Senior Associate, Clinical Trial Disclosure

Lake County, IL, US
Dec 02, 2018
Required Education
Bachelors Degree
Position Type
Full time
  • Completes writing activities to assist in ensuring timely disclosure of accurate, consistent, aligned and complete information globally.
  • Provides medical writing expertise for multiple compounds and/or projects within a therapeutic area.
  • Operationalizes changes in regulatory requirements via participation in the development and implementation of Standard Operating Procedures (SOPs)/processes, creating efficiency improvements/system automation and communication and training activities.
  • Communicates deliverables, writing process and timelines effectively across functional areas and within department to accomplish project objectives.
  • Coordinates the review, approval, and other appropriate functions involved with the registration and writing of clinical trial results disclosure public postings.
  • Accountable for completing the assigned studies within established timelines and with an appropriate quality level. Held accountable for driving writing projects and registration activities to timely completion.
  • Identifies conflicts and resolves or elevates them to management to ensure resolution.
  • Holds team members accountable to agreed-upon project dates. Negotiates with functional areas on project outcomes and deliverables to meet conflicting demands (time, deliverables, etc.).
  • Exhibits a moderate level of technical competencies and requires a low level of counsel and guidance.
  • Continually trains/is compliant with all current industry requirements as they relate to clinical trial disclosure and various regulated agencies.

  • Bachelor's degree or equivalent relevant experience is required preferably in nursing, pharmacy or scientific field.
  • Must have 3 years of clinical research experience or experience in a related area such as quality, regulatory, compliance, clinical research, or drug development.
  • 2-3 years relevant industry experience in medical writing in the healthcare industry or academia preferred; American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Editing/Writing or Pharmaceutical.
  • Knowledge of generally accepted project management practices. Demonstrated success in managing broad scope projects involving cross-functional teamwork.
  • Excellent communication (written and verbal), organization, planning, execution, and team leadership skills are required. Relationship management, communication ability, influencing skills required.
  • Ability to successfully operate in an international environment and experience building effective working relationships across geographic locations.
  • Working knowledge of US and international regulations requirements and guidance associated with scientific publications or clinical regulatory document preparation and submissions.
  • Working knowledge of current electronic document management systems and information technology. Proficient with major Microsoft suite programs.
  • Ability to assimilate and interpret scientific content and translate information for appropriate audience.
  • Superior attention to detail. Ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity and accuracy.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled