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Senior Manager, Clinical Supply, 100% REMOTE

Job Attributes

Job Id:

20021

Job Category:

Clinical & Life Sciences

Job Location:

San Francisco, CA  94016

Security Clearance:

No Clearance

Business Unit:

Piper Companies

JOB DESCRIPTION

Piper Life Sciences is currently looking for a Senior Manager, Clinical Supply in to work 100% REMOTE for an industry leading Biotechnology organization working in support of the Clinical Group.

Responsibilities for the Senior Manager, Clinical Supply include:

  • Selection and management of contract packaging and distribution organizations
  • Management of activities related to clinical packaging, including: labeling, delivery, reconciliation, and destruction of clinical supply materials
  • Design and/or review label text to meet product requirements and ensure compliance with US and international regulations
  • Work with formulation and fill finish groups to ensure the requirements of the product are met during packaging and distribution of the material
  • Partner with Quality Assurance and Regulatory Affairs to ensure investigational product meet US and ex-US requirements and can support
  • Accountable for effectively managing clinical supplies based on study timing and in accordance with clinical protocols, cGMP, GCP, ICH, FDA, and other applicable international, federal, and/or local regulations
  • Maintain active inventory of clinical material and supplies and coordinate the supply of the materials from manufacturer to clinical sites or depots
  • Work with Clinical Operations to understand investigational drug supply requirements for current and future trials. Coordinate with Technical Operations to ensure drug manufacturing and release timelines will meet clinical study timing and requirements
  • Ensure domestic and global distribution requirements are in place with external partners to allow for shipment of investigational product. Review and track documentation required for submission to the US and ex-US regulatory authorities. Support regulatory submissions
  • Perform clinical site, depot, or CMO audits and/or technical visits as required
  • Perform risk assessment and elaborate contingency
  • Participate on project teams and provide clinical supply updates; communicate plan and timelines to internal and external customers and partners
  • Utilize appropriate software and IT systems to effectively manage key project activities. Oversee implementation of key supply management software, e.g. IRT

 

Requirements for the Senior Manager, Clinical Supply include:

  • 4+ years of experience in clinical supply management
  • Demonstrated experience with clinical supply management planning, labeling, packaging, and distribution
  • Clinical Supply management experience using contract manufacturing companies strongly preferred
  • Knowledge of GMP batch record development, review, and approval processes. Knowledge of Interactive Voice/Web response systems for use in clinical studies
  • Working knowledge of regulations relating to clinical labeling, packaging and distribution activities
  • Working knowledge of GMP/GCP/GLP regulations required
  • BS/BA degree in related discipline with at least 7

 

Compensation for the Senior Manager, Clinical Supply Includes:

  • Salary up to $120k dependent on qualifications and experience
  • Full Benefits Including: Health, Vision, Dental, 401k plan

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New Search

Job Id:

20021

Job Category:

Clinical & Life Sciences

Job Location:

San Francisco, CA  94016

Security Clearance:

No Clearance

Business Unit:

Piper Companies