Primary job role

The Regulatory/Medical Writing Consultant will be responsible for Regulatory technical writing (clinically focused) to support development of clinical documents in accordance with ICH/E6/GCP guidelines to support US/EMA submissions, clinical trial applications, and clinical consultation responses. The incumbent should be able to work independently implementing and executing the programming and project standard to support ongoing clinical studies and requests for study report, regulatory submission, and ad hoc/post hoc analysis.

Responsibilities

• 1. Partner with multiple internal groups including Clinical, Regulatory Affairs, Pharmacovigilance, Biometrics, Clinical Operations and Medical Affairs and work cross functionally with other leaders.

• 2. Lead internal team/external teams/consultants for delivery of high-quality documents in accordance with applicable regulations and internal requirements

• 3. Ensure appropriate communication and involvement across functions, internal/stakeholders to create clear accountability for high quality, multidisciplinary documents submitted to regulatory agencies

• 4. Ensure consistency across different documents for the clinical program

• 5. Provide training and communications to different medical writers working on different documents for clinical program

• 6. Provide training to internal stakeholders and providers regarding medical writing process, best practices, and process improvements.

• 7. Monitor benchmarks with industry peers and across other industries to establish and update best practices and KPIs

• 8. Optimize and lead medical writing strategies, processes, and procedures

• 9. Recognize and implement efficiencies identified through process improvements

• 10. Establish and standardize Medical Writing practices/systems/tools

Requirements

• 1. Bachelor’s, Master’s or PhD in science/biological or healthcare.

• 2. 7+ years’ experience in clinical development that includes writing of clinical technical documents and a strong understanding of ICH/E6/GCP guidelines.

• 3. Primarily seeking an experienced Clinical author to support FDA submissions New INDs.

• 4. Pediatric Plans, Fast Track Applications, Breakthrough Therapy Applications, Orphan Drug Applications, responses to FDA requests, Meeting Request and Packages, and NDA/BLA submissions

• 5. Ability to interpret data and advice from regulatory authorities objectively, often in the face of strongly held competing views.

• 6. Extensive experience of all phases of the drug development process in regulatory affairs, including projects with little or no precedence.

• 7. Extensive knowledge of being able to develop product/therapeutic knowledge in a new area.

• 8. Previous experience independently authoring clinical modules for FDA submissions is required. EU submissions experience is a plus.