Full-Time

Director – Regulatory/Medical Writing

Confirmed live in the last 24 hours

Arrowhead Pharmaceuticals

Arrowhead Pharmaceuticals

501-1,000 employees

Develops RNAi-based therapies for gene targeting

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

Arrowhead Pharmaceuticals

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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

6 month growth

10%

1 year growth

26%

2 year growth

65%