Director, Medical Writing - Remote Strategy Lead

EPM Scientific; United States; A distancia; USD 150.000 - 230.000; Jornada completa

Descripción de la vacante

EPM Scientific is partnering with a clinical-stage biotechnology company to recruit a Director of Medical Writing. This role supports the Clinical Development and Regulatory Affairs team from a remote position in the United States.

Key responsibilities include leading authoring of protocols, CSRs, and IBs, coordinating cross-functional inputs, and guiding regulatory submission planning and execution. Strong leadership and advanced degrees are favored.

Formación

• Bachelor’s degree in life sciences; advanced scientific degree preferred.
• Extensive medical writing experience in pharma/biotech with leadership in clinical/regulatory docs.
• Strong understanding of drug development, clinical research, and global regulatory requirements.
• Experience authoring protocols, CSRs, IBs and submission-related deliverables.
• Proven ability to lead cross-functional teams and manage multiple stakeholders.

Responsabilidades

• Lead planning, coordination, and authoring of clinical and regulatory documents (protocols, CSRs, IBs).
• Partner with cross-functional stakeholders to ensure accuracy and consistency.
• Provide strategic medical writing expertise for regulatory submission planning and execution.
• Ensure deliverables comply with ICH, regulations, internal standards, quality expectations.
• Represent Medical Writing in meetings, reviews, and project discussions; mentor junior writers.
• Oversee timelines, review cycles, and manage external writing resources.

Conocimientos

Leadership

Cross-functional collaboration

Mentoring

Project management

Scientific writing

Educación

Bachelor's degree in life sciences

MSc/PhD preferred

Descripción del empleo

EPM Scientific is partnering with a clinical-stage biotechnology company to recruit a Director of Medical Writing. This role supports the Clinical Development and Regulatory Affairs team from a remote position in the United States.

Key responsibilities include leading authoring of protocols, CSRs, and IBs, coordinating cross-functional inputs, and guiding regulatory submission planning and execution. Strong leadership and advanced degrees are favored.