Your browser cookies must be enabled in order to apply for this job. Please contact support@jobscore.com if you need further instruction on how to do that.

Regulatory Medical Writer - Temporary

Regulatory | San Carlos, CA | Part Time and Temporary

Job Description

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.