Job Description

ROLE SUMMARY

The purpose of this role is to manage and support multiple aspects of the operational infrastructure that helps R&D colleagues compliantly develop scientific and technical content for external communication and also to avoid potential conflicts of interest when participating in external activities outside of Pfizer. The individual in this role must have an understanding of healthcare compliance and continuous improvement principles, as they provide compliance review, system management, and serve as the team’s rapid response expert to address process questions or issues from across Pfizer’s R&D units. This role is responsible for issue tracking and risk analysis, including transactional monitoring, to inform and pull through enhancement opportunities and quality improvements in the areas of non-clinical content and potential employee conflicts of interest (COI). Additional responsibilities include ongoing assessment and identification of external environment trends/best practices as well as activity reporting across Pfizer’s R&D units.  Further, the individual in this role must have excellent project management and communication skills, as they are responsible for providing oversight of designated vendors on system support projects and will oversee the development of core communication and/or colleague training materials. Individual project work to meet the team’s semester-based goals, as well as project management, budget tracking, and other project support, will also be required.

ROLE RESPONSIBILITIES

Manage relevant healthcare compliance processes, requirements, and systems to establish best practice and support R&D colleague compliance with Pfizer policy and applicable laws and regulations

Analyze trends and transactional data to ensure systems optimally support R&D processes and maintain compliance with applicable policies

Identify external environment best practices to develop proactive continuous improvement goals that deliver measurable value to Pfizer

Develop an informed and effective communication and training plan to educate R&D colleagues on healthcare compliance processes, compliance requirements, and support provided by R&D Compliance Operations, including drafting and development of communication and training materials

Provide timely, actionable guidance and client support as process subject matter expert (SME) to address process questions from users and to develop materials to support issues management

Assist with the development and ongoing maintenance of SOPs, work instructions, and auditable documents and create work instructions to maintain a consistent and efficient operational model

Provide project management oversight of designated vendors on system design projects and other enhancement projects or initiatives

Conduct transactional monitoring and report on all remedial or corrective actions to identify trends and to drive continual improvement

Work across R&D units/partner lines and country stakeholders to share best practices

Basic Qualifications

5-7 years of applicable experience in pharmaceutical healthcare compliance and/or compliance operations functions

Bachelor’s degree

Demonstrated ability to adapt in a dynamic and fast-paced environment; nimbly shifts priorities as necessary to meet business needs

Excellent organization skills and proven track record in managing complex projects with multiple stakeholders; must be detail-oriented

Demonstrated success distilling complex information and communicating clear, actionable recommendations

Demonstrated ability to manage vendors to ensure effective project delivery

Excellent written and verbal communication skills, including interpersonal skills and conflict resolution

Ability to work within a matrixed global organization and develop a strong, effective network of colleagues

Preferred Qualifications

JD or MBA

Pharmaceutical industry experience and familiarity with the Pfizer organization.