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← Entrada Therapeutics

Director, Regulatory Writing

Entrada Therapeutics
Location
Boston, MA
Posted
19 days ago
Department
Regulatory Affairs
Salary
$220,000 - $249,711
What they actually want (must-haves)
  • BS or MS with at least 7 years of increasing responsibility as a regulatory/medical writer
  • Strong work ethic and excellent communication skills
  • Demonstrated track record in medical writing within the pharmaceutical, biotech, or CRO industry
  • Expertise with Microsoft Word and eCTD-compliant formatting requirements
  • Proficiency in organizing and interpreting complex scientific and clinical data
  • Strong understanding of relevant ICH, GCP, and FDA regulatory standards
Nice to have
  • Experience working within a biotech company while managing external resources
  • Experience with rare diseases, pediatrics, genetic medicines, or leveraging expedited development pathways
  • Experience within Duchenne muscular dystrophy or neuromuscular therapeutic areas.
What the job really is

As the Director of Regulatory Writing at Entrada Therapeutics, you will lead the generation of high-quality regulatory documentation to support the advancement of the company's clinical pipeline. This role involves planning and managing the authoring of various regulatory submission components, collaborating with cross-functional teams, and ensuring effective communication with external writing providers. You will also be responsible for developing internal processes and standards critical to regulatory writing.

Benefits
  • Comprehensive health, dental and vision coverage
  • Life and disability insurance
  • 401(k) match
  • Paid, gender-inclusive parental leave
  • Holistic support for health and well-being
  • Education reimbursement
Things to weigh
  • No specific mention of remote work flexibility despite the #LI-Remote tag
  • The salary range is stated but may vary based on various factors, which could lead to uncertainty for candidates.
  • The role requires a strong commitment to collaboration and a proactive attitude, which may not suit all candidates.
Job score4.2/5
Benefits4/5
Freshness4/5
Career value4/5
Role clarity4/5
Pay transparency5/5

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