Remote: Biostudy Consultant (233849)

Life Sciences & Technology
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Duration

3-6 Months Min

Job Description

The client needs someone who’s served in a Clinical Study Director capacity. Largely with PK, little with clinical endpoints. This contractor will help develop the questions for the FDA development—there have not been any ANDAs yet. The consultant will support the various ANDAs, and guide some of the work with the ANDAs.

Background

  •  10+ years working in Pharm/Bio
  • Direct biostudy experience
  • Must have experience being a CRO liaison
  • Knowledge of dosage approach for the products (e.g., SAD, MAD, crossover study,
  • Working with a highly-variable molecule terrible with PK, not reproducible with the branded (RLD).
  • Must be able to create smarter approaches and solutions for path forward

Remote: Biostudy Consultant (233849)

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About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Start Date
ASAP
Location
Remote

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