Medical Writer

Duration: 06 Months+

The Medical Writer for Clinical Procedures works with Process Owners, Subject Matter Experts (SMEs), and relevant stakeholders to develop new and revise existing clinical procedures. The Medical Writer ensures procedures and associated forms and templates are written to a high-quality standard and according to Client’s writing style guide and standards for clinical procedures/documents. The Medical Writer manages document reviews and adjudication of review comments on procedures and associated forms and templates by liaising with the Process Owners, SMEs, and the QC reviewer. The Medical Writer drives the writing of clinical procedural documents by working across global cross-functional teams and ensures that timelines and customer/stakeholder needs are met. Medical Writer accurately 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.
• A 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.

Shift: Day