Job Opportunities at Pfizer

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 experience in Clinical supply Management or Clinical research and/or Supply Chain (preferably in the pharmaceutical industries).
• Must be proficient in Microsoft Office programs including SharePoint.
• Demonstrate interest in Patient Quality and Compliance.
• Ability to speak other languages is preferable to be able to communicate with local authorities and read local documents related to clinical supplies (e.g. Importation, labels, package, etc.).

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.

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POSITION SUMMARY

The  Senior Medical Manager Vaccines  is responsible for developing and executing the medical plan that supports the strategic operating goals for the vaccines business, supports cross-functional projects, and is accountable for his/her medical and scientific initiatives related to the vaccines products. To develop strategic partnerships with key external stakeholders during the entire life cycle of Pfizer products, providing focused relevant information in response to customer-stated needs in order to maintain a therapeutic leadership position and drive business needs at the national, regional & corporate levels.

POSITION RESPONSIBILITIES

• Develop and execute a medical strategy that supports the country operating plans with a specific focus on driving business growth through medical insights
• Provide country perspective for the Vaccines assets at Vaccines reviews and planning (together with country Commercial/marketing, Regulatory Affairs, and Legal functions)
• Medical input  into assigned brand cross functional team and where necessary into local Customer based marketing initiatives
• To interact with and develop enduring relationships with national opinion leaders, national advisors on clinical practice, contributors to national guidelines and management protocols
• To communicate customer feedback on product development and life-cycle strategies
• Dissemination of recent scientific knowledge/data on Vaccines portfolio in approved indications
• Communication of recent scientific knowledge/data on Vaccines portfolio in off-label indications and on Vaccines products in development upon request
• To provide quality scientific presentations at internal and external meetings
• Soliciting feedback on clinical trial programs and protocols (feasibility) from potential investigators for Vaccines portfolio
• Management of IIRs-presentation of proposal, internal scientific review, & conduct follow up
• Conception, management and implementation of  observational (Non Interventional) studies
• Collaborate with Vaccines medical teams to support development of a strategic regional/country publication plans.
• Medical lead for local/national advisory boards: - Advisory Boards conduct to gather expert guidance to advise medical planning.  - Provide input into regional Advisory Board planning, support implementation and presentations (as needed).
• Conduct of medical to Medical Local medical education activities
• Medical support for formulary applications when needed
• Provide country Vaccines medical leadership, support and guidance for label updates and responses to regulatory requests when needed.
• Provide country medical support, analysis, and guidance for drug safety updates or issues pertaining to Vaccines portfolio.
• Deal with customer enquiries on drug safety issues for Vaccines portfolio
• Medical societies identification and collaboration relevant to Vaccines BU
• Medical support for other customer facing teams, including medical training
• Provides a critical review and medical input into promotional materials and marketing strategy.
• Partner with legal, regulatory and marketing colleagues to ensure compliant, accurate and high quality content of all promotional and training materials

EDUCATION AND EXPERIENCE

• Medical doctor (MBChB or MD) is a minimum requirement .
• At least 3 years Pharmaceutical Medical Affairs experience (Vaccines Background Preferred).

TECHNICAL SKILLS REQUIREMENTS

Technical skills required and/or preferred, as applicable.

• An appropriate Vaccines therapeutic knowledge is preferred as well as an understanding of the therapeutic context and of the products in the portfolio
• A good understanding of clinical research as well as the ability to critically evaluate clinical studies whether a protocol or a publication
• An understanding of the national and regional health environment including its structure, policy, key members and scientific societies
• An understanding of the process of drug development
• Knowledge of the relevant and applicable Codes of Practice, SOPs, regulations and guidelines as they apply to the function.
• Knowledge of pharmacovigilance and regulatory legislation and how it impacts the product portfolio
• Strong business acumen- Knows the industry; knowledgeable in current and possible future trends, technology, and information affecting his/her business and organization; knows the competition; is aware of how strategies and tactics work in the marketplace.
• HCP focus- Is dedicated to meeting the expectations and requirements of internal and external customer’s products and services; always focused on patient safety first, establishes and maintains effective relationships with customers
• Organization alignment- Is aligned with the culture, values and mission; operates with the mission and values in mind; encourages others to act in a manner aligned with organizational culture, values and mission.
• Results driven- Can be counted on to exceed goals successfully; steadfastly pushes self and others for results.

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ROLE SUMMARY

Pfizer's Financial Services organization delivers best-in-class accounting, finance and compliance operations globally for the Pfizer enterprise. This organization is a high performing team comprised of more than 1600 colleagues primarily located in 6  hubs around the world, in addition to an outsourced workforce of 350 people. The industry-leading value proposition is to centralize, standardize and optimize complex processes and in delivering a quality service at a reasonable cost with a compliance mindset.  The scope of services provided include Record to Report processes: US Accounting, Corporate Accounting, Statutory Reporting, Financial Reporting, Intercompany, Financial Master Data Governance, Risk Management & Compliance, Capital, Inventory, Lease and Balance Sheet; Transaction Processing in Invoice to Pay, Indirect Tax, Order to Cash, Credit Risk and Gross to Net; Operational Transfer Pricing; GFS Treasury Operations, and MAPP Administration.

