Why Patients Need You

Pfizer Worldwide Medical and Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary expertise or investigating how to close gaps in data, our mission is simple. Empower healthcare decisions regarding the safe and appropriate use of medicines for patients.

What You Will Achieve

Research Collaborations (RC) are research studies where Pfizer, Inc. partners with an external collaborator(s) to develop, conduct and execute research that would be used to support Pfizer business or regulatory goals. The Research Collaboration (RC) Project Manager provides project management for Pfizer supported RC's to ensure alignment and execution of research, development, and medical strategic and operational goals. The RC project manager (RC-PM) responsibilities encompass strategic planning, oversight, resource management, and risk management of RCs within assigned Therapeutic Area(s). The RC PM will be in support of one or more assets and/or Business/Research Units that engage with external (third party) collaborators that include but are not limited to principal investigators, academic research organizations, cooperative or network, relevant government agencies (e.g., NIH, NCI), other pharmaceutical companies, alliance partners, and any vendors that support CRC activities.

The RC PM needs to have a comprehensive understanding of the governance process, strategic and tactical planning and foundational tools that support the planning, communication, and continuous improvements in operational delivery. Internally, the RC Project Manager is the primary/secondary Point of Contact for Pfizer colleagues, including TA Medical Teams (within the Business Units and Research Units), Field Medical, PCOs, and Regions, Worldwide Research and Development, Pharmaceutical Sciences, Contracts & Outsourcing, Safety & Risk Management, Outcomes Research, Project Management, Legal, Regulatory, and Finance interested in supporting a RC. 

The RC Project Manager also monitors the RC-related systems and educational needs of internal and external stakeholders to maintain compliance with Pfizer’s RC policies and guidelines as well as external healthcare law throughout the process. The RC Project manager will champion operational excellence to provide continuous improvement of processes and sharing of best practices and participates in efforts to improve RC functions globally across an asset program.

How You Will Achieve It

Asset/Program Development, Strategy and Planning for RC

• Offers leadership in planning, risk management, and internal/external communication and stakeholder management strategies.

• Conducts initial review for completeness and classification of RC proposals, entry of information into the RC system, and requests for additional information or documentation through the entire lifecycle of assigned RC studies.

Oversees CRC Due Diligence Activities Internally

• Ensures RC Due diligence activities are completed by the appropriate Functional Line Subject Matter Experts (SME)

• Leads Due Diligence Meetings as needed to provide insights and guidance to team members. 

• Oversees and monitors Due Diligence action items and decision making,

• Facilitates the development of the RC agreement and Quality plans between Pfizer and external collaborator(s).

Project Planning

• In partnership with the Medical/Asset Team, Finance Lead, and Partner Line representatives, accountable for developing and maintaining an integrated program level budget and accurate updated annual forecasts.

• Ensures all lines understand how the RC study fits into the asset strategy, key milestones, and interdependencies.

• Develops timelines, milestone, and risk mitigation strategies

• Ensures appropriate resourcing to support the execution of the RC including Wuhan and RC study manager and to escalate concerns appropriately.

• Monitors RC progress and milestones to ensure on track with projected timelines and to escalate to team if off track

Collaborates with internal and external partners and stakeholders

• Responds to queries from Pfizer and RU/BU ELTs about the status of assigned RC proposals, studies, and RC policies and procedures and other internal and external stakeholders, as required.

• Primary contact with external Collaborator(s), research sites, co-operative groups and public or private sector intergroups and networks globally to facilitate process and execution of RC studies within assigned TA and to ensure compliance with CRC policy, global and local healthcare laws.

RC Execution and Delivery

• Manages Drug and Regulatory strategies for each RC

  • Works with RC Study manager, Wuhan, and Medicinal Sciences colleagues to maintain adequate drug supplies, including pooled supplies when feasible and appropriate.

• Facilitates and monitors the efficient and accurate creation of contracts and amendments for RC studies – new or ongoing – with Legal. Assists with contract negotiations if needed

• Serves as Project Manager for all assigned RCs

• Proactively identifies and manages emerging changes and opportunities; drives iterations of the plans collaboratively with the team to make updates in the project schedule

• Manages study progress reports and results for overall compliance and recommends corrective action or study termination for non-performance.

• Closely monitors progress against goals for operational efficiency ensuring the program delivers on time, within scope, and on budget.

​Monitors RC process and educational needs

• Assists in curriculum development and training in RC operational strategies and compliance regulations

• Adheres to applicable SOPs, written standards, working practices, and implementation guidelines for the RC process, as required and contributes to their development.

• Serves as a trainer/mentor for new RC-PMs, RC Study managers, Medical/Clinical Leads and Functional Lines SMEs on RC policies, procedures, and systems

• Understands and communicates team roles/responsibilities; helps new team members get up to speed on the project and ensures all team members have access to project information necessary to be successful.

• Ensures all appropriate team member views have been raised and incorporated into team decisions as appropriate.

• Participates in task forces to evaluate and continuously improve RC processes and systems, as required, and shares best practices

Qualifications

Must-Have

• 7+ years' experience with bachelor’s degree

• Applicable pharmaceutical industry experience

• Working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations, safety or adverse event reporting

• Demonstrated project management / leadership experience

• Experience with CRO or vender oversight

• Ability to evaluate, interpret and present complex issues and data to support risk

• Excellent communication skills, both written and verbal; must be fluent in English

• Effective decision maker, analytical and solution-oriented

• Demonstrated effectiveness in working in a multidisciplinary, matrix team situation, and demonstrated ability to manage change.

• Experience managing clinical studies in a global environment

• Proficiency in Microsoft Office Suite

Nice-to-Have

• 5+ years of experience with Master's degree, advanced education and/or training/experience preferred

• 3+ years of experience with PhD preferred

• Previous experience training or mentoring colleagues

• Project Management (PMP) certification

• Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Responsibilities may cover multiple time zones and may require both domestic and international travel up to 10%. Occasional attendance at external stakeholder conferences and meetings as necessary. Global virtual meetings require late PM or early AM calls during different time zones.

Other Job Details:

• Last Date to Apply for Job: June 14th, 2023

• Work Location Assignment: Remote.

  Remote colleagues work from home 5 days a week or are field-based colleagues that are not affiliated with a Pfizer site.

The annual base salary for this position ranges from $113,900.00 to $189,700.00. In addition, this position offers an annual bonus with a target of 17.5% of the base salary and eligibility to participate in our share based long term incentive program. Benefits offered include a retirement savings plan, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans. Salary range does not apply to the Tampa, FL location.

Relocation assistance may be available based on business needs and/or eligibility.

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