Senior Manager, Commercial Congress Strategy and Execution
Cogent Biosciences
Vault
Principal Medical Writer
Arcus Biosciences
full-time
Posted on:
Location Type: Remote
Location: Remote • California • 🇺🇸 United States
Visit company websiteSalary
💰 $165,000 - $185,000 per year
Job Level
Lead
Tech Stack
Vault
About the role
- Independently prepares, edits, and finalizes Protocols including amendments, addenda, and notes to file, original and updated Investigator’s Brochures, Clinical Study Reports (full and abbreviated), as well as other regulatory documents (INDs/NDAs, annual reports, Orphan Drug Designation applications, Agency Response to Questions, Briefing Books) with minimal input.
- Coordinates and leads comment adjudication meetings.
- Develops, manages, and communicates project timelines.
- Ensures appropriate and effective collaboration with key functional contributors and adherence to ICH and other regulatory requirements, in addition to internal Arcus document standards.
- Reviews statistical analysis plans and table/figure/listing specifications for appropriate content and to align key messaging for CSR and submission document development.
- Serves as MW point-of-contact to internal cross functional teams and Arcus partners in support of medium-to-large development programs and initiatives.
- Participates in MW and cross-functional process improvement initiatives on clinical document standards, template development, and document or MW processes.
- Reviews documents written by less experienced or contract medical writers.
- Coordinates Quality Review (QR) of documents, addresses comments, and maintains audit trails of changes.
- May perform QR review if requested (eg, QR in-text tables against statistical tables, verify titles in standard table of contents, paginate a document, etc).
- Coordinates communication with document processing and ensures template formatting aligns with Arcus quality standards.
- May provide oversight of vendors, vendor resources, and contracts.
Requirements
- Minimum of Bachelor’s and/or Master’s degree in life sciences; PhD preferred.
- Minimum of 4 years Regulatory Writing experience in a pharmaceutical, biotech, or CRO environment; experience in oncology is desired.
- Excellent verbal communication and technical writing skills including tact and diplomacy in dealing with complex projects and teams.
- Demonstrates autonomy and has ability to negotiate and collaborate within a cross‑functional team environment.
- Demonstrates success in the preparation of clinical/regulatory documents at the individual document and submission level.
- In-depth knowledge of industry regulations, guidance, and regulatory documentation requirements including thorough knowledge of ICH guidelines.
- Experience interacting and communicating timeline expectations with cross functional study team members.
- Expert/highly proficient in the functionality of MS Word, Excel, Adobe Acrobat, and PowerPoint.
- Experience with Veeva Vault and/or other document management systems.
- Familiarity with statistical analysis concepts and techniques preferred.
Benefits
- participate in stock programs
- a performance-based bonus
- a comprehensive benefits package
- Additional information about our total rewards program can be found here: https://arcusbio.com/careers
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Regulatory WritingClinical Study ReportsStatistical Analysis PlansDocument FormattingClinical/Regulatory Document PreparationProject Timeline ManagementQuality ReviewTemplate DevelopmentOncology KnowledgeICH Guidelines
Soft skills
Verbal CommunicationTechnical WritingNegotiationCollaborationAutonomyTact and DiplomacyCross-Functional TeamworkProcess ImprovementLeadershipAttention to Detail
Certifications
Bachelor’s Degree in Life SciencesMaster’s Degree in Life SciencesPhD in Life Sciences
