Scientific Writer

Job Title: Nonclinical Regulatory Document and Scientific Writer

Duration: 12 Months Contract

Location: Madison, NJ 07940 (Hybrid – 50% onsite)

Schedule: Monday–Friday | 8:00 AM – 5:00 PM

Pay Rate: $67.98/hr (W2)

Role Summary

Reporting to the Program Management Lead, this role supports the Late Development Translational team by developing high-quality scientific and regulatory documents. The Scientific Writer will partner closely with Translational scientists to produce biomarker reports, regulatory submission content, and scientific communications supporting late-stage drug development programs.

Key Responsibilities

• Author and deliver scientific and regulatory documents including biomarker reports, non-clinical summaries, translational sections of clinical/pharmacology summaries, briefing books, CSRs, and investigator brochures.
• Contribute to abstracts, posters, manuscripts, and scientific communications.
• Support regulatory submissions and responses, including IND/NDA documentation and regulatory queries.
• Develop and manage publication strategies, timelines, and annual publication plans in collaboration with Translational Development teams.
• Partner cross-functionally with Clinical, Non-Clinical Development, Pharmacology, DMPK, Regulatory, Medical Affairs, and Scientific Communications teams.
• Analyze and synthesize complex scientific data into clear narratives, tables, and visual presentations.
• Ensure compliance with writing SOPs, documentation systems (e.g., CARA, VERITY), and company standards.
• Present updates and communicate progress across internal and external stakeholders.

Required Expertise

• Strong knowledge of hematological malignancies, solid tumors, or neuroscience disorders, including clinical landscape and emerging therapies.
• Deep understanding of clinical, translational, and mechanistic data for late-stage development programs.
• Experience preparing regulatory documents and scientific communications.
• Familiarity with documentation systems such as CARA, VERITY.
• Understanding of global development processes and lifecycle management across US, EU, and Canada.
• Ability to translate complex scientific data into clear, strategic messaging.
• Working knowledge of IP and contracting concepts.

Qualifications

• Master’s or PhD in Hematology, Oncology, Neuroscience, or related field.
• 6–8 years of industry or academic experience in scientific/medical writing.
• Experience supporting regulatory submissions (IND, NDA/sNDA).
• Strong communication, project management, and collaboration skills.
• Proven ability to manage multiple priorities in a fast-paced environment.

Additional Attributes

• Highly organized, detail-oriented, and proactive problem solver.
• Strong cross-functional collaboration and leadership skills.
• Ability to anticipate risks and propose solutions.
• Passion for advancing therapies that improve patient outcomes.