Senior Director, Regulatory Writing and Operations

Stoke Therapeutics, Inc.•Bedford, MA

50d•$262,000 - $299,000•Hybrid

About The Position

The Senior Director, Regulatory Writing and Operations oversees the strategic direction and management for both the Regulatory Writing and Regulatory Operations functions within Stoke. This position is responsible for the preparation, collaborative authoring, and completion of ICH-compliant regulatory documents, including those for clinical. Additionally, this position oversees submission and document management, publishing, and the Regulatory Information Management System (RIM). Demonstrates excellent understanding of drug development and leadership behaviors consistent with level. This position will report into the Chief Regulatory Officer.

Requirements

In-depth knowledge of industry requirements and best practices policies for clinical regulatory documents (e.g., GCP, ICH).
Sound working knowledge of writing, publishing and RIM computer applications
Excellent written and oral communication skills.
Ability to manage teams and individuals.
A BS/BA degree or equivalent, and a minimum of 10 years' experience in Medical or Regulatory Writing.
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
Proven ability to lead complex projects, with flexibility and adaptability.
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects

Responsibilities

Partners with stakeholders to author complex regulatory documents including but not limited to; clinical study protocols, clinical study reports, investigator's brochures, regulatory briefing packages, regulatory responses, and sections of marketing authorization applications.
Develop and manage SOPs, editorial standards, internal templates, and style guides.
Partner with peers to increase visibility of upcoming submissions and deliverables across the regions.
Work directly with team members to communicate and drive timelines, lead document review and roundtable discussions.
Provide expert review of study-level and program-level documents for consistency in messaging and formatting.
Effectively manage workloads and product quality of internal and contract medical writers.
Direct the development and implementation of standards (SOPs and work processes) for dossier development, management, publishing, archiving, metrics, and submission process.
Accountable for QC and validation of submissions to ensure they are error-free from a regulatory validation standpoint and are submitted on time to meet any internal or external requirements.
Oversee maintenance, validation, implementation and training on operations systems.
Drive continuous process improvement and increased communications across regulatory through leadership of initiatives to capture learnings, integration of new tools and technologies, and identify opportunities for change.
Lead or participate in process improvement or operational excellence initiatives within Regulatory function or Stoke in general, as applicable.