Director, Regulatory Writing

Entrada Therapeutics•Boston, MA

14h•$220,000 - $249,711•Remote

About The Position

The Regulatory Affairs team at Entrada is a dynamic, growing team. The Director of Regulatory Writing will coordinate and lead the efficient generation of high-quality regulatory documentation to support advancing Entrada’s pipeline, from preclinical through the clinical and registration stages. Reporting to the Senior Vice President, Regulatory Affairs, the successful candidate will support the development of strong internal processes, be the key liaison with external writing providers, serve as a lead author and document specialist, and support documentation planning and submission activities. This high-impact role will be critical to the success of the Regulatory department and Entrada’s mission to discover, develop and commercialize life-changing medicines that are safe, effective and accessible to those who need them. The successful candidate will have a demonstrated track record as a lead writer for a broad range of documents representing various stages of global development, an ability and desire to coordinate regulatory documentation across Entrada’s growing portfolio, and working collaboratively with departmental and cross-functional colleagues.

Requirements

BS or MS with at least 7 years of increasing responsibility as a regulatory / medical writer; education in a scientific field is a plus.
A strong work ethic, excellent communication skills, and a desire to work collaboratively with matrixed project teams.
A demonstrated track record in medical writing within the pharmaceutical, biotech, or CRO industry, particularly in creating and updating documentation for clinical development. Experience working within a biotech company while managing external resources is a plus.
Expertise with Microsoft Word and eCTD-compliant formatting requirements.
Proficiency in organizing and interpreting complex scientific and clinical data.
A strong understanding of the relevant ICH, GCP, and FDA regulatory standards governing regulatory documentation.
Excellent project management skills and the ability to work on multiple projects with tight timelines.
A motivated and driven attitude, with a proactive work style and a results-oriented mindset.
Integrity, a desire to learn and grow, and a commitment to excellence.

Nice To Haves

Experience with rare diseases, pediatrics, genetic medicines, or leveraging expedited development pathways is strongly preferred.
Experience within Duchenne muscular dystrophy or neuromuscular therapeutic areas is a plus.

Responsibilities

Leads the planning and management for the authoring of regulatory submission components from the pre-clinical through registration phase, including clinical protocols and amendments, Investigator's Brochures, Development Safety Update Reports, clinical study reports, health authority meeting requests and briefing documents, and summary documents for IND, CTA, CTR, and NDA submissions.
Leverages and efficiently manages external resources to ensure efficient execution of regulatory writing activities while ensuring effective communication with internal contributors and stakeholders.
Serves as a lead author and/or document expert to maximize quality and efficiency of critical deliverables.
Represents Regulatory Writing on cross-functional teams, working in close partnership with subject matter experts, Regulatory Affairs, and Program Management.
Expands processes and standards that are critical to Regulatory Writing, including development, maintenance, and improvement of SOPs, authoring guides, and project management tools.
Collaborates with Regulatory Affairs team to support submission-related activities.
Develop strong working relationships with Regulatory colleagues and cross-functional project teams, as well as external stakeholders, to support achievement of timelines and portfolio deliverables.