Medical Writer — Clinical Trials & Regulatory Submissions

SystImmune, Inc.; Princeton (NJ); Presencial; USD 80.000 - 130.000; Jornada completa

Descripción de la vacante

SystImmune, Inc. in Princeton, NJ is seeking a Medical Writer responsible for managing and overseeing clinical writing projects, including protocols, reports, INDs, and investigator brochures, ensuring high quality and regulatory compliance.

You will work within clinical trial teams to track milestones and produce strategic documents, with strong writing and communication skills, and knowledge of FDA/ICH guidelines.

Formación

• Master's degree in life sciences or 3–4 years pharma writing experience.
• Excellent writing and communication skills.
• Experience writing major documents (protocols, CSRs, ISE/ISS, Clinical Overview).
• Knowledge of FDA/ICH guidelines and regulatory submission processes.
• Ability to work in a matrix management environment.

Responsabilidades

• Write, edit and manage production of clinical documents (protocols, synopses, CSR) for regulatory submissions.
• Act as a member of clinical trial teams.
• Follow and track clinical documentation milestones.
• Write/edit other strategic documents as required.

Conocimientos

Excellent writing

Effective communication

Interpersonal skills

Organizational skills

Problem-solving

FDA/ICH guidelines knowledge

Clinical data interpretation

Regulatory document experience

Educación

Master's degree in life sciences

PhD in life sciences (with pharma writing experience)

Herramientas

Regulatory guidelines knowledge (FDA/ICH)

Descripción del empleo

SystImmune, Inc. in Princeton, NJ is seeking a Medical Writer responsible for managing and overseeing clinical writing projects, including protocols, reports, INDs, and investigator brochures, ensuring high quality and regulatory compliance.

You will work within clinical trial teams to track milestones and produce strategic documents, with strong writing and communication skills, and knowledge of FDA/ICH guidelines.