RoleDistribution / Logistics Advisor
Duration: 12 months
Location: Cambridge 3 days per week on site.
Rates: Inside IR35- 18 - 20 per hour PAYE/ UMB
We are looking for a Distribution/ Logistics Advisor for a 12 month contract for a very large Pharmaceutical giant who are based in Cambridge. Please see below job details:
- Plan and manage Drug Substance (DS), Drug Product (DP), and Investigational Medicinal Product (IMP) distribution & returns for assigned clinical studies.Includes detailed planning and active management of complex distribution scenarios where necessary to ensure accurate on-time delivery both within local territories and across international borders
- Work collaboratively within Logistics and Clinical Supply (LCS), with external vendors, and with all other interfaces and stakeholders as required to ensure highly effective clinical product distribution
- Develop import/export intelligence and collation of territory specific distribution learnings for LCS
- Contribute to the operational effectiveness of LCS
Major Duties and Responsibilities
- Plan and manage DS, DP and IMP distribution, returns and destruction activities for assigned Development Projects both domestic and international
- Deliver shipping options and recommendation for DP, IMP and Auxiliary Medicinal Products (AMPs)
- Select and manage distribution vendors in conjunction with Technical Manager and internal stakeholders
- Provide clear and up-to-date information to distribution vendors in relation to assigned projects, reviewing all transfer requests for accuracy and completeness prior to processing
- Ensure timely maintenance of current, accurate and complete IMP distribution records (hard copy and electronic as appropriate) in line with GMP and GCP requirements.
- Coordinate and document activities related to the production of distribution, returns and destruction documentation, and all other related documentation used by the shipping vendor or clinical site.Includes activities to enable provision and maintenance of necessary import/export documents and permits (e.g. pro-forma invoice, import license)
- Maintain oversight of the IMP returns process (including stock recovery) to aid in documenting full IMP reconciliation
- As required coordinate distribution activities in relation to DS and/or QC sample shipments aligned to assigned projects or specified manufacturing facilities.
- Support timely maintenance of current, accurate and complete IMP Distribution records, ensuring that necessary information is filed to all relevant GXP repositories including Product Specification File (PSF) and Trial Master File (TMF)
Collaborate effectively within LCS to provide successful on-time delivery of quality DS, DP, IMP and AMP to assigned projects.
Maintain & expand close cross-functional relationships in order to best effect provision of appropriate systems (e.g. support to IXRS User Acceptance Testing), and distribution of clinical supply materials for assigned projects
Liaise closely with Quality Assurance (QA) to coordinate activities such as shipper qualification, cold-chain demonstration and all activities expected in accordance with cGMP, GDP, GCP, & ICH guidelines
Partner with stakeholder departments to ensure that any issues relating to DS, DP or IMP distribution (such as complaints, excursion investigations, or deviations received from sites or shipping vendors) are highlighted and options/recommendation are developed quickly for resolution
Initiate non-conformances when identified and complete investigations to support on-time closure of deviation records
Monitor, process, and issue dispositions of transit and storage temperature excursions according to established procedures. Provide excursion logs to internal stakeholder departments for review as required.
For assigned projects, champion and represent distribution activities in LCS Matrix and other project meetings as required.Otherwise support the LCS Study Manager by contribution to overall supply planning, distribution strategy and effective use of distribution systems for stakeholder reporting etc.
Assist in the review and preparation, of departmental SOPs, processes and systems to support maintenance, improvement and future growth of Distribution best practice.
- Contribute to development of LCS clinical supply import/export intelligence, providing input to format of templates / information repository, and enabling efficient input, update and retrieval of data
- Collaborate in the creation and maintenance of a territory manual, including project learnings and experience as relates to IMP distribution across international borders
- Attend and actively participate in departmental meetings
- Participate where required in LCS departmental and/or assigned cross-functional process improvement initiatives
- Apply own training and expertise to effectively fill and deliver against flexible assignments within other aligned LCS roles as required
- Mentor other members of staff (members of LCS, summer interns, rotational associates, etc.) assigned to flexible roles within the Distribution team, and provide back-up support to other staff members as required
- Communicate effectively with assigned teams, BPD, and with all interfacing functions and relevant groups as required
- Agency: Cpl Life Sciences
- Reference: JO-2206-495158
Website: Cpl Life Sciences
- Posted: 21st June 2022
- Expires: 19th July 2022