Clinical Supply Strategist Senior

25 سبتمبر، 2022

0 39 7 دقائق

الوصف الوظيفي

Position Purpose

This role will be accountable for activities involved in developing and implementing mid to long term Pfizer supply chain strategies and networks for the Middle East, Russia and Africa (MERA) region. This role will support the Global Clinical Supply regional MERA Lead & Global Clinical Supply (GCS) functional groups, including Innovative Sciences Operations (ISO), Clinical Supply Strategy & Management (CSSM), Clinical Research Pharmacy (CRP), Clinical Supply Operations (CSO) and Strategic and Operations Management (SOM), with business growth & execution of new study programs or initiatives that include Investigational Product (IP) forecast, clarification of country requirements, legislations and policies related to IP strategy (including operational timelines and costs), and coordination for key logistics events, monitoring key performance indicators, analyzing cost/performance data, coordinating cross-functional work teams to increase effectiveness of supply chain logistics initiatives.

This position provides high level and strategic support to ISO, CSSM, CRP, CSO and SOM with regards to clinical supplies strategy setup/maintenance, forecast, processes optimization, logistics, import/export processes and global clinical supply requirements. The primary role of the Clinical Supply Strategist Senior is to serve as the primary point of contact between the GCS functional teams and strategic partners and vendors such as Pfizer Country Offices (PCO), brokers, carriers, warehouse, and domestic distribution providers to ensure safe and secure movement of clinical supplies to patients. This role will serve as Clinical Supply Operations’ primary point of contact (POC) for MERA countries.

The position will also support Pfizer Medical Affairs group across the region with regards to Expanded Access, Compassionate Use & Post-Trial Access programs and Bioequivalence/Bioavailability (BE/BA) studies support for IP strategy setup/maintenance, whenever needed.

The role is accountable to Patients and GCS leaders, for delivering GCS Clinical Supply Logistics and Regional Operations activities with regards to planning, cost effectiveness and timely delivery of high quality clinical supplies. The role will proactively ensure quality and compliance through risk identification and mitigation plans, strategic planning and execution, and overall design input on a program and protocol basis.

This position, having a direct reporting relationship to ISO, will ensure compliant and effective IP related activities and projects by interacting with Pfizer GCS Lines (e.g., ISO, CSSM, CRP, CSO, SOM, Quality Assurance [QA]), other strategic Pfizer partner lines (e.g., Global Chemistry Manufacturing Controls [CMC], Worldwide Safety & Regulatory [WSR], Medical Affairs, Corporate Affairs, Pharmacovigilance, Global Product Development [GPD], Pfizer Global Supply [PGS], Finance, Corporate Pricing, Business Units, etc.), and external partners and vendors (e.g., PCO, preferred customs brokers, distribution service providers, carrier service providers and Study Management Partners – Clinical Research Organizations [CRO]), to support strategic clinical supplies initiatives and develop the establishment of regional procedures.

Primary Responsibilities

Serve as the primary point of contact between the GCS organization and strategic partners and vendors to ensure safe and secure movement of clinical supplies to patients in the region.
Lead the development and optimization of import/export processes in MERA.
Ensure compliant and effective import/export activities by interacting with Pfizer GCS Lines, other strategic Pfizer partner lines, and external vendors to drive strategic import/export initiatives and develop the establishment of clear procedures in the region.
Assist the GCS Regional MERA Lead in clinical supplies initiatives and supportive projects in the region (e.g. Expanded Access program strategy, Regional countries setup, MERA Operational Review meeting, Metrics report, etc).
Assist Pfizer Medical Affairs in supplies initiatives and supportive projects in MERA (e.g., Post-Trial Access, Compassionate Use, Expanded Access, BE/BA studies management, etc).
Assist GCS in clinical supplies initiatives and supportive projects in the region, when needed (e.g., Process Mapping & Optimization, Best Practices, Digital Clinical Supply Chain, etc).
Drive local support for Pfizer Regulatory Affairs, GPD and external partners (CRO) in Clinical Trial Application (CTA) by being accountable for reviewing IP related documentations (drug supply description, forecast, manufacture information, etc) for quality and compliance purposes before MoH submission.
Assist Pfizer Regulatory Affairs and/or external partners (CRO) with Import License (IL) umbrella review and validation (drug supply forecast) for quality and compliance purposes, whenever needed.
Drive Regional support for CSO and ISO activities in MERA.
- Ensure that this position is recognized as the Regional Subject Matter Expert (SME) in IP import/export knowledge and expertise with regards to the MERA countries.
- Support the development of strategic initiatives for Pfizer in this region of the world.
  - Duty/VAT savings through special tariff regimes, intelligence gathering and participation in country regulations/changes.
  - Continuous Improvement: evaluate current processes on an on-going basis and make recommendations for continuous improvement with regard to the regional operations and import/export operating model.
  - Process optimization: proactively ensure quality and compliance through risk identification and mitigation plans, by leading and/or identifying strategic and progressive initiatives to support the ISO, CSO and GCS organization.
  - Develop and implement key performance indicators (KPI’s) to monitor operational performance and consistency against stated goals for logistics responsibilities in the countries for this region.
  - Ensure that regional label requirements are established for clinical supplies and comparators.
  - Support the Sourcing Strategy team with regard to the regional requirements.
- Ensure connectivity and awareness to the entry clearance activities conducted by the preferred customs brokers across this regional landscape.
- Participate on the liaison of Pfizer Global Supply (PGS) counterparts in this region to support the development and implementation of strategic initiatives that optimize the logistics process or result in cost savings for Pfizer overall.
Own and advance Pfizer’s Clinical Supply Operations supplier relationships for the MERA Region.
- Manage and enhance the relationship with Pfizer’s preferred customs broker in each of these regional countries.
- Liase with Global Clinical Supply’s GMP Distribution Vendors (e.g., Almac, Fisher, PCI) as well as their country depots to improve logistics operations and resolve any shipment issues that may arise for these regional countries.
- Liase with Pfizer’s preferred Study Management Partners (e.g., ICON, Parexel, Syneos, IQVIA, PPD) and their logistics counterparts to resolve any protocol/program issues that may arise for logistics activities associated with these regional countries.
Drive regional operational support for Pfizer’s Clinical Trial Portfolio.
- Within particular countries: Provide guidance regarding valuation and customs clearance regimes/strategies; Continue to develop strategic relationships with Local Customs and the Ministry of Health (MoH); Continue to develop strong relationships with Customs Brokers and Study Partners to ensure swift and robust import/export activities, Provide guidance and expertise of controlled substance requirements, licensing, cycle times and shipping; and Maintain and enhance appropriate networking relationships with other pharmaceutical companies and trade organizations.
- Within the MERA Region: Provide the support on the above activities but over the landscape of all the MERA countries within scope of this role (i.e., all the regional customs services, MoH, etc.); and Implement the regional strategies that Pfizer is initiating in this landscape with regard to import/export, distribution, packaging and supply chain activities.
- Globally: Contribute to global and cross-functional continuous improvement strategies to improve productivity, cost-savings and exceed customer satisfaction; and Ensure patient satisfaction with all clinical trial activity conducted throughout the globe.
Ensure compliance with all legal requirements (e.g., EHS, cGMP, ICH/GCP, import/export, Quality Standards) by creating and maintaining a culture committed to quality; Accountable for maintaining training and compliance required for the role; Enhance quality and compliance on a site and patient basis utilizing risk and mitigation plans; Contribute to global, cross-functional continuous improvement strategies to improve productivity and exceed customer satisfaction. Assess cross functional impact of procedure/ process changes to ISO, CSSM, CRP, SOM and CSO processes.

