Manager, R&D Compliance Operations

Employer
Pfizer
Location
Collegeville, Pennsylvania
Posted
Oct 08, 2021
Ref
4821463
Required Education
Bachelors Degree
Position Type
Full time

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.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Travel as needed < 25%

Other Job Details

Eligible for Employee Referral Bonus

#LI-PFE

  

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment.  As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations.  These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure.  Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act.  Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government.  If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.  Pfizer is an E-Verify employer.

Quality Assurance and Control