Contract Medical Writer

EPM Scientific; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

EPM Scientific is recruiting a Contract Medical Writer in New York, USA to support a US biotech client. The role focuses on authoring and coordinating key clinical regulatory documents while collaborating with cross‑functional teams in a fast‑paced setting.

The ideal candidate has strong medical writing experience, can lead protocol and CSR development, and support regulatory submissions. This contract role requires excellent communication and attention to regulatory detail.

Qualifications

• Strong medical writing experience in pharma/biotech/CRO environments.
• Experience authoring study protocols, amendments and CSRs.
• Ability to lead document development with cross-functional teams.
• Experience supporting regulatory submissions and health authority responses.
• Adaptable to fast-paced biotech/start-up settings.

Responsibilities

• Lead development, authoring and review of clinical documents including protocols and CSRs.
• Act as lead medical writer for assigned studies, driving strategy and timelines.
• Collaborate with Clinical Operations, Biostatistics, Data Management and study teams.
• Support QA activities, peer review and QC of deliverables.
• Contribute to regulatory submissions and responses to information requests.
• Provide guidance to study teams to ensure accuracy and regulatory compliance.
• Manage multiple priorities in a dynamic biotech environment.

Skills

Medical writing

Clinical study protocols

CSRs

Regulatory submissions

Cross-functional collaboration

Education

Bachelor's degree in life sciences

Master’s degree in life sciences

PharmD/PhD preference

Job description

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.