Medical Writer

Contract Medical Writer (CR/611583) New York, USA

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:

• Location:
  
  Remote, United States (East Coast preferred)
• Project:
  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.