A Biotechnology sponsor company is looking for a Sr. Medical Writer for a 12 Month Contract that starts in 2024.

Overview

You will be responsible for creating, authoring, and leading the management of key documents for programs, regulatory filings, clinical studies and external publications, such as clinical protocols (and amendments), clinical study reports, subject consent forms, investigator’s brochures, product dossiers, integrated safety and efficacy summaries, and other documents required for regulatory submissions, abstracts, posters and manuscripts.

In this position, you will collaborate with and actively participate in cross-functional teams including representatives from clinical operations, data sciences, regulatory affairs, medical, biostatistics, pharmacovigilance/safety, new product planning, program management, and corporate communications. In addition, you may partner with Key Opinion Leaders (KOLs), Contract Research Organizations (CROs), and co-development partners.

Responsibilities:

• Coordinate development of, and serve as principal writer for, clinical protocols/amendments, clinical study reports, investigator brochures, Module 2 summaries and other elements of regulatory submissions

• Organize and lead document development and review meetings

• Develop and ensure adherence to clinical and regulatory writing timelines, standards and processes

• Critically review statistical analysis plans to ensure alignment with anticipated data presentations in clinical study reports and Module 2 summaries

• Perform literature-based research to support writing activities

• Lead medical writing and cross-functional initiatives pertaining to document standards, template development, and processes

Qualifications:

• At least 6 years of clinical/regulatory medical writing experience in the pharmaceutical or biotech industry

• An understanding of the drug development process including clinical study conduct, data collection and analysis, and interactions essential to regulatory submissions

• Knowledge of ICH guidelines, GxP, and relevant regulatory requirements

• Demonstrated understanding of standard clinical document types (i.e., protocol, investigator’s brochure, clinical study reports, etc.) and experience as a lead author with such documents

• A Bachelors, Masters, PharmD or Ph.D. in a life science or health discipline