Contract Medical Writer

EPM Scientific are currently partnered with a US-based Biotechnology company focused on advancing innovative therapies across multiple clinical development programs. They are urgently seeking a Contract Medical Writer, reporting to the Medical Writing Leadership team, to support their expanding Clinical Development function. This individual will play a key role in authoring and coordinating critical clinical regulatory documents while collaborating cross-functionally in a fast-paced, growing environment. See a summary of the role below: Role Overview:Start date: ASAPLocation: Remote, United States (East Coast preferred)Contract: W2, 12 Month Contract, 30-40 hours per week, flexible depending on candidate availabilityLanguage: EnglishProject: Clinical Regulatory & Development Documentation Key Responsibilities:Lead the development, authoring, and review of key clinical documents including study protocols, protocol amendments, and Clinical Study Reports (CSRs).Act as the lead medical writer for assigned studies, driving document strategy, timelines, and cross-functional alignment.Partner closely with Clinical Operations, Clinical Development, Biostatistics, Data Management, and other study team members to ensure high-quality deliverables.Support document quality control activities, including peer review and QC of medical writing deliverables.Contribute to responses for regulatory authority questions, requests for information (RFIs), and other submission-related activities.Provide guidance to study teams throughout the document development process, ensuring consistency, scientific accuracy, and compliance with regulatory expectations.Manage multiple priorities within a dynamic, fast-paced biotechnology environment while maintaining delivery timelines. Requirements:Bachelor's, Master's, PharmD, or PhD in a life sciences or related discipline.Strong medical writing experience within the pharmaceutical, biotechnology, or CRO industry.Demonstrated experience authoring clinical study protocols, protocol amendments, and Clinical Study Reports (CSRs).Ability to independently lead document development activities and work effectively with cross-functional study teams.Experience supporting regulatory submissions and responding to health authority questions is highly desirable.Previous experience in small biotech or start-up environments preferred, with the ability to adapt quickly to changing priorities.Excellent written and verbal communication skills, strong attention to detail, and a proactive, collaborative approach. If this role is of interest to you, please apply directly to learn more. If not, feel free to share with your network.