Principal Strategic Medical Writer (Oncology)

AbbVieNorth Chicago, IL
81d$144,715 - $202,500Remote

About The Position

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio.

Requirements

  • Must have a Bachelor's degree in a scientific discipline or foreign education equivalent.
  • 5 years of academic &/or industry medical writing experience.
  • 3 years of experience preparing & presenting written & oral scientific presentations to peers, business stakeholders & management.
  • 3 years of experience interpreting statistical data to prepare written medical and scientific reports for regulatory bodies.
  • 3 years of clinical regulatory writing experience following regulations ICH & FDA regulatory requirements.
  • 3 years of experience working with stakeholders in drug development, clinical research, study designs, & biostatistics to author clinical regulatory documents.
  • 3 years of experience performing medical writing in the bio-pharmaceutical industry.
  • 3 years of experience managing project delivery timelines.

Responsibilities

  • Serve as a lead on complex clinical & regulatory documents.
  • Work closely with the team(s) on document authoring & content strategies.
  • Coordinate review, approval, & quality control of other functions involved in the production of clinical & regulatory projects.
  • Communicate deliverables needed, writing process, & timelines to team members.
  • Hold team members accountable to agreed-upon project dates.
  • Work independently with Regulatory Quality Assurance to address inquiries & draft responses.

Benefits

  • Paid time off (vacation, holidays, sick)
  • Medical/dental/vision insurance
  • 401(k) to eligible employees
  • Short-term and long-term incentive programs

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What This Job Offers

Job Type

Full-time

Career Level

Mid Level

Industry

Chemical Manufacturing

Education Level

Bachelor's degree

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