The Perfect Addition to Our Team

You have a resourceful, collaborative, and versatile approach to work and bring extensive medical writing expertise. You are comfortable interacting with cross functional stakeholders and have a keen eye for detail. You are someone who thrives in a start-up environment, and have the ability to identify potential solutions to current and future challenges.

The Opportunity

The Associate Director, Regulatory Writing will be a key contributor to global development and regulatory activities for Entrada’s pipeline, including preclinical and clinical-stage assets. Reporting to the Head of Regulatory Writing, the successful candidate will play a pivotal role in the development of high-quality documents across the portfolio. The ideal candidate will have a strong background in regulatory writing, particularly in creating and updating clinical trial documents, and a passion for working collaboratively with cross-functional development teams.

Responsibilities

• Author and manage clinical regulatory documents, such as Clinical Protocols (Phase 1-3 and specialty clinical pharmacology protocols), Protocol Amendments, Clinical Study Reports (CSR), narratives, Clinical and Safety Summaries, DSURs, Investigator's Brochures (IBs) and IB updates, and Informed Consent Forms (ICFs).
• Contribute to the planning and management of cross-functional regulatory submission components (clinical, nonclinical, CMC), including meeting requests, briefing documents, IND/CTA/NDA/MAA documents for products in the company portfolio.
• Represent Regulatory Writing on cross-functional teams, working in close partnership with regulatory affairs, clinical and nonclinical subject matter experts (SMEs) from pharmacology, drug metabolism and pharmacokinetics (DMPK), toxicology, and other internal stakeholders and external collaborators/CROs.
• Develop and implement processes and standards in regulatory writing, including model documents, documentation trackers, authoring guides, SOPs, etc.
• Maintain adherence to standard operating procedures and regulatory requirements in partnership with colleagues from statistical, clinical, nonclinical, regulatory, quality, and drug safety functions.

The Necessities

At Entrada, our passion for science, our devotion to patients and our values drives our behavior:

• Humanity - We genuinely care about patients and about one another.
• Tenacity - We are relentless and persistent in the pursuit of developing therapies for patients.
• Creativity - We are creative problem solvers.
• Collaboration - We are more than the sum of our parts.
• Curiosity - We have a growth mindset and push conventional thought and theory.

To thrive on our team, you will need to come with:

• Bachelor's or advanced degree in a scientific discipline, life sciences, pharmacy, or related field.
• 7 years of relevant clinical medical writing experience in the pharmaceutical industry, biotech, or CRO.
• Proficient in organizing and interpreting complex scientific and clinical data.
• Experience in the rare disease space is strongly preferred.
• Understanding of ICH/GCP guidelines, FDA regulations, and other relevant regulatory standards governing clinical trial documentation.
• Ability to work collaboratively in a cross-functional team environment, and to manage multiple projects and priorities.
• Proficiency with Microsoft suite and experience with eCTD-compliant formatting and relevant editing and documentation management software.