Scientific Writer (Madison)
TSR Consulting, Madison, NJ, United States
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.
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.