Senior Medical Writer

Posted Aug 6

Job Description

The Senior Medical Writer will work cross functionally with Arcus internal departments and external resources regarding medical writing (MW) activities. This includes, but is not limited to authoring, editing, and providing project management support for clinical regulatory documents including protocols, amendments, investigator’s brochures, and clinical study reports, as well as various other clinical and nonclinical documents.

Responsibilities

  • Manages and executes medical writing assignments, effectively communicates with cross-functional teams, including during adjudication meetings, and delivers high-quality ICH-compliant documents across a broad range of document types.
  • Ensures appropriate communication on project and program-related matters with Head of MW.
  • Authors and manages the authoring process for program documents (such as protocols, protocol amendments, investigator’s brochures, informed consent forms, patient narratives, clinical study reports, eCTD summary documents, and various other clinical regulatory documents).
  • Compiles, writes, and edits medical writing deliverables, and serves as a medical writer on inter-department and intra-department project teams with minimal supervision.
  • Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
  • Interacts with department head and staff members in clinical development and operations, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
  • Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, and Company approved templates.
  • Delivers projects on-time and to the highest standards of quality.
  • Performs on-line clinical literature searches, as requested.
  • Coordinates quality control (QC) reviews of documents and maintains audit trails of changes.
  • May perform QC review if requested (e.g., QC in-text tables against statistical tables, verify titles in standard table of contents, paginate a document, etc.)

Qualifications and Education

  • Minimum of Master’s degree in the life sciences; PhD preferred.
  • Minimum of 3 years of Regulatory Writing experience in a pharmaceutical, biotech, or CRO environment.
  • Expert word processing skills in MS Word, including proficiency with tables, graphs, and figures.
  • Must be able to work in a collaborative team environment.
  • Strong computer skills, project management skills, and a high attention to detail.
  • Excellent understanding of ICH and GCP guidelines and regulations.
  • Ability to write presentations and articles for peer reviewed publications that conform to prescribed style and format, as needed.
  • Knowledge of internet software, spreadsheet software, word processing software, graphics software (e.g., PowerPoint), bibliographic software e.g. EndNote) and any other applicable software as may be needed.
  • Must demonstrate strong experience in relationship-building and effective team collaboration.

This role is remote based. The anticipated salary range for fully qualified candidates applying for this position is $110,000 - $132,000 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.