientific and regulatory documents that enable the advancement of therapeutic candidates across multiple disease areas and modalities. The successful candidate will independently manage multiple programs and document deliverables in parallel, effectively prioritize competing timelines, and drive project completion in alignment with key business objectives and regulatory milestones.

Key Responsibilities:

• Serve as a central coordinator for generating preclinical reports and regulatory submission modules, manage the overall scope and timeline, and guide the internal review/approval and submission processes, in collaboration with various research and regulatory functions.
• Conduct extensive preclinical data collection and QC to ensure the integrity of data assembly in compliance with regulatory requirements
• Analyze and synthesize nonclinical datasets, develop scientific narratives that integrate pharmacology, efficacy, and translational findings, and ensure consistency across documents.
• Author, edit, format, and submit pharmacology study reports, integrated pharmacology summaries, and other regulatory documents to internal documentation and filing system.
• Ensure all documents meet scientific, regulatory, and company quality standards, and maintain compliance with regulatory guidance and internal document management practices.
• Contribute to the development of writing templates, best practices, guidelines, and standards.
• Participate in the evaluation and adoption of new digital and AI tools to improve efficiency, quality, and scalability of scientific writing and document preparation.
• Support document QC and transfer related to business development & licensing activities, in collaboration with internal and external partners

Qualifications:

Education:

• Bachelor's (with 7+ years), Master's (with 4+ years) or Ph.D. (with 1+ year) in biology, pharmacology or related scientific disciplines with relevant experience in medical writing and regulatory submission in a pharmaceutical or biotech setting.

Required Experience and Skills:

• Familiar with the content of regulatory filings for nonclinical modules in the context of CTD, IND, CTA, IMPD, NDA/BLA/MAA.
• Excellent scientific writing and editing skills for generating high quality study reports, IB, CTD components (Module 2 Nonclinical summaries), as well as scientific manuscripts or documents.
• Solid understanding of the drug discovery and development processes, pharmacology principles, as well as standard laboratory operation for in vitro and in vivo data generation/collection.
• Hands on experience supporting nonclinical drug discovery and early development programs.
• Strong project management and organizational skills, with demonstrated ability to work with different stakeholders and balance competing priorities and evolving timelines in a fast-paced environment.
• Strong computer skills, proficiency with Microsoft Office, data graphing and visualization tools, and document management software.
• Strategic thinking and analytical skills, clear written and verbal communication.
• Excellent attention to details and commitment to quality.

Preferred Experience and Skills:

• Familiarity with therapeutic areas such as oncology, neuroscience, immunology, cardiovascular-metabolic, or infectious diseases.
• Working knowledge of different therapeutic modalities (small molecules, biologics, drug conjugates, etc.) and/or vaccine development.
• Experience with AI-enabled data retrieval, QC, and scientific writing tools.
• American Medical Writers Association certificate.

Required Skills:

Detail-Oriented, Drug Discovery Process, Medical Writing, Pharmacology, Regulatory Compliance, Regulatory Documents, Regulatory Filings, Regulatory Processes, Regulatory Research, Regulatory Submissions, Scientific Literacy, Scientific Writing, Study Reports, Technical Communication

Preferred Skills:

Salary range for this role is $131,400.00 - $206,800.00