Medical Writer - Clinical Regulatory Documentation

Perspective Therapeutics • United States,

22d

About The Position

Reporting to the Head of Medical/Regulatory Writing, the Medical Writer – Clinical Regulatory Documentation will be responsible for the preparation and delivery of high-quality, scientifically accurate, and regulatory-compliant clinical/medical documentation to support clinical development and regulatory submissions. This role will collaborate with cross-functional teams to author clinical/regulatory documents, including protocols, clinical study reports (CSRs), investigator brochures (IBs), and clinical modules for INDs/CTAs, NDAs/MAAs, and other regulatory documents.

Requirements

• Applicants that have worked directly for a sponsor or CRO.
• Experience of 5-8 years in medical writing within the pharmaceutical, biotechnology, or clinical research industry.
• Experience in oncology therapeutic area is highly preferred.
• Familiarity with global regulatory requirements for clinical documentation (e.g., FDA, EMA, ICH).
• Strong understanding of clinical trial processes and regulatory submissions, including preparation of clinical protocols, CSRs, investigator brochures (IBs), and clinical modules for INDs, NDAs/MAAs.
• Ability to manage multiple writing projects simultaneously and meet deadlines while maintaining high-quality standards.
• A minimum of a Bachelor’s degree in a life sciences discipline (e.g., Pharmacology, Pharmaceutical Sciences, Biology, or related field).
• At least 5-8 years of experience in medical writing, with hands-on experience in authoring clinical documents for regulatory submissions.
• Experience in oncology therapeutic area is highly preferred.
• Experience with writing for regulatory submissions (INDs, NDAs/BLAs/MAAs) is highly preferred.
• Excellent written and verbal communication skills with the ability to convey complex scientific information clearly and concisely for a variety of audiences.
• Experienced with standardized writing templates (e.g. StartingPoint or alike) and regulatory submission management platforms (e.g. Veeva Vault).
• Strong understanding of global regulatory requirements for clinical trials and medical documentation (e.g., FDA, EMA, ICH).
• Exceptional attention to detail and a commitment to producing accurate, high-quality documents.
• Ability to collaborate effectively with cross-functional teams, including clinical, regulatory, and other departments, to produce high-quality documentation.
• In-depth understanding of clinical research and scientific concepts to ensure that clinical documents are scientifically accurate and reflect the latest research findings.
• Strong organizational and time management skills, with the ability to manage multiple projects and meet deadlines in a fast-paced environment.
• Ability to proactively identify and address challenges related to document quality, clarity, and regulatory requirements.

Nice To Haves

• A Master’s or Ph.D. is preferred.

Responsibilities

• Author clear, concise, and scientifically accurate clinical documents, including but not limited to clinical protocols, clinical study reports (CSRs), investigator brochures (IBs), clinical trial documents, and Modules for regulatory submissions (INDs, NDAs/MAAs, etc.).
• Work closely with clinical development, regulatory affairs, and other stakeholders (e.g., nonclinical, CMC etc) to ensure that all medical writing deliverables meet project objectives, timelines, and regulatory requirements.
• Ensure all documents are in compliance with applicable global regulatory requirements (e.g., FDA, EMA, ICH guidelines) and adhere to internal standards and best practices.
• Participate in the review and revision of clinical documents based on feedback from internal stakeholders and external regulatory bodies. Ensure that documents are well-organized, accurate, and aligned with regulatory expectations.
• Assist in maintaining high-quality standards for all clinical documentation. Ensure consistency, accuracy, and scientific rigor in all written materials.
• Provide medical writing support across various stages of clinical development, including early-phase studies, late-stage clinical trials, and regulatory submissions. Manage the preparation of documents within established timelines.
• Stay current with relevant scientific literature, regulatory guidelines, and industry trends to inform writing and ensure documents reflect the latest standards and best practices.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior