Senior Medical Writer
The Sr. Medical Writer (SMW) will prepare clinical/regulatory documents to support regulatory submissions and contribute to the development of internal Arcus MW processes with input from a more senior medical writer. The SMW will help plan and have oversight (with guidance from a more senior medical writer) for medical writing deliverables for a wide variety of small-to-medium clinical/regulatory submissions from early-to-late phase development.
All responsibilities will have input from a more senior medical writer, as needed.
- Prepare, edit, and finalize low-medium complexity protocols including amendments, original and updated investigator brochures, synopses, clinical study reports (full and abbreviated).
- Ensure appropriate and effective collaboration with key functional contributors and that all documents are authored according to regulatory requirements, internal Arcus document standards (utilizing the Arcus Manual of Style), and with adherence to timelines and team expectations.
- May serve on medium-to-large development programs supporting MW on cross-functional initiatives/teams supporting key objectives
- Participates in medical writing and cross-functional process improvement initiatives on clinical document standards, template development, and document or medical writing processes
- Reviews documents written by contract medical writers
- BA/BS and 4+ years of relevant experience (less with advanced degree and relevant industry experience); post-graduate degree preferred
- Relevant experience includes clinical R&D, regulatory affairs, or related industry/academic experience, with 3+ years of direct experience in a medical writing/clinical submissions environment directing/preparing document for regulatory submissions; Medical writing experience in oncology or rare diseases is desired
- Excellent verbal communication and technical writing skills
- Shows leadership and autonomy and has ability to negotiate and collaborate within a cross‑functional team environment with minimal oversight from a more senior medical writer
- Demonstrates success in the preparation of clinical/regulatory documents at the individual document and submission level
- A thorough understanding of industry regulations, guidance’s, and regulatory documentation requirements
- Provides medical writing expertise for clinical/regulatory documents and submissions of low to medium complexity
- Experience interacting and communicating timeline expectations with cross functional study team members
- Highly proficient in the functionality of MS Word, Excel, Adobe Acrobat, and PowerPoint
- Experience with electronic document management systems (e.g., Veeva Vault) preferred
- Familiarity with statistical analysis concepts and techniques preferred