Regulatory Medical Writer - Temporary

ChemoCentryx is a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics to treat autoimmune diseases, inflammatory disorders and cancer, primarily focused on orphan and rare diseases. ChemoCentryx balances a passion for science with the deep-seated belief that patients suffering from serious diseases deserve more than incremental improvements to the length and quality of their lives.

 * This is temporary position for approximately 10 hours per week for 8 weeks.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Acts as lead for assigned writing projects.
• Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.
• Develops or supports a variety of documents that include, but are not limited to:
  • Briefing Packages for FDA meetings Must have experience with:
  • Breakthrough/Fast Track designation
  • Pre-IND, EOP2 briefing requests
• Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.
• 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 data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
• Serves as peer reviewer on internal QC review team providing review comments on draft and final documents.
• Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget.
• Performs on-line clinical literature searches, as applicable.
• Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.
• Maintains awareness of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.
• Completes required administrated tasks within the specified timeframes
• Performs other work-related duties as assigned. Minimal travel may be required (less than 25%).

REQUIREMENTS

• Science based PhD based preferred. Bachelor of Science degree with relevant biotech, regulatory writing experience will be considered.
• Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide.
• Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team-oriented approach.
• Strong proficiency in Word, Excel, PowerPoint, email, and Internet.
• Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information.

PREFERRED EXPERIENCE

• Oncology or Immunology experience preferred.
• Starting Point Template experience a plus.