What are the responsibilities and job description for the Associate Director Clinical Regulatory Writing position at ProKatchers LLC?
Job Title: Associate Director Clinical Regulatory Writing
Location: Boston, MA – 02210
Duration: 12 Months
Job Description:
- Independently manage clinical regulatory writing activities across a complex portfolio of work.
- Author the most complex clinical-regulatory documents within a program by ensuring that relevant regulatory, technical and quality standards are achieved, and that relevant processes and best practice are applied.
- As part of a clinical delivery or submission team, provide strategic communications leadership to projects, establish communication standards and best practice, and continuously advocate for quality and efficiency.
- When acting as a submission lead, drive the development of the Clinical Submission Communication Strategy (cSCS).
- Lead internal/external authoring teams and provide strong partnership with vendor medical writers to ensure delivery to time and quality.