About This Role
This role is responsible for planning, authoring, editing, and finalizing high-quality clinical and regulatory documents for Viking Therapeutics' clinical development programs. Reporting to the Vice President, Clinical Development, this position partners closely with internal teams and external contract research organizations to produce phase-appropriate documents from early-stage development through late-stage clinical and pre-approval activities.
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 (e.g., Development Safety Update 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
Requirements
- Bachelor’s degree in life sciences, pharmacy, or a related scientific discipline with 4+ years of relevant regulatory/clinical medical writing experience in the pharmaceutical or biotechnology industry; or an advanced degree (M.S., Pharm.D., or Ph.D.) with correspondingly relevant experience
- Demonstrated experience authoring clinical-regulatory documents (e.g., protocols, CSRs, IBs, or clinical submission sections) within a GCP environment
- Strong working knowledge of ICH-GCP, ICH E3 (clinical study report structure), the CTD/eCTD framework, and regulatory requirements for clinical documentation
- Excellent scientific and technical writing skills, with the ability to translate complex clinical and statistical data into clear, accurate, and well-organized documents
