NEUROVUE is disrupting the Life Sciences consulting paradigm with a proprietary approach to talent attraction and retention. With focus and extensive investment, NEUROVUE has created an unparalleled employment experience that attracts industry top minds for our clients’ project needs. Through this innovative approach, clients rely upon NEUROVUE for project-based precision and execution.

Our industry demands a firm that continuously develops and provides top talent focused on achieving complex project goals. NEUROVUE is the complete and trusted solution to these specialized talent needs.

NEUROVUE is seeking advanced degree life-sciences professional to serve as a Medical Writer within our Medical Strategy and Communications team, which serves our clients by mobilizing our scientific knowledge to interpret the data and create compelling narratives to guide their medical strategy and through regulatory challenges.

RESPONSIBILITIES

• This role must have a good understanding of Quality Control and apply practical knowledge of phase appropriate GMPs and regulatory requirements in the product development life cycle, including but not limited to: Lot release; Method qualification and validation, Technology Transfers, and writing/review of QC procedures
• Performs review and approval of CMO/CTL OOS investigations, deviations and other quality events
• Conducts routine and non-routine chemistry and microbiological analysis of raw materials, in-process formulations and final products to established specifications.
• Operate at a consistent and exemplary level of efficiency, producing high quality and accurate documents
• Due to the nature of testing schedules, must be willing to work weekends, evenings, and holidays, as needed
• Utilized and operates laboratory equipment and instruments according to laboratory work instruction or laboratory procedures such as pH, conductivity, UV, KF, FTIR and titrations.
• Ability to understand and follow Quality Control test methods or compendia methods (USP, EP, BP, JP or ACS) and EXCIPACT standard.
• Performs technical review of lab data forms such as water, environmental monitoring and direct measure analysis.
• Enters final results and raw data for tested materials or products in LIMS (Laboratory Information Management System) as needed.
• May perform investigative analysis to support investigations, complaints or instrument troubleshooting.
• Performs Environmental Monitoring duties, which requires gowning into cleanroom and collection of air and surface samples while in the cleanrooms.
• Reviews for discrepancies in data, manufacture COA, COC, and performs data verification in accordance with company procedures.
• Applies appropriate disposition labels to materials (accepted, rejected, etc).
• Handles hazardous materials using all appropriate or mandatory safety PPE and safety equipment.
• Completes documentation in a legible manner and reviews for accuracy.
• Performs other duties as assigned.

QUALIFICATIONS

• Bachelors degree in a science discipline with knowledge and experience in one of the following areas: Chemistry, Biology, or Microbiology
• 1-3 years of laboratory experience in related field
• Wet chemistry experience preferred (ex. Acid/Base Titrations, water content)