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Medical Writer II - Clinical

Abbott Park, ILRandstad LifeSciences

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Job Title:  Sr CTD Associate

Position Description

  • Responsible for providing writing support to clinical trial results disclosure public postings of clinical trial data/information and meeting required deadlines.  Also responsible for the planning and execution of clinical drug trial registrations per the applicable regulatory requirements.  Ensuring successful preparation of high quality postings and effective implementation of the clinical writing process.

Position Responsibilities

  • Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
  • 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.
  • Operationalizing changes in regulatory requirements via participation in the development and implementation of 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.
  • Identify conflicts and resolve or elevate 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 train/be compliant with all current industry requirements as they relate to clinical trial disclosure and various regulated agencies.

Position Requirements

  • 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.


  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

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