Manager, R&D Compliance Operations

Employer
Pfizer
Location
New York City, New York
Posted
May 19, 2022
Ref
4852820
Required Education
Bachelors Degree
Position Type
Full time
Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

You will help to shape our reputation and ensure that Pfizer’s R&D colleagues can compliantly share ideas and collaborate with the external scientific community. You will be a member of our R&D Compliance Operations team responsible for supporting compliance and continuous improvement, system management, and colleague support for five (5) key activities to strengthen our internal research pipeline: healthcare professional (HCP) consulting and speaking, HCP travel and meetings, HCP meals, transactions with research/academic organizations, patient engagements, and others as needed

You will support projects and provide guidance to operational teams working across Pfizer’s R&D units and therapeutic areas. You will leverage your strong communication skills to develop core communication materials to support colleague education and awareness. You will illustrate our commitment to excellence by serving as the team’s rapid response expert to issues quickly and compliantly.

How You Will Achieve It
  • 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 develop proactive continuous improvement goals that ensure systems optimally support R&D processes, maintain compliance with applicable policies, and deliver measurable value to Pfizer
  • Develop and execute 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 end-to-end planning and management of mRNA advisory panels where they include external HCP experts, including qualification review, diligence, overseeing contracting, alignment with stakeholders, payment processing, and general HCP relationship management
  • Support other team members on large-scale transformational projects by performing fact finding, business requirement development and documentation, communication with Digital and other teams, change management planning and execution, and tracking/measuring progress
  • 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 compliant management of several transaction types including HCP travel, non-US transactions, and speaker seminars
  • 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
Qualifications

Must-Have
  • Bachelor's Degree
  • 5+ years' related experience in the pharmaceutical industry and/or healthcare compliance operations
  • Experience managing a variety of key initiatives concurrently
  • String writing/editing and verbal communication skills
  • Experience working successfully in a matrix environment
  • Experience working collaboratively to develop and implement continuous improvement projects
Nice-to-Have
  • JD or MBA
  • Experience distilling complex information and communicating clear, actionable recommendations
  • Experience managing vendors to ensure effective project delivery
  • Familiarity with the Pfizer organization

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