Medical Writer, CNS, Biologics, Vaccines

This is a fully remote position, open to applicants in New Jersey.

📋 Description

• Draft clinical and regulatory documents for CNS development initiatives within a global biopharmaceutical firm's Biologics Business Unit.

• Compose and refine documents to satisfy regulatory standards (ICH, GCP) and internal company guidelines.

• Develop clinical study protocols and their amendments.

• Create Investigator's Brochures (IBs).

• Generate Clinical Study Reports (CSRs).

• Prepare briefing materials for meetings with health authorities.

• Compile IND and NDA summary documents along with other submission materials.

• Collaborate with teams from Clinical Development, Clinical Operations, Biostatistics, Data Management, Regulatory, Pharmacovigilance, and Medical Affairs.

• Facilitate review cycles, address reviewer feedback, and foster consensus among stakeholders.

• Negotiate timelines for documents and ensure that deliverables are on track.

• Assist in enhancing writing processes, templates, and style guides.

⛳️ Requirements

• Over 5 years of experience in regulatory medical writing within pharma, biotech, or a CRO, serving as a hands-on writer.

• Recent experience in CNS (neurology or psychiatry) is required.

• Experience in writing for biologics or vaccines.

• Proven ability to author protocols, CSRs, IBs, and submission documents.

• Strong understanding of ICH guidelines and the clinical development process.

• Must be available during U.S. East Coast hours, including occasional meetings at 8 AM ET and between 6–8 PM ET with teams based in Japan.

• A Bachelor's degree or higher is required, with an advanced degree preferred.

• Candidates with an oncology-exclusive background will not be considered.

• Medical communications or marketing writers without experience in regulatory documents should not apply.

🏝️ Benefits

• Work hours start at 20–40 per week, with opportunities to increase hours and take on more responsibilities.