Associate Director, Medical Writing

1 month ago

Boston, United States Entrada Therapeutics Full time
The Organization

What's happening at Entrada Therapeutics? Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible.

Our Endosomal Escape Vehicle (EEV™)-therapeutics are designed to enable the efficient intracellular delivery of a wide range of therapeutics into a variety of organs and tissues, resulting in an improved therapeutic index. Through this proprietary, versatile and modular approach, Entrada is advancing a robust development portfolio of RNA-, antibody- and enzyme-based programs for the potential treatment of neuromuscular, ocular, metabolic and immunological diseases, among others.

Our lead oligonucleotide programs are in development for the potential treatment of people living with Duchenne who are exon 44, 45 and 50 skipping amenable. We have also partnered to develop a clinical-stage program, VX-670, for myotonic dystrophy type 1.

We are a tight-knit team of experts and leaders in both therapeutic development and rare diseases and are excited to grow and attract colleagues who are ready to join a high-energy, dedicated team that likes to get things done and dramatically improve the lives of patients and their families. 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. The Perks

By becoming a team member here at Entrada, you’ll have access to competitive health, dental, and vision coverage, as well as life insurance, and short term and long-term disability insurance. We value work life balance, you'll benefit from discretionary time off, paternity leave, and an excellent 401(k) package. We also offer a generous transportation stipend to commute as you wish. Our location in the vibrant and growing Seaport District is close to all the best that the city of Boston has to offer.

Entrada Therapeutics is an equal opportunity employer. Qualified candidates will receive consideration for employment without regard to race, color, religion, national origin, gender, sexual orientation, gender identity or expression, age, mental or physical disability, and genetic information, marital status, citizenship status, military status, protected veteran status or any other category protected by law. Third Party Staffing Agencies

Entrada does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Entrada from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Entrada and do not obligate Entrada to pay fees if we hire from those resumes. Privacy Statement

Entrada Therapeutics, Inc. (the “Entrada,” “we,” “us,” or “our”) respects your privacy and we want you to be familiar with how we collect, use, share, or otherwise process, your Personal Information. Please reference our privacy statement here to understand how and when your data is being used.

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