Full-Time
Director – Regulatory/Medical Writing
Confirmed live in the last 24 hours
Develops RNAi-based therapies for diseases
Biotechnology
Senior
Pasadena, CA, USA + 1 more
Required Skills
Management
Word/Pages/Docs
PowerPoint/Keynote/Slides
Requirements
- Bachelor’s degree in medical-related field or life science
- A minimum of 6-8 years of relevant medical writing experience in the pharmaceutical industry
- Thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research and medical writing standards; demonstrated ability to interpret and apply these guidelines to document writing
- A demonstrated track record of contribution to successful regulatory components used in filings e.g. IND/CTAs, NDA/BLA/MAAs is important
- Experience interacting and communicating timeline expectations with cross functional study team members
- Experience with electronic document management systems
- Highly proficient in the functionality of MS Word, Excel, Endnote, Adobe Acrobat, and PowerPoint
- Experience managing Medical Writer staff member(s)
Responsibilities
- Lead Medical Writing Team
- Prepare, edit, and finalize protocols, investigator brochures, synopses, clinical study reports, regulatory documents (INDs/NDAs, annual reports, Orphan Drug Designation applications, Agency Response to Questions, briefing books, etc.)
- Collaborate with the clinical and scientific staff for narrative and data presentation planning, gather material for relevant documents and ensure that documents accurately reflect sources
- Manage the document review process and schedule and conduct meetings to ensure documentation timelines are achieved
- Prepare abstracts, posters, presentations, and manuscripts; assist in the development and maintenance of quality and product documentation
- Advise and assist in the review and management of nonclinical and CMC technical reports
- Develop and maintain Company house-standard templates and best review practices for regulatory and clinical documentation; ensure vendors and contractors maintain company standards
- Ensure that documentation conforms to International Conference on Harmonization (ICH) and other relevant regulatory guidelines and medical editorial boards; ensure that appropriate documented quality control (QC) checks are performed and recommends quality process improvements
- Ensure documents are generated in accordance with agreed internal processes and standards, are submission ready, and are appropriately stored in appropriate document management system(s)
Arrowhead Pharmaceuticals specializes in developing RNAi-based therapies using their TRiM platform, which leverages various RNA chemistries for tissue-specific targeting, enabling rapid and durable knockdown of disease-causing genes. The TRiM platform also utilizes ligand-mediated delivery, offering potential advantages such as simplified manufacturing, reduced costs, and improved safety.
Company Stage
IPO
Total Funding
$899.9M
Headquarters
Pasadena, California
Founded
2004
Growth & Insights
Headcount