Director Medical Writing

EPM Scientific; United States; Remote; USD 150,000 - 230,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Leadership

Cross-functional collaboration

Mentoring

Project management

Scientific writing

Education

Bachelor's degree in life sciences

MSc/PhD preferred

Job description

Director Medical Writing (CR/611583) New York, USA

EPM Scientific are currently partnered with a clinical-stage biotechnology company focused on innovative therapies for immune-mediated diseases. They are urgently seeking a Director, Medical Writingto support their expanding Clinical Development and Regulatory Affairs team. See a summary of the role below:

Role Overview:

• Location: Remote, United States
• Contract Type: W2, 30-40 hours per week, 12 Months Contract
• Project: Clinical Development & Regulatory Medical Writing

Key Responsibilities:

• Lead the planning, coordination, and authoring of clinical and regulatory documents, including protocols, clinical study reports (CSRs), investigator brochures (IBs), and related submission materials.
• Partner with cross-functional stakeholders to ensure scientific accuracy, consistency of messaging, and alignment across development and regulatory documentation.
• Provide strategic medical writing expertise to study teams and contribute to regulatory submission planning and execution.
• Ensure all deliverables comply with ICH guidelines, regulatory requirements, internal standards, and document quality expectations.
• Represent Medical Writing in cross-functional meetings, document reviews, and project discussions while acting as a key point of contact for writing deliverables.
• Oversee timelines, review cycles, and document development activities while mentoring junior writers and supporting external writing resources where required.

Requirements:

• Bachelor’s degree in a life sciences discipline required; advanced scientific degree (MSc, PharmD, PhD, or equivalent) strongly preferred.
• Extensive medical writing experience within the pharmaceutical or biotechnology industry, including leadership responsibility for clinical and regulatory documentation.
• Strong understanding of the drug development process, clinical research methodology, and global regulatory requirements.
• Demonstrated experience authoring and leading key regulatory documents such as protocols, CSRs, investigator brochures, and submission-related deliverables.
• Experience working within cross-functional clinical development teams and managing multiple stakeholders in a fast-paced environment.
• Excellent communication, project management, leadership, and mentoring skills with the ability to work independently in a remote setting.