Regulatory Medical Writer - Temporary

Employment Type

: Full-Time

Industry

: Miscellaneous



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.

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