Associate Director, Medical Writing

Job Summary

The Associate Director of Medical Writing (MW) is responsible for managing MW and quality control (QC) activities in accordance with the Head of MW in a timely, accurate, and efficient manner in compliance with company and global regulations, including ICH and GCP. The Associate Director, MW will work cross functionally with internal departments and external resources to author, edit, oversee, and provide project management support for clinical regulatory documents.

Responsibilities

• Coordinates and/or oversees coordination of QC reviews and maintenance of audit trails.
• Delivers projects on-time and to the highest standards of quality.
• Oversees cross-functional communication and deliverables for multiple project and program-related deliverables and initiatives, including creation and maintenance of timelines, as needed.
• Participates in MW and cross-functional process improvement initiatives on clinical document standards, template development, and document or MW processes.
• May perform or oversee QC review if requested (e.g., QC in-text tables against statistical tables, verify titles in standard table of contents, paginate a document, etc).
• Manages/oversees internal and contract medical writers to ensure adherence to the highest quality of MW and Arcus document standards. This may include coaching, training, and providing guidance to less experienced writers or contractors.
• In conjunction with the Head of MW, defines and manages MW and QC resource needs and effectively communicates with cross-functional teams.
• Independently prepares and finalizes or oversees finalization of 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.
• Ensures appropriate communication on project and program-related matters with the Head of MW.

Qualifications

• Minimum of 5 years of Regulatory Writing experience in a pharmaceutical, biotech, or CRO environment; experience in oncology or rare diseases is desired.
• Expert/highly proficient in the functionality of MS Word, Excel, Adobe Acrobat, and PowerPoint.
• Experience with electronic document management systems (e.g., Veeva Vault).
• Shows strong leadership and autonomy and has ability to negotiate and collaborate within a cross‑functional team environment.
• Minimum of Bachelor’s and/or Master’s degree in the life sciences; PhD preferred.
• In-depth knowledge of industry regulations, guidance, and regulatory documentation requirements including thorough knowledge of ICH guidelines.
• Excellent verbal communication and technical writing skills including tact and diplomacy in dealing with complex projects and teams.
• Familiarity with statistical analysis concepts and techniques preferred.
• Demonstrated success in the preparation of clinical and regulatory documents, as well as overseeing timelines and deliverables for direct reports or contracted writers.
• Experience interacting and communicating timeline expectations with cross functional study team members.

This role will be remote based. The anticipated salary range for fully qualified candidates applying for this position is $165,000 - 185,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position. The actual salary may vary based on various factors including, without limitation, individual education, experience, tenure, skills and abilities, internal equity and alignment with market data. In addition to a competitive market-based salary, Arcus offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package. Additional information about our total rewards program can be found here: https://arcusbio.com/careers
Arcus Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Arcus is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets
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