Director Medical Writing

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 Writing to support their expanding Clinical Development and Regulatory Affairs team. See a summary of the role below:

Role Overview:

• Start date: ASAP
• Location: Remote, United States
• Contract Type: W2, 30-40 hours per week, 12 Months Contract
• Language: English
• 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.

If this role is of interest to you, please apply directly to learn more. If not, feel free to share with your network.