What are the responsibilities and job description for the Clinical Regulatory Writing Associate Director position at The Fountain Group?
Location: Remote
Pay Rate: $76/hr
Duration: 12 Months
Job Description
The Clinical Regulatory Writing Associate Director will lead clinical regulatory writing activities across a complex portfolio of pharmaceutical drug development programs. This role focuses on authoring complex, label-focused clinical-regulatory documents, interpreting clinical data, and driving strategic communications aligned with regulatory requirements, submission strategies, and quality standards.
Responsibilities:
Pay Rate: $76/hr
Duration: 12 Months
Job Description
The Clinical Regulatory Writing Associate Director will lead clinical regulatory writing activities across a complex portfolio of pharmaceutical drug development programs. This role focuses on authoring complex, label-focused clinical-regulatory documents, interpreting clinical data, and driving strategic communications aligned with regulatory requirements, submission strategies, and quality standards.
Responsibilities:
- Independently manage clinical regulatory writing activities across multiple drug development programs.
- Author complex clinical-regulatory documents in compliance with regulatory, technical, and quality standards.
- Lead strategic communications for clinical development and regulatory submission teams.
- Develop the clinical Submission Communication Strategy (cSCS) when acting as submission lead.
- Lead internal and external authoring teams and oversee vendor medical writing deliverables.
- Interpret complex clinical data and translate findings into clear, accurate, label-focused messages.
- Conduct strategic reviews of clinical-regulatory documents and drive continuous improvement in writing processes.
- Support the development of Clinical Regulatory Writing Managers.
- Master’s degree in Life Sciences or an appropriate scientific discipline required.
- Ph.D. in a scientific discipline preferred.
- Significant medical writing experience in the pharmaceutical industry or CRO.
- Clinical regulatory writing and complex regulatory document authoring.
- Drug development knowledge across clinical development, launch, and lifecycle management.
- Clinical data interpretation and label-focused regulatory communications.
- Clinical Submission Communication Strategy (cSCS) development.
- Regulatory, technical, and quality requirements for clinical-regulatory documentation.
- Clinical regulatory submission support and strategic document review.
- Vendor medical writing oversight and authoring team leadership.
- Ph.D. in a scientific discipline.
- Experience supporting complex clinical development programs across multiple therapeutic areas.
- Experience driving clinical regulatory writing process improvements and operational excellence.
Salary : $76