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
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.
- 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.