Senior Director, Medical Writing
Summary
The Senior Director, Medical Writing will work collaboratively with Arcus’s regulatory, clinical and scientific teams to produce high quality documents to support the company’s drug development programs. They will focus on the preparation of regulatory and clinical documentation for submission to global regulatory agencies and assist with the preparation of publications, abstracts, and other external and internal communications. They are responsible for developing and implementing processes and standards to ensure company documentation is prepared to the highest editorial standards and quality.
Responsibilities:
- 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.)
- Manage internal and external medical writers
- 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 standard
- Ensure documentation conforms to International Conference on Harmonization (ICH) and other relevant regulatory guidelines and medical editorial boards
- Ensure appropriate documented quality control (QC) checks are performed and recommend quality process improvements
- Ensure documents are generated in accordance with agreed internal processes and standards, are submission ready, and are stored in appropriate document management system(s)
Qualifications:
- Bachelor’s degree in medical-related field or life science required; post-graduate degree (master’s or doctoral) preferred
- 8+ years of relevant medical writing experience in the pharmaceutical industry, preferably in the therapeutic areas of liver disease, oncology, or rare diseases
- Previous experience managing direct reports is highly preferred
- 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.
- 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
- Familiarity with statistical analysis concepts and techniques preferred