Clinical Supply Planner...

Job Description Clinical Supply Planner Essential
Pharma are looking for a Clinical Supply Planner to join us! This
role will include determining packaging, labelling requirements for
clinical trial supplies, inventory control of distributed clinical
trials supplies in line with clinical demand at sites, cold chain
storage at local warehouses and clinical trial sites according to
GCP and worldwide distribution requirements for export/import of
the study drugs being trialed. Strict compliance with national and
international regulation and manufacturing practices (GCP/ GDP) and
appreciation of GMP standards is essential at all stages of the
supply chain to meet the clinical demand. Apply today! What You
Will Do - Provide and manage the clinical demand to manufacturing
project management based on clinical development plan to allow
manufacturing sourcing and lead times. - Work closely with the
clinical manager to establish the needs for the IMP as per study
protocol and territories. - Collaborate with the manufacturing
Development Project Manager for the clinical demand from
forecasting according to recruitment strategies to delivery of
supplies to clinical sites through coordination of resources,
managing risk progressively throughout the life cycle of the
project. - Drive the project schedule and associated deliverables
by working with internal/external stakeholders in clinical
development i.e. Project managers for clinical and manufacturing
development. - Liaising with both managers to marry up the need for
labelled and packaged supplies available and the demand at the
sites/ territories to avoid stock outs in ongoing trials - Serve as
the primary point of contact and initial escalation point for all
internal/external project challenges related to clinical trials
supplies at sites/ territories. - Hold full responsibility for the
timely delivery of projects through successful coordination of all
tasks associated with company deliverables. - Assess scope, timing
and operational requirements of the project - Key contact for
establishing site by site destruction/ returns strategies for the
trial and ensure documented. - Ensure documentation for supplies
are filed appropriately as Essential Records according to GCP/ TMF
planning etc. - Maintain inventory of IMP - Facilitate transfers
from site to site as needs be and oversee the shipments. - Ensure
essential records in place following regulatory green light and are
applicable for the territories and the clinical trial protocol. -
Notify the Manufacturing PM of any deviations affecting product
quality and provide appropriate supportive documentation to allow a
review and facilitate any product recall/ quarantine etc. -
Contribute to SOP compilation relating to clinical demand at site.

• Create and implement Standard Operating Procedures (SOPs) for all
  aspects of the clinical trial demand. - Contribute/ drive to the
  distribution plan/ labelling text/ translations to enable
  manufacturing PM to plan the GMP production of labelled and
  packaged supplies manufacturing. - Establish clear communication
  pathways to define roles and responsibilities, and to ensure
  accurate and timely exchange of information to support development
  of supply chain strategies, including forecasting in respect to
  clinical recruitment and according to the study protocol. -
  Critically evaluate available information and provide advice to
  create a robust and flexible supply chain strategy that ensures
  drug availability but also minimizes waste at sites. - Ensure a
  valid Technical Agreement (TA) is in place to document standard
  working practices and define responsibilities, as applicable. -
  Lead the coordination of activities of other company business units
  involved in the project, where applicable, ensuring expectations
  are understood by all parties. Work with third parties involved in
  projects such as CROs and/or consultants. - Ensure the optimal set
  up and ongoing maintenance of the Interactive Response Technology
  (IRT) System in support of medication management, where contracted
  and as applicable. - Oversee the clinical demand to lead planning
  for clinical trial supplies (in line with study protocol) and
  distribution plans. Maintain forecasts on an ongoing basis,
  adapting strategies as required to minimize product wastage and
  assure site supply needs are met. - Prioritise, troubleshoot and
  assist with identifying and solving clinical supply issues. Monitor
  inventory levels of product at all depots and clinical sites. -
  Perform risk assessment at project initiation and continually
  assess throughout the project. Work together with the project team
  and internal departments to prioritize and mitigate any project
  risks identified. - Monitor budgets, ensuring projects are
  proceeding in line with approved quotations for distribution to the
  clinical sites. - Ensure any trends in quality issues reported are
  identified and actioned accordingly to the project team and acted
  upon via CAPA - Monitor and advise upon receipt of product related
  temperature excursions both in-transit and at sites in a timely
  manner and ensure communicated to PM Manufacturing Dev What We Do
  Essential Pharma is an international specialty pharmaceutical
  company dedicated to maintaining access to clinically
  differentiated, niche medicines in small patient populations. Our
  high-impact portfolio includes over 300 medicines covering ten
  therapeutic areas, with a focus on the central nervous system
  (CNS), gastroenterology, ophthalmology, and rare diseases. Our
  products treat patients in more than 70 countries. We are proactive
  in identifying low volume, difficult-to-manufacture therapeutic
  products, and late-stage clinical development assets that target
  rare diseases. Our recent acquisition of Renaissance
  Pharmaceuticals is a significant milestone for Essential Pharma,
  the groups second product for treatment of a rare disease, and the
  first development-stage asset in our portfolio. In December 2024,
  Essential Pharma announced a €900 million recapitalisation with
  partners Gyrus Capital, welcoming AlpInvest and new strategic
  financing from Sixth Street. Our business is comprised of around 70
  people based out of our offices in Surrey UK, Malta, France, Spain
  and Switzerland. What You Will Bring - Significant in a
  pharmaceutical industry in a Supply Chain function, preferably with
  significant exposure to clinical trials and supplies. - Experience
  in previous clinical trials with multi-territories and multi-sites
  is a requirement as well as involved in label design for
  multi-language countries and subject kit design. Additional
  experience in sourcing and supply of non-IMPs and ancillaries to
  support a trial. - High level understanding of critical GXP, GCP
  project documentation and their relevance to the project plan and
  ensure are filed correctly in accordance with the established
  project filing i.e. TMF etc. - Experience of working with ERP
  systems. - Evidence of effective communication and stakeholder
  management. - GDP, GCP and GMP proficiency. What We Offer -
  Competitive Salary - Hybrid Working: We offer flexibility and trust
  from day one, with a balance of remote and office-based work. We
  understand that different roles have different requirements and are
  committed to providing additional flexibility as needed. This will
  be discussed during the initial interview process. - £150 towards
  your home office – claim purchases back on expenses. - Healthcare
  Insurance - Pension – you contribute 5% and we offer 5%. - Life
  Insurance – lump sum (tax free) death benefit of 4 x basic salary.
  
• Enhanced Family Leave - Enhanced Sick Pay - Annual Leave – 26
  days - Discretionary Annual Performance Bonus What To Expect - We
  wholeheartedly embrace agile and hybrid working, recognizing that
  it enables individuals to bring their authentic selves to work. Our
  commitment to living by our values forms the bedrock of our
  inclusive culture, where everyone's voice is valued and respected.
  
• Treating each other as adults fosters a sense of autonomy and
  responsibility, while our inherent social nature is nurtured
  through engaging groups and events. We understand the significance
  of forging connections in the workplace, and our dedication to
  facilitating these bonds is underscored by regular access to our
  CEO. Grounded in the principles of dynamism, responsibility,
  trustworthiness, and collaboration, our values guide our
  interactions. Furthermore, our unwavering dedication to employee
  growth and learning is evident through our commitment to
  personalized development plans, as we believe in fostering an
  environment where all individuals can thrive. - Right from the
  interview stage, we encourage candidates to ask us questions, as we
  understand that it's just as important for us to be the right fit
  for you as it is for you to be the right fit for us.