The Compliance, Controls, and Risk (CCR) Lead will be responsible for providing risk, compliance and control guidance around compliance quality monitoring activities, remediation plans, and reporting. The CCR Lead will support a cluster of markets and assignments will be based on market size and risk indicators. The current in-scope areas for CCR function are Internal Controls Over Financial Reporting (ICOFR), Sarbanes-Oxley Act (SOX), Foreign Corrupt Practices Act (FCPA), and Healthcare compliance.

ROLE RESPONSIBILITIES

• For assigned markets, develop and maintain a strong and practical risk awareness, compliance and control culture and environment through partnership with Market Operations Lead, Business Finance and Market Compliance Lead
• For assigned markets, provide leadership, guidance, and consultation in collaboration with Market Operations Leads, Business Process Owners, Compliance and Legal to:
• Ensure process and internal control changes resulting from new or changing Corporate Financial Reporting Policies and Procedures and Corporate/ Divisional FCPA Policies and Procedures are documented in standard operating procedures (SOPs) and/or Work Instructions (WI)
• Provide expert support, oversight and implementation of required changes resulting from control remediation or business process, technology or control changes. Ensure local business processes and/or technology changes are evaluated and communicated as needed. 
• Streamline and harmonize local policies, including removal of local/ divisional policies where they can be leveraged from Corporate Policies and Procedures or Global SOPs
• Provide local consultation on Global Policies as directed by RM&C, Compliance and any other Global Policy owners to ensure consistent interpretation and processes in all markets
• Provide guidance and expertise to business process owners in the development, execution, and documentation of remedial actions for deficiencies in ICOFR/ SOX or FCPA design or operating effectiveness or process enhancements identified through day-to-day compliance and control activities or Corporate Audits
• Review of the SOC 1 reports (or equivalent) to assess exceptions (gap analysis) upon market request. Assess that all exceptions have been evaluated and that significant issues have been followed-up
• Monitor the design and effectiveness of remediation activity and report on its progress to market and region stakeholders (Finance, Commercial, Compliance, Legal, GBS as applicable)
• Designing, execution and reporting of focus-based reviews for a region Execute analytical reviews used to identify and investigate red flags in the areas of ICOFR, FCPA/HCC (Healthcare Compliance), , which may include the identification of Key Risk Indicators ("KRIs”); ensure resolution of all items identified
• For assigned markets, lead the coordination and preparation of the audit process in collaboration with CCR Sr Analyst(s), by serving as the main point of contact with the / internal auditors for scheduling and logistics; communicate the list of requirements to Market Operations Leads, Regional Colleagues, and BPOs and inform them of any non-compliance
• Report results of healthcare compliance initiatives activities using guidance, tools, and templates provided by RM&C leadership, which will also be presented to local and regional management
• Execute escalation protocols designed by Controllers and Financial Services Leadership for deficiencies or issues identified as a result of monitoring initiatives or as escalated from BPOs
• Partner with Controllers and other key stakeholders (e.g. Compliance, Legal, Divisional Controllers) to develop periodic training materials related to ICOFR/ SOX, or healthcare Compliance related as needed
• Deliver periodic training in the market on ICOFR/ SOX and FCPA upon request
• Organize and handle training sessions to the CCR Sr Analyst(s) on the local procedures and practices
• Lead and execute global and regional compliance and control projects as appropriate
• Mitigate key risks affecting the market identified as a result of the leadership risk assessment
• Lead and execute other in-market activities and compliance work as appropriate
• Participate in the Market Risk Management Forums (mRMF) and the Market Quality Compliance Committee (mQCC) upon invitation. Provide subject matter expertise on internal processes and alignment of these processes in dispute areas
• Attend training as required 

BASIC QUALIFICATIONS

Education and Experience:

• Approximately 5 – 8 years of working experience in a risk management/ control environment, including experience with risk identification, measurement and assessment, risk monitoring, reporting and escalation
• Bachelor’s degree from an accredited college or university; MBA / CPA preferred or other equivalent education / certification (e.g., Chartered Accountant)
• Experience working in a Risk Assurance Manager, Controller, Compliance and/ or Audit role
• Experience in ICOFR, SOX, FCPA
• Experience navigating a large, complex organization and managing stakeholder’s interests using a matrixed organization
• Strong project management skills
• Experience influencing and executing complex solutions involving multiple groups
• Experience in developing and executing training at all levels of the organization
• Excellent analytical skills with a demonstrated ability in risk identification, measurement and assessment, risk monitoring, reporting and escalation
• Ability to work in a fast-paced and demanding environment
• Strong organization and planning skills
• Ability to communicate well within all levels of Pfizer
• Ability to identify business issues/ opportunities and to frame business questions
• Ability to interact with business and finance leaders across Pfizer Inc.
• Ability to communicate effectively with the Pfizer compliance community, and share information in an open and transparent way
• Ability to facilitate and lead knowledge sharing and training sessions with process owners as a means of harmonizing processes and controls
• Savvy with industry and Pfizer financial systems and financial reporting processes
• Demonstrate courage, excellence, equity and joy and embody our values and behaviors