Technical Skill Requirements:

Must include:

Demonstrated experience of coordinating and measuring work, negotiation, conflict management, influencing, process improvement, project management.
Demonstrated ability to coordinate complex projects and processes; MS Office suite advanced proficiency, in particular, Excel.
Have fluency in the English Language as well as hiring country language (Arabic and/or Turkish), French language will be an advantage.

Must include some of the following:

Drug development process.
Pharmaceutical manufacturing /packaging & labeling.
International logistics and associated regulatory requirements.
cGxP requirements, Quality Assurance/ Compliance activities.
Inventory Management and Distribution Systems including Interactive Response Technology (IVRS/ IRT).
Knowledgeable or proficient in data analytics tools such as Business Objects and possess the ability to translate a business need into supporting data with speed and accuracy.
Knowledge of Interdependencies of principles, practices and concepts of supply chain and relevant business disciplines.

Accountable to the Clincial Supply Team (CST) for assistance with regional operations and logistics related to process management, budgeting questions and must demonstrate fiscal responsibility in managing logistics expenses.

100% part of GCS Innovative Sciences Operations (ISO).

It is not envisioned that this role will supervise direct reports, but workload requirements could demand supporting contracted resources.

Role requires a Pfizer site presence in hiring location.

Ability to travel (domestic and international) up to 15% of the time; must be able to drive and/or fly to vendor locations with advance notice and/ or attend job related training as required.

Qualifications

Training & Education Required:

Bachelor of Science degree (or equivalent) is required, with 5 years minimum of relevant experience (preferably in the pharmaceutical industries).
Must be proficient in Microsoft Office programs including SharePoint.
Demonstrate interest in Patient Quality and Compliance.
Ability to speak major languages (English and Arabic and or Turkish/French) in the region to communicate with local authorities and read local documents related to clinical supplies (e.g. Importation, labels, package, etc).
Advanced English language is required.

Prior Experience Desirable:

Work experience must include some of the following: drug development, clinical study design including randomization, scientific research, pharmaceutical manufacturing/ packaging/ labeling, sourcing, vendor management, distribution, supply chain management, cGMP requirements, supporting project teams.
Project Management certification is desirable. Training in project management, supply chain management, scientific or clinical disciplines, clinical sites, comparative agents and/or business administration are desirable.
Demonstrate skills with technical, planning, analytical and financial disciplines.
Manage risk and uncertainty. Demonstrate good decision-making on sound mix of analysis and judgment.
Demonstrate ability to support complex projects and processes.
Achieve results through influence in a matrix organization.
Demonstrate ability to align personal objectives with the goals of the organization.

Experienced Colleagues would be expected to have:

Prior experience with development & implementation support of strategic plans in research and development operations within the pharmaceutical industry as well as a solid understanding of interdependencies of supply chain and logistical processes.
Prior experience with the import/export regulations of MERA which may include focused expertise with Local Customs and with the MoH. Prior experience with the import/export requirements of country of hiring is mandatory.
Knowledge of the import/export regulations and logistics associated with the Customs Services, MoH’s and Other Government Agencies for the other regional countries within scope of this role.
Commits to “One Pfizer” and our Bold move organization imperatives.
Strong communication and presentation skills.
Strong experience in high level analysis, building strategies and innovation of project execution.
Ability to lead with and without direct influence high performing teams while maintaining highest integrity.
Acts decisively in complex and fast-moving environment.
Demonstrable capabilities to manage or work within a matrix organization.
Demonstrable experience across function and across category experience at country/countries level.
Strong collaborator within and outside the MERA region.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Research and Development
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