Medical Writer

  • Temporary/Contract Positions
  • Remote

Website UserEdge Technical Personnel

Work Type:  Contract Role

Work Location: REMOTE (looking for candidates either in New Jersey or Pennsylvania only)

Pay Rate:  $90-$105 per hour

Duration: February 12 – August 9, 2024 (with potential for extension)

Job Hours: Full time, 8 hours per day, five days a week

Job Description:

We have a contract role open for an experienced Medical Writer with a Bachelor’s degree or higher and at least 8 years of experience working in the pharmaceutical industry.

The Medical Writer will perform the following tasks:

  • Drives the writing of clinical procedural documents by working across global cross-functional teams (Process Owners, Subject Matter Experts and relevant stakeholders) and ensures that timelines and customer/stakeholder needs are met.
  • Ensures procedures and associated forms and templates are written to a high-quality standard and according to the company’s writing style guide and standards for clinical procedures/documents.
  • Manages document reviews and adjudication of review comments on procedures and associated forms and templates by liaising with the Process Owners, Subject Matter Experts, and the QC reviewer.
  • Tracks timelines and status of procedural document development and review and works with the administrator of the learning management system to ensure procedures are available for training.

Requirements

  • Bachelor’s degree required.
  • Proven medical writing experience, with at least 8 years working in the pharmaceutical industry; the ideal candidate will also have experience in writing SOPs/clinical procedures.
  • Strong working knowledge of all clinical development functions and processes, compliance standards, and ICH, GCP, and regulatory requirements.
  • Significant experience in applying writing style guidelines and standards.
  • Customer-focused approach, with strong project management and interpersonal skills and the ability to build relationships, resolve conflicts, and obtain buy-in necessary to achieve objectives.
  • Experience across multiple disciplines within clinical development in the pharmaceutical industry, with knowledge of the drug development process.
  • Proven experience in developing, maintaining, and using templates and working in an electronic document management system.
  • Excellent communication skills both oral and written at all levels.