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: ASAPLocation: Remote, United StatesContract Type: W2, 30-40 hours per week, 12 Months ContractLanguage: EnglishProject: 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.