Senior Medical Writer

This is a fully remote position, open to applicants in United States.

📋 Description

• Create and assist in the development of medical writing materials, which include clinical protocols and amendments, Investigator Brochures, clinical study reports, agency information requests, IND/CTA submission documents, NDA/MAA clinical modules, summary documents, and other necessary writings.

• Collaborate effectively with teams in Clinical Development, Regulatory Affairs, Biostatistics, Pharmacovigilance, CMC, and Project Management.

• Work alongside both internal and external writers to facilitate the completion of documents.

• Manage the document preparation process from initiation and planning through drafting, review cycles, feedback integration, revisions, quality control, quality assurance findings, and final submission within established timelines.

• Ensure that clinical documents across programs are clear, consistent, and properly formatted.

• Adhere to compliance standards set forth by GCP, ICH, eCTD, and company guidelines.

• Analyze and interpret complex clinical data and information.

• Exhibit strategic thinking and reviewing capabilities.

• Contribute to the development and enhancement of SOPs, templates, and document standards.

• Report directly to the Director of Medical Writing Operations.

⛳️ Requirements

• PhD or advanced degree in a scientific or clinical discipline.

• Over 4 years of experience in medical writing or relevant pharmaceutical industry roles, including a minimum of 2 years in sponsor-level clinical/regulatory medical writing.

• Previous experience in neuroscience is highly preferred.

• Excellent organizational, communication, and influencing abilities; adept at prioritizing, multitasking, and producing high-quality documents under tight deadlines.

• Ability to adapt to changing priorities and targets with flexibility.

• Comprehensive understanding of drug development, biostatistics, and medical terminology.

• Basic knowledge of scientific methodology as it relates to drug development.

• Familiarity with global clinical trials and regulatory submission requirements, including FDA, EMA, PMDA, ICH, GCP, CTD/eCTD, and EU privacy/redaction regulations.

• Proficiency in advanced features of Microsoft Word.

• Experience with document management and collaborative authoring tools such as Veeva Vault and Please Review.

• Capability to work both independently and collaboratively in a fast-paced, dynamic, cross-functional environment.

• Highly accurate, detail-oriented, and professional, with exceptional interpersonal skills and a calm, diplomatic approach to challenges.

🏝️ Benefits

• Company bonus based partially on both company and individual performance.

• Company-sponsored 401(k) plan.

• Pension benefits.

• Vacation benefits.

• Comprehensive medical, dental, vision, and prescription drug coverage.

• Flexible benefits options, including healthcare and/or dependent day care flexible spending accounts.

• Life insurance and death benefits.

• Various time off and leave of absence benefits.

• Well-being benefits, such as an employee assistance program, fitness benefits, and participation in employee clubs and activities.

• Employee resource groups that are open to all employees.