Manager Controlled Substance Distribution

Why Patients Need You

We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines.

What You Will Achieve

Manager, Controlled Substance Distribution is the primary point of contact for management and Coordination of the Pfizer Fundamentals for U.S. Logistics Compliance in the following areas:

• Provide support for Controlled Substance Compliance, specific to DEA Regulations for Memphis Logistics Center and back up support for all other sites.
  
• Center - Licenses backup support for plants & Logistics Centers. Support site correspondence with state agencies.
  
• Primary point of contact for DEA and internal audits of controlled substance activities.
  

Continued compliance with controlled substance and state regulations is critical in ensuring Pfizer can consistently produce and distribute controlled substances and other prescription products. Failure to effectively support the manufacturing and commercial organizations could have significant implications to short term and long-term business strategies.

How You Will Achieve It

License Center Function:
1) Licensing backup support for PGS sites in the U.S.
2) Assists with Memphis site's NABP accreditation as well as maintain that status during subsequent re-accreditation process. Provides information for all NABP requests including policies and procedures, site surveys on periodic basis.

DEA Compliance Support:
3) Provide Center DEA function back up support in the oversight for Plants, R&D, Logistics centers and LSPs.
4) Advising MLC on DEA-related matters such as training on regulations in order to ensure compliance, preparing for associated inspections, inventory requirements, import/export compliance, creation/auditing of applicable SOPs, and reporting potential theft/loss of products.
5) Serve as Memphis Facility SME regarding all applicable DEA regulations for the storage and distribution of regulated controlled substances - examples include inventory requirements, maintenance of an inspection file, point person during regulatory inspections, all communication

with DEA representatives, formal reporting of DEA losses, SME for onsite consulting, signatory of applicable SOPs, maintenance of all applicable licenses.
6) Responsible for compliance with all related Import/Export regulations as they pertain to Pfizer's Controlled Substance distribution. Includes processing of 236 Forms, re-exportation regulations and guidance provided to other Pfizer sites as needed. Knowledge of INCB regulations needed for movement of such product within foreign countries either prior to import or after export from the U.S.
7) Manages compliance programs for 21 CFR 1300 to end, and applicable SOPs. Develops and implements policies and procedures which minimize the exposure to the adverse effects of non-compliance.
8) Support Center function in the development of reports for all required Business Intelligence and other reports used by logistics and customer service operations for DEA. Works directly with IT systems departments to ensure all applicable reports and documents (i.e. invoices/packing lists) are in compliance with DEA and State Board of Pharmacy regulations Management of maintenance of all capabilities for reporting on related system transitions from SAP. Supports DEA compliance assessment programs.
9) Consulting with CSCF management and Pfizer's legal counsel when legal action is taken against Pfizer for alleged inappropriate actions by Pfizer regarding controlled substance or listed chemical handling.
10) Identifying and acting upon opportunities to promote and strengthen Pfizer's relationship with DEA, and/or our customers.
11) Maintaining written documentation of DEA approvals and agreements.

Import/Export:
12) Manage and serve as DEA Import Site Administrator for the Memphis Logistics Center, and the pharmaceutical imports into 3PL sites.

Qualifications

Must-Have

• Applicant must have HS Diploma with 10 years of relevant experience;

OR an Associate's degree with eight years of experience;

OR a Bachelor's degree with at least five years of experience;

OR a Master's degree with more than three years of experience;

OR a Ph.D. with 0-2 years of experience.

• Related industry experience in handling DEA matters at the Washington DC and local levels of the DEA
• Experience with controlled substances and listed chemical requirements is required
• Must have sound knowledge of product lines, processes and associated technologies to effectively facilitate communication with stakeholders
•Previous experience in regulatory interpretation of government regulations via compliance and/or regulatory affairs positions is necessary

• Must possess ability to think strategically, strong attention to detail and ability to problem solve
• Must operate with highest level of integrity, professionalism and exhibit sound judgement at all levels
• Proficient in MS Office Applications (i.e., Excel, PowerPoint, Word, Outlook)
• Strong oral and written communication skills
• Comprehensive/Working knowledge of Drug Enforcement Agency (DEA) regulations with particular emphasis on Schedule II, all controlled drugs and listed chemical requirements
• Experience interacting with State and Federal regulatory officials
• Knowledge and experience in DEA required records (e.g. DEA Forms 222, 236, 357, 161, etc.)
• Knowledge and experience in receipt, dispensing, manufacturing, packaging, storage, shipping, and destruction of controlled substances (CS) in compliance with State and Federal regulations
• Knowledge and experience in conducting CS investigations.
• Ability to analyze and troubleshoot issues, identify CAPAs and proposed actions
• Knowledge and experience in reviewing CS SOPs to ensure CS requirements are met
• Familiar with Good Manufacturing/Good Distribution practices and other regulatory requirements

Nice-to-Have

• Experience working in pharmaceutical industry
• SAP knowledge
• Familiar with Good Manufacturing/Good Distribution practices and other regulatory requirements
• Regulatory experience

Physical/Mental Requirements

Sitting, standing, walking, ability to perform complex analyses and presenting to stakeholders

Non-Standard Work Schedule, Travel or Environment Requirements

10-20% travel

Work Location Assignment:On Premise

Other Job Details

• Last Date to Apply: December 6, 2022

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

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.

Regulatory Affairs

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