The Global WRD Controlled Substance Lead is the central point of contact for Pfizer's R&D Sites globally. Monitor and maintain a high level of compliance of controlled substances regulatory requirements across sites in those areas. Manage sites self-assessments programs and gap closure plans.ROLE RESPONSIBILITIES
- Actively monitor and ensure compliance with all controlled substance regulations, state laws/rules, and applicable corporate and site level SOPs.
- Provide SME support to all applicable controlled substance regulations for the R&D manufacturing, testing, storage and shipment of regulated controlled substances - examples include inventory requirements, maintenance of an inspection file, regulatory inspections support, and support for reporting of thefts and losses.
- Coordinate the DEA Quota process for WRD sites in the U.S. as needed.
- Serve as point of contact for inquiries by CSCF and coordinates support for L1, L2 and L3 audits of sites related to WRD sites globally.
- Provide SME support for consulting, signatory of applicable SOPs, maintenance of all required controlled substance licenses.
- Responsible for developing, monitoring, standardizing and supporting site's Controlled Substances assessment program globally. Ensure gaps to Corporate standards are documented and closed per PGS sites defined processes and systems. Responsible for driving consistent compliance with required regulatory agencies regulations, Pfizer policies and procedures across controlled substance sites.
- Responsible to monitor compliance with all related Import/Export regulations as they pertain to site's Controlled Substance distribution. Includes supporting the processing of required forms and knowledge of INCB regulations for movement of such product either prior to import or after export.
- Establish & actively manage strong performance-based relationships with CS Network and regulatory agencies, clearly defining compliance expectations for regulatory authorities.
- Lead controlled substance training development for site WRD personnel.
- Oversee inventory accountability and reconciliation for all controlled substances at designated sites.
- Provides inputs for updating and improving the Corporate Controlled Substance standard and overall program. Ensure all WRD sites are knowledgeable and formally trained on the CS Corp Standard and other applicable regulations.
- Interact with in country Regulatory Officials as required.
- The communication of site Controlled Substances activities to CS Network lead.
- Providing expert counsel for addressing issues that impact Pfizer's compliance with controlled substance requirements
- Consulting with Pfizer's legal counsel when legal action is taken against Pfizer for alleged inappropriate actions by Pfizer regarding controlled substance or listed chemical handling.
- Identifying and acting upon opportunities to promote and strengthen Pfizer's relationship with regulatory agencies, and/or our customers.
- Providing support to other sites or CSCF management as necessary
- Bachelor's Degree in related field with 5+ years of related industry experience in handling controlled substance matters OR
- Master's Degree in related field with 1+ years of related industry experience in handling controlled substance matters OR
- Associate's Degree in related field with 8+ years of related industry experience in handling controlled substance matters OR
- High School Diploma or Equivalent with 10+ years of related industry experience in handling controlled substance matters.
- Experience working in pharmaceutical industry.
- Experience leading a dispersed team.
- 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.
- Master's Degree preferred
- Familiar with Good Manufacturing/Good Distribution practices and other regulatory requirements
- Regulatory experience
Sitting, standing, walking, ability to perform complex analyses and presenting to stakeholdersNON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- May require up to 20% travel
- Work Location Assignment:Flexible
Last Day to Apply: 09 DECEMBER 2022
For roles based in Colorado: The annual base salary for this position ranges from $93,200.00 to $155,400.00. In addition, this position offers an annual bonus with a target of 15.0% 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.
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.