Medical Director (Contract)

Added
11 days ago
Type
Contract
Salary
Salary not provided

Related skills

regulatory affairs clinical research medical writing ctms fda

πŸ“‹ Description

  • Provide strategic medical input into current and potential clinical projects, including proposal
  • Apply in-depth knowledge of the endocrinology clinical research landscape to support study strategy
  • Contribute to protocol development, study plans, regulatory annual reports, clinical study reports
  • Support FDA interactions and regulatory activities, including IND-related pre-submission and Type
  • Support medical monitoring and the management of medical aspects of clinical trials.
  • Review and address site and CRA questions related to inclusion and exclusion criteria.

🎯 Requirements

  • Licensed MD or PhD with a background in endocrinology or a related field.
  • At least 2 years of clinical trial experience as a medical monitoring associate or in an equivalent
  • Demonstrated experience supporting clinical trial strategy and FDA submission activities.
  • Experience with protocol development and medical writing for protocols and clinical study reports.
  • Strong understanding of FDA interactions and clinical regulatory processes.
  • Endocrinology expertise required; pediatrics and metabolic trial experience are preferred.

🎁 Benefits

  • Competitive compensation with variable pay opportunities.
  • Paid time off.
  • Healthcare benefits.
  • Retirement benefits.
  • Part-time, hourly contract employment.
  • Remote work within the United States.
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