Senior Associate, Clinical Trial Disclosure

  • location: North Chicago, IL
  • type: Contract
  • salary: $40 - $47.37 per hour
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job description

Senior Associate, Clinical Trial Disclosure

job summary:
As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A current top partnership with a research-driven biopharmaceutical company is known as a powerhouse that aims to develop treatments for difficult-to-cure diseases. This renowned employer has created 32 products, including Humira and Lupron, that have highly impacted lives across the globe. If you're looking to stand out in your field and lead the way to innovative therapies, this position is for you!

 
location: North Chicago, Illinois
job type: Contract
salary: $40.00 - 47.37 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
  • 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.
 
qualifications:
  • 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.
 
skills: MS-WORD, MS-EXCEL, CTD Structure
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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