Senior Scientific Reviewer
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Job Classification: Technical/Regulatory


The Senior Scientific Reviewer position at PharmAssist, Inc. is responsible for reviewing, writing and editing a variety of scientific documents and reports based on analytical testing performed in the Laboratories. Assures that all aspects of our regulated laboratory activities are executed and documented in accordance with PharmAssist SOPs and FDA requirements. Acts as "peer reviewer" for complex, data-rich reports performed as R&D and cGMP projects.

Requirements: The Senior Scientific Reviewer will possess, at minimum a Bachelor's degree in science (e.g. chemistry, biology, biochemistry, etc.), with at least 5 years of regulated documentation experience in the pharmaceutical - analytical laboratory environment. Must have excellent attention to detail, written and verbal communication skills, be conversant with CFR 21 - current Good Manufacturing Practices (cGMP), and must be familiar with the latest USP, ICH and FDA regulatory guidelines. Must be proficient in Microsoft Office and database programs. The position requires the ability to manage multiple projects, meet critical deadlines, and work in a team-oriented environment, yet be self-directed and proactive.

Job Duties:

  • Provides technical support, ensuring quality of all scientific documentation, with a focus on clarity, accuracy and consistency, while adhering to proper format, regulatory requirements and PharmAssist guidelines and processes.
  • Initiates and manages multiple rounds of document review and ensuing revisions, interacting professionally with all levels of reviewers, effectively resolving conflicts and building consensus at each step of the revision process, while ensuring accuracy, consistency and quality of the final document.
  • Critically reviews, interprets and conceptually organizes results from complex submission-supporting study reports, deriving clear, concise and scientifically accurate reported data.
  • May participate in various project activities and meetings related to area of responsibility.

Role Expectations:

  • Excellent communication and presentation skills.
  • Advanced data analysis, trends and reporting skills.
  • Ability to write technical documentation, routine reports, correspondence, procedures and process flows in a manner that presents numerical data clearly and informatively.
  • Exceptional interpersonal skills with ability to convey information and ideas in a variety of media, tactfully and confidently at all levels, internally and externally.
  • Ability to read and interpret documents.

Please submit a cover letter and your resume by email to: 

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  • English (UK)