Technical Data Reviewer & Coordinator

Radius Health

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Technical Data Reviewer & Coordinator

US--

Job ID: 2021-2173
Type: Regular Full-Time
# of Openings: 1
Category: Pharmaceutical Development/Operations

Overview

This newly created position will collaborate across the Clinical Development and Pharmaceutical Sciences team to support technical data review for multiple sNDA/NDA submissions within the next year. It is a unique learning opportunity to work across all development areas required for an NDA submission.

This position will play a key role to organize, compile, maintain and review technical data and reports that underpin the sNDA/NDA submission. The role will also support and co-ordinate contract review and financial aspects of our work with CRO/CMOs.



Responsibilities

We are looking for an energetic, self-motivated individual that is interested in learning more about NDA/sNDA submissions across all development functions. They will have strong attention to detail and be quality oriented. In addition to an interest in the scientific disciplines they will also be willing to learn more about contracts and financial interactions with CRO/CMOs

The ideal candidate has 3+ years experience generating data in the GMP/GLP environment but is ready to step away from the laboratory/manufacturing environment.

The role will enable candidates to gain a broad range of experiences across clinical, pre-clinical and pharmaceutical development as multiple projects approach NDA/sNDA submissions.



Qualifications

  • Minimum of B.S. Degree in scientific discipline with 3+ years of experience in biotech, clinical, or equivalent science based laboratory/manufacturing environment.
  • Working knowledge of GMPs.
  • Ability to work independently or as part of a team.
  • Be able to interact with other analysts when corrections are identified as part of the data review process.
  • Excellent inter-personal, communication and organizational skills with excellent attention to detail.

PM18





PI138658873

Company
Radius Health
Posted
06/08/2021
Type
Full time
Salary Range
$58,000.00 - 104,000.00
per Year
Salary range estimated by
Location
Boston, MA 02108, US