Early Development Operations

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Early Development Operations

Cambridge, Massachusetts

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Full Time

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$ 55 - $ 65 per hour

Cambridge, Massachusetts

Full Time

$ 55 - $ 65 per hour

May 29, 2024

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Job ID: LD_Early Develop Ops_1717010474

May 29, 2024

Job ID: LD_Early Develop Ops_1717010474

Job Summary

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Beacon Hill Life Sciences is actively recruiting for a contractor to support Early Development Operations (mainly non-clinical) within pharmacology, toxicology, DMPK and bioanalytical.

This is a fully remote contract assignment.
Duration is 12 months, with potential of hire in 2025 however this is not a guarantee.
Pay is based on experience with range between $55-$65/hour (paid weekly).

Contractor will work collaboratively with scientists within Early Development (pharmacology, toxicology, DMPK and bioanalytical) and with internal cross-functional partners (CMC, Analytical Development, Genomic Operations) to support the management of internal and outsourced studies, as needed including working with CROs.

Responsibilities include:

  • Support statement of work (SOW) generation, study contracting and invoicing processes for nonclinical and clinical studies
  • Assist in reconciliation of invoices against billed work for clinical and nonclinical activities for accuracy
  • Support phase 3 program logistics in preparation for market approval
  • Keep internal tracking systems up to date as they relate to individual project/program needs or regulatory filings
  • Perform quality control (QC) data review/verification on internally and externally generated protocols, amendments, reports, and other nonclinical materials/documents
  • Nonclinical document generation and document management to support projects/programs and regulatory submissions
  • Facilitate review and approval workflows of internally generated scientific reports
  • Support the completion of documents and other assigned tasks within established timelines and with high quality in terms of organization, clarity, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes
  • Contribute to the development of new tracking systems, new processes, process improvement initiatives and standards, promoting ideas for optimization
  • Contribute to development of database to track control and reference samples ensuring stock is accurate (e.g., using LIMS)
  • Provide support for sample logistics and documentation, collaborating with cross-functional groups to ensure testing can run uninterrupted, as needed
  • Support Clinical Operations and eDev in managing shipments from central labs to CROs and assist in resolution of discrepancies
  • Assists in coordination of sample logistic workflow throughout the department to ensure turnaround times are met

Requirements include:

  • BS/MS or equivalent in a STEM field is required
  • 3+ years of nonclinical/clinical experience (mainly nonclinical) in the pharmaceutical industry with a proven track record of supporting multiple projects, priorities, and nonclinical studies collaborating in multidisciplinary environment
  • Experience supporting clinical and nonclinical sample management
  • QA/regulatory submissions experience
  • Scientific operations oversight
  • Familiarity with Good Laboratory Practices (GLP) and IACUC policies.
  • Must have experience collaborating with external parties/contract research organizations (CROs).
  • Must be enthusiastic, detail-oriented and have ability to multi-task (must be able to support multiple projects)
  • Proficiency with Microsoft suite; Smartsheet, Share Point, Veeva a plus

LD_Early Develop Ops_1717010474

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About Beacon Hill

Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.

Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.

Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.

We look forward to working with you.

Beacon Hill. Employing the Future™