Clinical & Regulatory Medical Writer

Viking Therapeutics, Inc.; San Diego (CA); On-site; USD 100,000 - 125,000; Full time

Job summary

Viking Therapeutics, Inc. is seeking a Medical Writer to plan, author, edit, and finalize clinical and regulatory documents across our GLP-1/GIP programs.

You will collaborate with Clinical Development, Biostatistics, Regulatory Affairs, and external CROs to produce study protocols, CSRs, IBs, and submission-related sections. The role requires 4+ years in regulatory/clinical medical writing, a life sciences degree, and strong writing skills.

Qualifications

• Bachelor’s degree in life sciences, pharmacy, or a related scientific discipline with 4+ years of regulatory/clinical medical writing experience
• Advanced degree (M.S., Pharm.D., or Ph.D.) with correspondingly relevant experience
• Experience authoring clinical-regulatory documents (e.g., protocols, CSRs, IBs, or clinical submission sections) within a GCP environment

Responsibilities

• Author, review, edit, and finalize clinical and regulatory documents – including clinical study protocols and amendments, clinical study reports (CSRs), investigator brochures (IBs), informed consent forms (ICFs), and the clinical sections of regulatory submissions (INDs, CTAs, NDAs) – in accordance with ICH-GCP, applicable regulatory guidance, and Viking standard operating procedures.
• Review safety and periodic reports and clinical narratives, and support timely, accurate responses to health authority questions in collaboration with Regulatory Affairs and Pharmacovigilance.
• Develop briefing documents and regulatory meeting materials (e.g., pre-IND, End-of-Phase 2, and advisory committee or scientific advice packages).
• Establish and manage document timelines, coordinate cross-functional reviews, and lead comment resolution and document finalization to meet submission deadlines.
• Ensure scientific accuracy, consistency, and adherence to style guides, templates, and document standards across the clinical document set.
• Manage medical writing deliverables outsourced to external CROs, contract medical writers, and vendors; provide direction, review, and quality oversight of outsourced documents.
• Maintain compliance with ICH-GCP, applicable FDA and EMA regulations, and data integrity (ALCOA+) and good documentation practices; support version control and archival within the electronic document management system.
• Contribute to the development and continuous improvement of medical writing templates, style guides, and standard processes.
• Other duties as assigned.

Skills

Medical writing

ICH-GCP

Regulatory submissions

Cross-functional collaboration

Education

Bachelor’s degree in life sciences or related field

Advanced degree (M.S., Pharm.D., or Ph.D.)

Tools

Microsoft Word

Document management systems

Job description

Viking Therapeutics, Inc. is seeking a Medical Writer to plan, author, edit, and finalize clinical and regulatory documents across our GLP-1/GIP programs.

You will collaborate with Clinical Development, Biostatistics, Regulatory Affairs, and external CROs to produce study protocols, CSRs, IBs, and submission-related sections. The role requires 4+ years in regulatory/clinical medical writing, a life sciences degree, and strong writing skills.