Senior Medical Writer

Scorpion Therapeutics; Indiana (PA); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Clinical writing experience

Neurotherapeutics focus

Global submissions

Veeva Vault familiarity

Job summary

Centessa Pharmaceuticals is seeking a Senior Medical Writer to support clinical regulatory documentation for its neurodevelopmental asset portfolio, including orexin receptor agonists for narcolepsy and sleep disorders. You will author and manage key documents and collaborate across Clinical Development, Regulatory Affairs, Biostatistics, and other teams.

The role requires a PhD or advanced degree and 4+ years of pharmaceutical medical writing experience, with preference for neuroscience

Qualifications

• PhD or advanced degree in a scientific or clinical discipline.
• 4+ years in pharmaceutical medical writing with at least 2 years in sponsor-level roles.
• Neuroscience experience preferred.
• Strong regulatory knowledge, including global trial submission requirements (FDA, EMA, PMDA).

Responsibilities

• Author and manage clinical study documents (protocols, Investigator Brochures, Clinical Study Reports).
• Collaborate with Clinical Development, Regulatory Affairs, Biostatistics, and other teams.
• Oversee document lifecycle from draft to review and finalization, ensuring compliance with GCP, ICH, eCTD, and company standards.
• Interpret complex clinical data and contribute to SOP development.

Skills

Regulatory writing

Clinical documentation

SOP development

Cross-functional collaboration

Education

PhD or equivalent

Job description

Senior Medical Writer

Supporting clinical regulatory documentation for Centessa Pharmaceuticals' neurodevelopmental asset portfolio, including orexin receptor agonists for narcolepsy and sleep disorders.

Responsibilities

• Author and manage clinical study documents (protocols, Investigator Brochures, Clinical Study Reports)
• Collaborate with Clinical Development, Regulatory Affairs, Biostatistics, and other teams
• Oversee document lifecycle from draft to review and finalization, ensuring compliance with GCP, ICH, eCTD, and company standards
• Interpret complex clinical data and contribute to SOP development

Requirements

• PhD or advanced degree in a scientific or clinical discipline
• 4+ years in pharmaceutical medical writing with at least 2 years in sponsor-level roles
• Neuroscience experience preferred
• Strong organizational, communication, and regulatory knowledge, including global trial submission requirements (FDA, EMA, PMDA)

High-Value

• Clinical/regulatory writing
• Neurotherapeutics
• Sleep disorder indications
• Development stage (clinical)
• GCP/ICH compliance
• Cross-functional collaboration
• Familiarity with document management platforms (e.g., Veeva Vault)

WorkSetup: not specified.